[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"constipation---functional\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:constipation---functional":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,19,0,[8,52,78,108,130,158,197,217,234,266,290,319,351,376,400,434,462,486,513],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":40,"lastUpdatePostDateStruct":41,"startDateStruct":44,"completionDateStruct":46,"leadSponsor":48,"locationsCount":51},"100609382","nutritional-intervention-for-constipation-symptoms-in-patients-with-parkinsons-disease-100609382",false,"NCT07213856","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease","Nutritional Intervention for Constipation Symptoms in Patients With Parkinson's Disease: A Randomized Clinical Trial","NUTRI-GUT-PD","Inclusion Criteria:\n\n* Adults with a previous diagnosis of Parkinson's disease\n* On a stable dose of levodopa for at least 3 months\n* Diagnosis of Functional Constipation by the Rome IV protocol\n\nExclusion Criteria:\n\n* Diagnosis of atypical or secondary parkinsonism\n* Hoehn and Yahr stage greater than 2\n* Presence of severe neurological or psychiatric disorders that impair the ability to participate in study procedures\n* Previous diagnosis of dementia\n* Presence of comorbidities such as active cancer, chronic obstructive pulmonary disease (COPD), heart failure, and\u002For chronic kidney disease\n* History of gastrointestinal cancers, inflammatory bowel diseases, or surgeries involving the gastrointestinal tract\n* Constipation secondary to clinical conditions such as hypothyroidism or diabetes mellitus\n* Use of opioids\n* Use of probiotics or antibiotics in the past 8 weeks\n* Continuous use of laxatives in the past 8 weeks\n* Presence of severe dysphagia according to the Functional Oral Intake Scale (FOIS)\n* Individuals receiving enteral or parenteral nutrition\n* Individuals under nutritional follow-up in the past 3 months","ALL","18 Years",{"count":20,"type":21},54,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate whether a dietitian-guided nutritional intervention can improve constipation symptoms in people with Parkinson's disease (PD). The main questions it aims to answer are:\n\n* Can a dietitian-guided nutritional intervention increase the number of weekly bowel movements in individuals with PD and functional constipation?\n* Can this intervention positively influence gut microbiota composition, dietary intake, and nutritional status?\n\nResearchers will compare the intervention group to a control group that will receive general dietary guidance only after the study period, to see if the intervention leads to improvements in bowel function and related health outcomes.\n\nParticipants will:\n\n* Follow a diet plan developed by a dietitian, based on dietary reference intakes and tailored to the needs of individuals with PD and constipation\n* Participate in follow-up sessions with the dietitian for 3 months\n* Complete assessments at baseline, midpoint, and end of the intervention to evaluate bowel function, constipation symptoms, gut microbiota, nutritional status, and diet quality",[27,28],"Parkinsons Disease (PD)","Constipation - Functional",[30,31,32,33,34,35,36,37,38],"Microbiota","Diet","Diet, Protein-Restricted","Diet Therapy","Diet, Healthy","Nutrition Therapy","Constipation","Non-Motor Symptoms","Nutritionists","RECRUITING","2026-06-15",{"date":42,"type":43},"2026-06-16","ACTUAL",{"date":45,"type":43},"2026-04-02",{"date":47,"type":21},"2029-08",{"name":49,"class":50},"Hospital de Clinicas de Porto Alegre","OTHER",1,{"id":53,"slug":54,"hasResults":11,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":4,"eligibilityCriteria":58,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":65,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100602654","peristeen-light-explorative-clinical-investigation-100602654","NCT07126327","Peristeen Light Explorative Clinical Investigation","An Explorative Clinical Investigation to Understand the Clinical Benefits of Peristeen Light","Inclusion Criteria:\n\n* Has given written informed consent\n* Is at least 18 years old\n* Has full legal capacity\n* Is able (assessed by investigator) and willing to adhere to clinical investigational procedures during clinical investigation-al duration\n* Has access to and is able to use a smartphone\n* Has constipation and\u002For faecal incontinence based on one or more of the following symptoms during the last 3 month: Straining in more than 25% of defecations, lumpy stools (Bristol Stool Type 1 and 2) in more than 25% of defecations, sensation of incomplete evacuation in more than 25% of defecations, sensation of anorectal obstruction\u002Fblockage in more than 25% of defecations, need to use manual maneuvers to facilitate defecation in more than 25% of defecations, fewer than three spontaneous bowel movements per week, loose stools are rarely present without use of laxatives, recurrent uncontrolled passage of faecal material (other words to describe this could be: Soiling, leak-age, passive faecal incontinence of flatus, mucus and\u002For stool)\n* Is assessed (by investigator) to have a need for low-volume TAI minimum every other day\n\nExclusion Criteria:\n\n* Is participating in any other clinical investigation during this investigation\n* Has previously completed this investigation\n* Is former or current user of transanal irrigation (low- and high volume)\n* Has known hypersensitivity towards the device used in the investigation\n* Is pregnant\n* Has known anal stenosis\n* Has active\u002Frecurrent colorectal cancer\n* Has had anastomotic colorectal surgery within the last 3 months\n* Has ischaemic colitis\n* Has active inflammatory bowel disease\n* Has acute diverticulitis or diverticular abscess\n* Has medicine induced constipation (e.g. due to opioids)\n* Has chronic diarrhea\n* Has bowel dysfunction due to neurogenic disorder(s)\n* Is in need of high-volume TAI (as estimated by investigator)",{"count":60,"type":21},60,[24],"The goal of this exploratory clinical investigation is to understand the clinical benefits of Peristeen Light in adult patients with faecal incontinence, chronic constipation and\u002For time-consuming bowel management procedures.\n\nThe primary objective is to evaluate changes in bowel-function when using Peristeen Light. Participants will use Peristeen Light for 12 weeks test period.",[64,28],"Faecal Incontinence",[66],"trans anal irrigation","2026-04-13",{"date":69,"type":43},"2026-04-14",{"date":71,"type":43},"2025-11-10",{"date":73,"type":21},"2026-08-01",{"name":75,"class":76},"Coloplast A\u002FS","INDUSTRY",2,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":86,"maxAge":18,"enrollmentInfo":87,"targetDuration":4,"studyType":22,"phases":89,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":51},"100632917","improvement-of-understanding-of-pediatric-sacral-neuromodulation-therapeutic-strategies-and-outcome-variables-100632917","NCT07519915","Improvement of Understanding of Pediatric Sacral Neuromodulation: Therapeutic Strategies and Outcome Variables","Stimulation Modeling and Adaptive Response Tracking in Pediatric Gastrointestinal Motility Disorders","SMART-GUT","Inclusion Criteria:\n\n* informed consent of patient and care taker\n* gastrointestinal motility disorder, disregarding underlying diseases\n* exclusion of mechanical obstructions in the gastrointestinal passage\n* age between 3 and 18\n\nExclusion Criteria:\n\n* pregnancy\u002Fbreast feeding\n* decreased renal or thyroidal function\n* drug intake of Beta-blockers, antispasmodics, cyclopropane, bisulfite compounds, haloperidol, heroin, meperidine, metamizole, methadone, morphine, nitrofurantoin, opium alkaloids, phenobarbital, phenylbutazone, probenecid, rifamycin\n* contradictions for MRI\n* indication for analgosedation for MRI\n* inflammatory bowel diseases\n* fractures\u002Fdifferent anatomy in sacral region\n* epilepsy\n* presence of cardiac pacemakers","3 Years",{"count":88,"type":21},25,[24],"The goal of this study is to learn about the effects of sacral neuromodulation in pediatric patients with gastrointestinal motility disorders. By combining advanced neuroimaging, patient-specific biophysical modeling, electrophysiological characterization, and clinical translation, the SMART-GUT project establishes a comprehensive framework to systematically investigate neuromodulation in this pediatric population. This integrative approach enables a direct link between mechanism, targeting, and clinical outcome.",[92,93,28],"Gastrointestinal Motility Disorders in Children","Hirschsprung Disease",[95,96,97,98],"pediatric gastrointestinal motility disorders","chronic constipation","Hirschsprung disease","sacral neuromodulation","2026-04-06",{"date":101,"type":43},"2026-04-09",{"date":103,"type":43},"2018-07-01",{"date":105,"type":21},"2029-12-31",{"name":107,"class":50},"Friedrich-Alexander-Universität Erlangen-Nürnberg",{"id":109,"slug":110,"hasResults":11,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":4,"eligibilityCriteria":114,"healthyVolunteers":11,"sex":115,"minAge":18,"maxAge":116,"enrollmentInfo":117,"targetDuration":4,"studyType":22,"phases":118,"briefSummary":119,"conditions":120,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":51},"100608509","chronic-ingestion-of-fructooligosaccharide-and-psyllium-on-intestinal-transit-in-women-with-functional-constipation-a-randomized-crossover-trial-100608509","NCT07202481","Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit in Women With Functional Constipation: A Randomized Crossover Trial","Effects of Chronic Ingestion of Fructooligosaccharide and Psyllium on Intestinal Transit Time in Women Diagnosed With Functional Constipation: A Randomized, Crossover, Double-Blind Clinical Trial","Inclusion Criteria\n\n* Female participants aged 18-59 years.\n* Willingness to sign the Informed Consent Form .\n* No restrictions on the consumption of egg or gluten.\n* No history or diagnosis of gastrointestinal diseases other than functional constipation.\n* Non-smokers.\n* No use of prebiotics, probiotics, synbiotics, or antibiotics at least 10 days prior to the study.\n* No previous surgery affecting gastrointestinal transit.\n* Willingness to discontinue the use of laxatives at least 4 days prior to scintigraphic imaging.\n* Participants who do not consume adequate dietary fiber (25-30 g\u002Fday) as assessed by dietary recall.\n* No confirmed or suspected pregnancy during the study.\n* No self-reported menopause\n\nExclusion Criteria\n\n* Diagnosis of diabetes, severe hyperthyroidism, or hypothyroidism.\n* Use of opioid medications.\n* Delayed gastric emptying at 4 hours during the placebo period (participants meeting this criterion will be excluded from final analysis).","FEMALE","59 Years",{"count":88,"type":21},[24],"The goal of this clinical trial is to evaluate the effect of dietary fibers in the treatment of functional constipation in women. It will also assess the potential side effects associated with fiber consumption. The main questions it aims to answer are:\n\n* In women with constipation who do not consume adequate dietary fiber, does supplementation help improve bowel function?\n* Among the fibers studied, is there any hierarchy of effect in the treatment of constipation (i.e., is one more effective than the other)?\n\nThe researchers will compare the effects of the two dietary fibers against each other and against a control to evaluate their impact.\n\nParticipants will:\n\n* Consume 20 g of fiber daily for 6 days, divided into two doses of 10 g each.\n* Attend a nuclear medicine visit at the end of each 6-day fiber period to perform scintigraphy.\n* Keep a daily record of bowel habits and dietary intake.",[28],"2026-03-21",{"date":123,"type":43},"2026-03-24",{"date":125,"type":43},"2026-03-14",{"date":127,"type":21},"2027-12",{"name":129,"class":50},"Federal University of Minas Gerais",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":138,"targetDuration":4,"studyType":22,"phases":140,"briefSummary":141,"conditions":142,"keywords":143,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":4},"100625844","effectiveness-and-safety-of-benemix-in-constipation-100625844","NCT07427914","Effectiveness and Safety of Benemix® in Constipation","Evaluation of the Effectiveness and Safety of Benemix®, a Functional Food, in the Management of Constipation in Adults","(Benemix-UdeA)","Inclusion Criteria:\n\n* Adults (≥18 years old) who use Benemix® for the management of constipation.\n* Participants who are using the product for the first time.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women.\n* Individuals with a diagnosis of severe gastrointestinal diseases, mental disorders, hemophilia, and\u002For cancer.\n* Individuals who have used laxatives within the last 7 days.",{"count":139,"type":21},80,[24],"The goal of this clinical trial is to find out whether the functional food Benemix® helps treat constipation in adults and whether it is safe to use.\n\nThe main questions this study aims to answer are:\n\nDoes Benemix® help improve bowel movement frequency and consistency in adults with constipation?\n\nWhat medical problems, if any, do participants experience while taking Benemix®?\n\nAdults with constipation will take Benemix® every day for 15 days. During the second week, participants will have either an in-person clinic visit or a telemedicine appointment for checkups and tests.\n\nParticipants will also receive follow-up phone calls to record:\n\n* daily treatment adherence\n* signs and symptoms\n* the number of bowel movements each day.",[28],[28,144,145,146,147],"Funtional food","Turmeric","Onion","Magnesium","NOT_YET_RECRUITING","2026-02-16",{"date":151,"type":43},"2026-02-23",{"date":153,"type":21},"2026-07",{"date":155,"type":21},"2026-12",{"name":157,"class":50},"Universidad de Antioquia",{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":167,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":170,"conditions":171,"keywords":183,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":188,"lastUpdatePostDateStruct":189,"startDateStruct":191,"completionDateStruct":193,"leadSponsor":195,"locationsCount":51},"100622820","soluble-and-osmotic-fibre-solos-diet-for-constipation-100622820","NCT07388589","Soluble and Osmotic Fibre (SOLOS) Diet for Constipation","The Soluble and Osmotic Fibre (SOLOS) Diet for Functional Bowel Disorders With Constipation","SOLOS","Inclusion Criteria:\n\n* Presented with symptoms of FC, IBS-C, or SIBO-C\n* Were aged 18 to 70 years old. (Research focus is on adult patients, excluding older adults and children)\n* Date of baseline (first) and follow-up appointments ranged from January 2021 to December 2025\n* Did not attend follow-up appointments (Data would be treated as \"intention to treat\" and data points were carried forward for conservative analysis).\n\nExclusion Criteria:\n\n* Had no history of constipation-related symptoms (Does not relate to research question's population or outcome)\n* Started treatment before January 2021\n* Were not due for follow-up before the end of December 2025\n* Symptom and stool data inadequately recorded","70 Years",{"count":168,"type":21},180,"OBSERVATIONAL","This research aims to study the dual effectiveness of incorporating soluble fibre and osmotic carbohydrates (SOLOS), with or without restricting fructans and GOS, and present novel findings in managing GI symptoms in patients with functional bowel disorders with constipation. These findings may also support researchers and clinicians in shaping new dietary approaches in the management of general constipation symptoms.",[36,28,172,173,174,175,176,177,33,178,179,180,181,182],"Constipation Chronic Idiopathic","Constipation Predominant Irritable Bowel Syndrome","Constipation, Signs and Symptoms, Digestive","Constipation-predominant IBS (IBS-C)","Constipation-predominant Irritable Bowel Syndrome","Constipation-predominant Irritable Bowel Syndrome (IBS-C)","Diet Modification","Diet, Food and Nutrition","Dietary and Nutritional Therapies","Dietary Fiber","Dietary Fibers",[36,184,185,186,187],"Functional constipation","Constipation-predominant irritable bowel syndrome (IBS-C)","Soluble fiber","osmotic sugar","2026-02-04",{"date":190,"type":43},"2026-02-06",{"date":192,"type":21},"2026-02-02",{"date":194,"type":21},"2027-03-01",{"name":196,"class":50},"Singapore Institute of Technology",{"id":198,"slug":199,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":201,"acronym":4,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":203,"targetDuration":4,"studyType":22,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":211,"completionDateStruct":213,"leadSponsor":215,"locationsCount":51},"100622682","the-efficacy-and-safety-of-microbiota-transplantation-combined-with-prebiotics-for-treatment-of-functional-constipation-100622682","NCT07386795","The Efficacy and Safety of Microbiota Transplantation Combined With Prebiotics for Treatment of Functional Constipation","Inclusion Criteria:\n\n* Diagnosed with functional constipation (FC) according to Rome IV criteria.\n* Symptoms persisting for at least 6 months, with criteria met for the last 3 months.\n* Ineffective response to traditional treatments (dietary intervention, at least 2 types of laxatives, or probiotics).\n* Willing to discontinue other constipation medications, herbal medicines, or supplements during the study.\n\nExclusion Criteria:\n\n* History or clinical evidence of mechanical bowel obstruction (e.g., tumor or hernia).\n* Diagnosis of megarectum, megacolon, or pseudo-obstruction.\n* Organic intestinal abnormalities (obstruction, stenosis, cancer) or inflammatory bowel disease (IBD).\n* Progressive colorectal polyps requiring treatment.\n* History of gastrointestinal or abdominal surgery within the past 3 months.\n* Severe cardiovascular or cerebrovascular diseases.\n* Clinically significant liver function abnormalities (ALT\u002FAST \\> 2x ULN, TBIL ≥ 1.5x ULN).\n* Pregnancy, lactation, or planning to conceive during the study.\n* Inability to undergo colonoscopy or catheter placement.\n* Participation in other clinical trials within the past 3 months.\n* Other health conditions deemed unsuitable by the investigator.",{"count":5,"type":21},[24],"Chronic constipation is a common gastrointestinal disorder with a global prevalence of approximately 15%, severely impacting daily life and quality of life. It also increases the mortality rate from hypertension, cardiovascular diseases, and ischemic stroke, and is closely related to the incidence of colorectal cancer, making it a major chronic disease that seriously threatens people's health and quality of life. With the increasing aging population and lifestyle factors such as sedentary behavior and low-fiber diets, the incidence of functional constipation is gradually rising. Traditional treatment of chronic constipation mainly relies on various types of laxatives, which have significant side effects with long-term use and relatively high treatment costs, while surgical treatment has limited patient acceptance. Gut microbiota is closely related to intestinal motility, and patients with chronic constipation often have gut microbiota dysbiosis, with significant differences in gut microbiota diversity and colonic mucosal microbiota structure compared to healthy individuals. In recent years, more and more studies have found that intestinal microbiota-based therapies such as probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT) can effectively prevent and treat chronic constipation. FMT, as a method to reshape the gut microbiota, has been widely used in many centers at home and abroad, for diseases including inflammatory bowel disease, irritable bowel syndrome, autism, and obesity. The overall adverse reaction rate in clinical applications is approximately 3%, mainly consisting of abdominal discomfort (bloating, abdominal pain), diarrhea, and secondary intestinal infections or even bacteremia (rare). Our center has established a fecal microbiota transplantation center at Beijing Sixth Hospital within our medical alliance. We have currently performed nearly 100 cases of FMT for the treatment of IBD, autism, functional bowel diseases, and other metabolic diseases, with a clinical efficacy rate of 64-85% for functional constipation and constipation-predominant irritable bowel syndrome. This project aims to validate an intervention strategy combining fecal microbiota transplantation (FMT) with prebiotics primarily composed of high dietary fiber, based on the theoretical framework developed by the team led by Diwei Zheng at the Institute of Process Engineering, Chinese Academy of Sciences.The team found that the core microbiota playing a major role in the FMT process determines the therapeutic efficacy of FMT on diseases.These core microbial communities can produce acetic acid and butyric acid, which are important metabolites that not only reduce inflammatory levels and improve intestinal barrier function, but also provide energy for intestinal epithelial cells. Additionally, they effectively limit the growth of opportunistic pathogens by acidifying the intestinal environment, exerting antibacterial effects, and utilizing niche effects.Therefore, when the core microbiota occupies a dominant ecological niche in the gut, the gut microbiota can support health from multiple aspects including nutrition, immunity, metabolism, and psychology. Prebiotics designed based on the characteristics of the core microbiota can significantly enhance the activity and colonization of the core microbiota.This study aims to reconstruct a healthy intestinal ecosystem through FMT and prebiotics. Simultaneously, it proposes a \"co-localization\" strategy, which involves physically mixing prebiotics with core microbiota during transplantation to coexist synergistically. This approach enhances the metabolic function of core microbiota more efficiently locally, promotes the production of key metabolites such as acetic acid and butyric acid, and improves the intestinal microenvironment.Compared with the traditional stepwise model of 'microbiota transplantation + prebiotic intervention', this approach can significantly reduce the dosage of prebiotics, thereby further enhancing the safety and tolerability of the intervention.This clinical study is designed as an open-label, single-arm trial, aiming to enroll 19 patients with refractory functional constipation to receive \"core microbiota transplantation based on co-localization\".The study will focus on evaluating the therapeutic efficacy of the treatment in improving constipation symptoms, systematically assessing its safety, and comprehensively evaluating the level of gut microbiota remodeling through microbiome and metabolome approaches.The implementation of this project will provide clinical evidence for exploring the application of core microbiota therapy in functional bowel disorders such as constipation, and lay the foundation for optimizing and promoting microecological intervention strategies.",[28,207,208],"Chronic Constipation","Fecal Microbiota Transplantation","2026-01-27",{"date":188,"type":43},{"date":212,"type":21},"2026-02-01",{"date":214,"type":21},"2026-12-31",{"name":216,"class":50},"Peking Union Medical College Hospital",{"id":218,"slug":219,"hasResults":11,"nctId":220,"briefTitle":221,"officialTitle":221,"acronym":4,"eligibilityCriteria":222,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":223,"targetDuration":4,"studyType":22,"phases":225,"briefSummary":226,"conditions":227,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":229,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":233,"locationsCount":51},"100622771","the-safety-and-efficacy-of-fecal-microbiota-transplantation-combined-with-nutritional-intervention-in-the-treatment-of-functional-constipationa-pilot-study-100622771","NCT07387952","The Safety and Efficacy of Fecal Microbiota Transplantation Combined With Nutritional Intervention in the Treatment of Functional Constipation：a Pilot Study","Inclusion Criteria:\n\n1. Age: 18 to 70.\n2. Diagnostic criteria: Functional constipation (FC) in accordance with Rome IV criteria, which should meet the following conditions:\n\n   * Symptom requirements: The following at least 2 items should occur in ≥25% of bowel movements: a. Straining during defecation; b. Hard stool (Bristol Stool Classification score 1-2); c. Feeling of incomplete evacuation; d. Rectal obstruction sensation; e. Need for finger assistance during defecation; f. Spontaneous bowel movements \\\u003C3 times per week.\n   * It is rare to have loose stools without laxatives.\n   * Exclusion of irritable bowel syndrome (IBS): IBS diagnosis criteria not meeting Rome IV.\n   * Disease course requirements: Symptoms persist for at least 6 months and meet the above criteria within the last 3 months.\n3. Traditional treatment methods (dietary intervention, at least two laxatives or probiotics) are ineffective.\n\nExclusion Criteria:\n\n1. Pregnancy or lactation.\n2. Unable to take the intervention product or complete the examination as required.\n3. Language expression disorder or mental illness.\n4. Physical examination showed severe liver and kidney dysfunction.\n5. Acute gastrointestinal disease within 4 weeks.\n6. Constipation caused by surgery in the past 4 weeks.\n7. History or abnormal examination: cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, mental illness, stroke, heart disease, cirrhosis, renal failure, hematopoietic system diseases, organic bowel disease suggested by colonoscopy or imaging.\n8. Participation in other clinical trials within 3 months prior to enrollment.\n9. Other health problems are not suitable for participation in the study.",{"count":224,"type":21},5,[24],"Chronic constipation is a common gastrointestinal disease with a global prevalence of about 15%, significantly affecting daily life and quality of life. Traditional treatments primarily rely on laxatives, which may lead to adverse effects with prolonged use, while surgical interventions have limited patient acceptance. Recent studies indicate that gut microbiota therapies-including probiotics, prebiotics, synbiotics, postbiotics, and fecal microbiota transplantation (FMT)-can effectively manage chronic constipation. This study aims to investigate the safety and efficacy of FMT combined with a prebiotic nutritional intervention (using a co-localization strategy) in the treatment of functional constipation. Additionally, the investigators will explore changes in fecal microbiota and metabolomic profiles following the treatment.",[28,228,207],"Fecal Microbiota Transplantation (FMT)",{"date":188,"type":43},{"date":231,"type":43},"2025-07-30",{"date":214,"type":21},{"name":216,"class":50},{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":238,"acronym":4,"eligibilityCriteria":239,"healthyVolunteers":240,"sex":17,"minAge":241,"maxAge":242,"enrollmentInfo":243,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":245,"conditions":246,"keywords":252,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":257,"lastUpdatePostDateStruct":258,"startDateStruct":260,"completionDateStruct":262,"leadSponsor":264,"locationsCount":4},"100618878","co-development-and-validation-of-colonic-symptom-pictograms-for-young-people-100618878","NCT07337343","Co-Development and Validation of Colonic Symptom Pictograms for Young People","Inclusion Criteria:\n\nChildren and Young people are aged between 8-17 years,\n\n* have lower gut or constipation symptoms,\n* can communicate in English or be supported to participate by a caregiver, whānau, or other responsible person. Phase Four will include international invitations to participants with lower gut or constipation symptoms. Healthy volunteers will not be recruited.\n\nExclusion Criteria:\n\n* Children and Young people with developmental or cognitive disorder that precludes their ability to understand the study,\n* Children and Young people who do not have access to a digital device with internet connectivity,\n* unable to read English,\n* parent does not consent",true,"8 Years","17 Years",{"count":244,"type":21},120,"Severe constipation affects 10% of children, often leading to significant physical and emotional distress. While constipation is commonly associated with impaired bowel movements, it is fundamentally linked to abnormalities in colonic motility - the coordinated contractions that facilitate passage of stool through the colon and out of the body. Diagnosis of constipation is based upon the Rome IV criteria, which assess symptoms as reported or remembered over the previous 3 months.\n\nHowever, reporting symptoms experienced can be challenging for children and young people for many reasons, such as the overlap of sensations, including fullness, bloating, and discomfort, and an inability to recall or precisely distinguish and describe what they are feeling.\n\nThis study intends to design, develop, and validate symptom pictograms for children aged 8-17 with colonic or lower gut symptoms.",[28,247,248,249,250,251],"Abdominal Pain (AP)","Nausea and Vomitting","Bloating","Flatulence","IBS, Constipation Predominant",[253,254,255,256],"children and adolescents","pictograms","co-design","validation","2026-01-02",{"date":259,"type":43},"2026-01-13",{"date":261,"type":21},"2026-01-01",{"date":263,"type":21},"2027-04-01",{"name":265,"class":50},"University of Auckland, New Zealand",{"id":267,"slug":268,"hasResults":11,"nctId":269,"briefTitle":270,"officialTitle":271,"acronym":4,"eligibilityCriteria":272,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":273,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":280,"lastUpdatePostDateStruct":281,"startDateStruct":283,"completionDateStruct":285,"leadSponsor":287,"locationsCount":51},"100616039","parents-of-children-with-constipation-will-be-asked-about-their-views-on-their-childrens-physical-activity-100616039","NCT07300423","Parents of Children With Constipation Will be Asked About Their Views on Their Children's Physical Activity.","Parents' Experiences of Physical Activity in Their Children With Functional Constipation - A Qualitative Interview Study","Inclusion Criteria:\n\n* Parents of children aged 6-12 years who have functional constipation.\n* Are registered at a pediatric and adolescent medicine clinic in Alingsås or Lerum due to functional constipation and are undergoing treatment for functional constipation.\n\nExclusion Criteria:\n\n* Does not speak or write Swedish.\n* The parent should not have impaired cognitive ability.\n* The child should not have another illness\u002Finjury that could affect the ability to be physically active.\n* The family should not have had the supervisor as a therapist.",{"count":274,"type":21},15,"Children with functional constipation are a large patient group that not only needs to seek care at primary healthcare centers and pediatric clinics, but many of the visits received at the emergency department are related to symptoms of constipation. The personal suffering, physically and psychologically, affects not only the child but the entire family. After the patient has started their medical treatment and received information regarding the diagnosis and dietary advice, healthcare today does not have much more to offer. The physiotherapist has currently no natural part in the team around children with constipation. Regular physical activity is recommended but lacks support in science. Physical activity has been shown to have a good effect, such as stimulating bowel movements, reducing constipation, and improving gut microbiota, in other diagnoses from the gastrointestinal tract such as irritable bowel syndrome. From a physiological perspective, physical activity is good for bowel motility; however, there is a lack of studies that can show evidence that physical activity could alleviate symptoms in functional constipation. The purpose of interviewing parents about their experiences of physical activity in their children with functional constipation is to gain a deeper understanding of physical activity in their children. Parents of 12 to15 children with functional constipation will be collected at two different pediatric clinics in Sweden to participate in the study. The method will be semistructured individual, in-depth, interviews that are transcribed verbatim and analyzed using qualitative content analysis. Both the manifest and the latent message will be analyzed. The result of this qualitative study can lead to generating new and increased knowledge about children with functional constipation and their physical activity, which can fill a knowledge gap as there is sparse previous research in the area. Knowledge from the planned study could be valuable in the long run to improve care for children with functional constipation and could lead to the physiotherapist becoming part of the team around children with functional constipation. The result from the study could also be used as a basis for future studies in the area.",[28],[278,279],"Qualitative Research","physical activity","2025-12-09",{"date":282,"type":43},"2025-12-23",{"date":284,"type":43},"2025-11-14",{"date":286,"type":21},"2026-06-01",{"name":288,"class":289},"Vastra Gotaland Region","OTHER_GOV",{"id":291,"slug":292,"hasResults":11,"nctId":293,"briefTitle":294,"officialTitle":295,"acronym":4,"eligibilityCriteria":296,"healthyVolunteers":240,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":297,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":299,"conditions":300,"keywords":306,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":310,"lastUpdatePostDateStruct":311,"startDateStruct":313,"completionDateStruct":315,"leadSponsor":317,"locationsCount":51},"100602250","validation-of-a-parent-administered-symptom-score-for-unsettled-infants-every-baby-is-unique-100602250","NCT07121062","Validation Of A Parent Administered Symptom Score For Unsettled Infants (Every Baby is UnIQue)","Validation Of A Parent Administered Symptom Score For Unsettled Infants","Inclusion Criteria:\n\n1. Consent to complete the anonymous questionnaire\n2. Parent 18 years old or over\n3. Parent of an infant aged under 12 months old at time of questionnaire completion\n\nExclusion Criteria:\n\n1. Parent does not consent to complete the anonymous questionnaire\n2. Parent under 18 years old\n3. Parent of an infant aged 12 months or older at time of questionnaire completion",{"count":298,"type":21},350,"It's common for infants to be unsettled, especially in the first few months of life. While this is often normal, persistent symptoms can be stressful for families. Parents naturally seek explanations, and common suspected causes include colic, reflux, eczema, and cow's milk allergy (CMA). However, CMA is frequently over diagnosed, which can lead to unnecessary changes such as stopping breastfeeding or switching to expensive specialist formulas.\n\nTo address this, we've developed an online questionnaire to help track and understand symptoms in unsettled infants. Our long-term goal is to use this tool to support more accurate diagnosis of CMA. Before that, we need to test and validate the questionnaire in a general population of infants, including those who are healthy and those with other temporary conditions like a recent immunisation or teething.\n\nThis study involves an anonymous online survey for parents of babies under 12 months old. We aim to collect data from approximately 350 participants. The study will help us assess how well the questionnaire reflects the severity of symptoms and whether it can distinguish between healthy infants and those with underlying issues.\n\nParents will be invited to take part using flyers with a QR code distributed in various healthcare settings, including GP clinics and children's clinics in hospital. The survey is anonymous and hosted on a secure platform. While we don't anticipate the questions to be distressing, we recognise some may touch on sensitive topics. Support resources and study team contact details will be provided.\n\nBy validating this tool, we hope to improve how unsettled behaviour in infants is assessed-reducing unnecessary interventions and better supporting families and healthcare professionals.",[301,302,303,304,28,305],"Colic, Infantile","Milk Allergy, Cow's","Gastro Oesophageal Reflux Disease","Atopic Dermatitis (Eczema)","Congential Hip Dysplasia",[307,308,309],"Infantile colic","Cows milk allergy","Unsettled behaviour","2025-08-06",{"date":312,"type":43},"2025-08-13",{"date":314,"type":21},"2025-09",{"date":316,"type":21},"2026-08",{"name":318,"class":50},"University Hospital Southampton NHS Foundation Trust",{"id":320,"slug":321,"hasResults":11,"nctId":322,"briefTitle":323,"officialTitle":324,"acronym":4,"eligibilityCriteria":325,"healthyVolunteers":240,"sex":17,"minAge":18,"maxAge":326,"enrollmentInfo":327,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":329,"conditions":330,"keywords":338,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":341,"lastUpdatePostDateStruct":342,"startDateStruct":344,"completionDateStruct":346,"leadSponsor":348,"locationsCount":350},"100533123","predicting-treatment-outcomes-in-refractory-constipation-through-brain-connectivity-evaluation-100533123","NCT06221722","Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation","Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study","Inclusion Criteria:\n\n* 18≤ age ≤ 45 years old\n* Right-handed\n* Patients diagnosed as functional constipation according to the Rome IV criteria\n* Informed consent of patients\n\nExclusion Criteria:\n\n* Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)\n* Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)\n* No history of chronic pain, no recent major trauma\n* Drug abuse or tobacco dependence (half a pack or more per day)\n* Combined hypothyroidism and Parkinson's disease\n* Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones\n* History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)\n* Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)\n* Pregnant or lactating women with constipation after delivery\n* Patients with other benign and malignant tumors and autoimmune diseases\n* Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.\n* Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life","45 Years",{"count":328,"type":21},150,"The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:\n\n* Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients\n* Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.\n\nParticipants will receive:\n\n* Standard physiological and psychological assessments of constipation\n* BOLD-fMRI tests\n* Standard protocol and fluoxetine treatment\n\nIf there is a comparison group: Researchers will compare:\n\nRefractory group\u002FFluoxetine sensitive group to see the specific brain alterations.",[28,331,332,333,334,335,336,337],"Refractory Constipation","Fluoxetine","fMRI","Brain Connectivity","Treatment Efficacy","Somatic Symptom","Mental Symptom",[333,339,340],"functional connectivity","refractory constipation","2025-07-22",{"date":343,"type":43},"2025-07-24",{"date":345,"type":43},"2023-11-01",{"date":347,"type":21},"2026-09-01",{"name":349,"class":50},"Xijing Hospital of Digestive Diseases",3,{"id":352,"slug":353,"hasResults":11,"nctId":354,"briefTitle":355,"officialTitle":356,"acronym":357,"eligibilityCriteria":358,"healthyVolunteers":240,"sex":17,"minAge":359,"maxAge":360,"enrollmentInfo":361,"targetDuration":4,"studyType":22,"phases":363,"briefSummary":364,"conditions":365,"keywords":366,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":368,"lastUpdatePostDateStruct":369,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":51},"100598865","the-effects-of-ttns-ttns-combined-with-phus-and-conventional-therapy-with-phus-in-the-treatment-of-pfc-100598865","NCT07077044","The Effects of TTNS, TTNS Combined With PHUS, and Conventional Therapy With PHUS in the Treatment of PFC.","Transcutaneous Electrical Nerve Stimulation in Children With Functional Constipation Monitored by Pocket-sized Point-of-care Ultrasound.","constipation","Inclusion Criteria Children aged 4 to 14 years\n\nClinical diagnosis of functional constipation (FC), with no identifiable organic or anatomical cause (e.g., endocrine, metabolic, anatomical, or neuromuscular dysfunction)\n\nFC diagnosis established according to Rome IV criteria\n\nNo additional tests required to confirm eligibility\n\nAbility to complete daily diaries and TTNS sessions (by participant or caregiver)\n\nFailure of conservative medical treatment (including toilet training and laxatives) after at least three months\n\nExclusion Criteria Malformations of the digestive system and rectal anatomical anomalies (e.g., large intestinal atresia\u002Fstenosis, Hirschsprung's disease, congenital anorectal anomalies)\n\nNeurological or psychiatric disorders (e.g., cerebral palsy, spina bifida, intellectual disability, anorexia nervosa)\n\nMajor cognitive impairment\n\nMetabolic conditions (e.g., diabetes mellitus, diabetes insipidus, scurvy, phenylketonuria)\n\nEndocrine disorders (e.g., hypothyroidism)\n\nCardiac conditions (e.g., heart disease, arrhythmias, presence of pacemaker or ventriculoperitoneal shunt) due to possible interference with electrical stimulation\n\nHistory of thoracic or abdominal surgery\n\nPresence of skin lesions in the area of electrode application\n\nPresence of active electronic implants","4 Years","14 Years",{"count":362,"type":21},64,[24],"This study is a randomized, controlled trial designed to evaluate the effects of transcutaneous tibial nerve stimulation (TTNS), TTNS combined with pocket-sized handheld ultrasound (PHUS), and conventional therapy with PHUS on children with functional constipation (FC). Participants will be stratified into three intervention arms (n=20 per group).\n\nFC will be defined based on the Rome IV diagnostic criteria, in the absence of organic or anatomical causes. Participants will be between 4 and 14 years old and will have experienced failure of conservative treatment for at least three months prior to enrollment.\n\nThe primary outcomes include changes in rectal ultrasound parameters and symptom severity scores. Ultrasound assessments will be conducted by trained clinicians using standardized protocols. Monitoring for adverse events will be performed throughout the intervention phase. Safety considerations include predefined exclusion criteria, such as underlying neurological, metabolic, or cardiac conditions.",[36,28],[367],"children with functional constipation","2025-07-20",{"date":341,"type":43},{"date":371,"type":43},"2024-02-21",{"date":373,"type":21},"2026-02-25",{"name":375,"class":50},"Hadassah Medical Organization",{"id":377,"slug":378,"hasResults":11,"nctId":379,"briefTitle":380,"officialTitle":380,"acronym":4,"eligibilityCriteria":381,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":166,"enrollmentInfo":382,"targetDuration":4,"studyType":22,"phases":383,"briefSummary":384,"conditions":385,"keywords":387,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":51},"100598011","effects-of-lactulose-on-gut-microbiota-and-metabolism-in-diabetic-constipated-patients-100598011","NCT07065942","Effects of Lactulose on Gut Microbiota and Metabolism in Diabetic Constipated Patients","Inclusion Criteria:\n\n* Age: 18-70 years\n* Type 2 Diabetes Diagnosis (per 2017 ADA criteria), meeting ≥1 of:\n\n  1. Fasting plasma glucose (FPG) ≥7.0 mmol\u002FL\n  2. hour plasma glucose ≥11.1 mmol\u002FL during 75g anhydrous oral glucose tolerance test (OGTT)\n  3. Random plasma glucose ≥11.1 mmol\u002FL with hyperglycemia symptoms or hyperglycemic crisis\n* Functional Constipation (Rome IV criteria), requiring:\n\n  1. ≥2 of the following\n\n     1. occurring in ≥25% of defecations\n     2. Straining\n     3. Lumpy\u002Fhard stools (Bristol Stool Scale 1-2)\n     4. Sensation of incomplete evacuation\n     5. Anorectal obstruction\u002Fblockage\n     6. Manual maneuvers required\n     7. \\\u003C3 spontaneous bowel movements\u002Fweek\n  2. No loose stools without laxatives\n  3. Exclusion of IBS diagnosis. Symptom duration \\>6 months, with active symptoms meeting criteria for last 3 months.\n* Stable Glycemic Control: No anticipated antidiabetic medication adjustments during study\n* Dietary Stability: Maintain consistent diet; avoid yogurt, fermented foods, prebiotic-containing processed foods, or other items that may confound results\n\nExclusion Criteria:\n\n* Secondary Constipation due to organic diseases or medication effects.\n* Constipation-predominant Irritable Bowel Syndrome (IBS-C).\n* Concurrent gastrointestinal disorders (e.g., inflammatory bowel disease, colorectal cancer).\n* Type 1 Diabetes Mellitus.\n* Severe chronic comorbidities, including:\n\n  1. Cardiopulmonary insufficiency\n  2. Cerebrovascular diseases\n  3. Psychiatric disorders\n* Recent use (within 1 month) of confounding medications:\n\n  1. Probiotics\u002Fprebiotics\n  2. Antibiotics\n  3. Laxatives (e.g., osmotic\u002Fstimulant agents)\n  4. Prokinetics",{"count":60,"type":21},[24],"Constipation is the most common gastrointestinal manifestation in diabetic patients. Emerging evidence suggests that gut microbiota dysbiosis may contribute to the pathogenesis of diabetes, highlighting the need to investigate its role in diabetic constipation, though current research remains limited.\n\nCurrent management of diabetic constipation primarily relies on bulk-forming and osmotic laxatives. Additionally, microbiome-modulating agents (e.g., probiotics, prebiotics, and synbiotics) may serve as adjunctive therapies by regulating gut microbiota and enhancing intestinal motility. Lactulose, a well-tolerated osmotic laxative with prebiotic effects, is widely recommended in clinical guidelines. It promotes short-chain fatty acid production, increases fecal volume, and accelerates colonic transit, thereby alleviating constipation. However, its specific impact on gut microbiota composition and metabolic pathways in diabetic constipation remains unclear.\n\nThis study aims to explore changes in fecal microbiota and metabolomic profiles in diabetic patients with chronic constipation following treatment with lactulose alone or in combination with Bacillus subtilis-Enterococcus faecium probiotics, providing mechanistic insights into prebiotic therapy for this condition.",[386,28],"Diabetes Mellitus",[388,36,389,390,391],"Diabetes","Lactulose","Gut Microbiota","Metabolism","2025-07-04",{"date":394,"type":43},"2025-07-15",{"date":396,"type":43},"2023-07-01",{"date":398,"type":21},"2026-07-30",{"name":216,"class":50},{"id":401,"slug":402,"hasResults":11,"nctId":403,"briefTitle":404,"officialTitle":405,"acronym":4,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":17,"minAge":359,"maxAge":242,"enrollmentInfo":407,"targetDuration":4,"studyType":22,"phases":408,"briefSummary":411,"conditions":412,"keywords":414,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":425,"lastUpdatePostDateStruct":426,"startDateStruct":428,"completionDateStruct":430,"leadSponsor":432,"locationsCount":51},"100580340","phase-2-a-trial-of-actazin-versus-peg-3350-for-maintenance-therapy-in-children-with-constipation-100580340","NCT06836024","A Trial of Actazin Versus PEG 3350 for Maintenance Therapy in Children With Constipation","Actazin (Kiwifruit Extract) Versus Polyethylene Glycol 3350 for Maintenance Therapy in Children With Constipation: a Feasibility Randomized Control Trial","Inclusion Criteria:\n\n1. Age 4 to 17 years, inclusive; minimum age of 4 years to ensure toileting skills have been acquired and ability to chew and swallow tablets safely.\n2. Fulfill Rome IV diagnostic criteria for FC;60 Must include ≥2 of the following occurring at least once per week for a minimum of 1 month: (i) ≤2 SBMs\u002F week; (ii) ≥1 episode of fecal incontinence\u002Fweek; (iii) retentive posturing; (iv) painful or hard bowel movements; (v) presence of a large fecal mass in the rectum (rectal, abdominal or radiographic exam) and (vi) history of large-diameter stools that can obstruct the toilet.\n3. Participant and their caregivers agree to exclusively use the laxatives provided as part of the trial for a 4-week period, and refrain from using any additional PEG 3350 or kiwifruit\u002Fkiwifruit extracts outside of the trial products.\n\nExclusion Criteria:\n\n1. Organic causes of constipation (e.g., celiac disease, Hirschsprung's disease, spina bifida, anorectal malformations)\n2. Prior enrollment in trial\n3. Not toilet trained; significantly different FC phenotype than toilet trained children\n4. Any known hypersensitivity to kiwifruit, latex, Actazin or PEG 3350\n5. Chronic health conditions (e.g., urolithiasis, ureteropelvic junction obstruction, sickle cell, cerebral palsy, hepatic, hematopoietic, renal, endocrine, or metabolic diseases) that could potentially confound the results of the study\n6. Prior abdominal surgery involving the luminal GI tract, except hernia repairs\n7. Concomitant use of drugs that are known to affect GI motility (e.g., opioids, domperidone, linaclotide)\n8. Prior neuropsychiatric or pervasive developmental disorders such as severe non-verbal ASD, major psychiatric disorders (bipolar disorder, schizophrenia, major depression)\n9. Refractory or severe FC that failed to respond to PEG 3350 and\u002For require combination of several laxative therapies, manual disimpaction, use of any nerve stimulation or antegrade enemas through a cecostomy or an appendicostomy\n10. Absence of a parent\u002Fguardian for children who are not mature minors\n11. Inability to obtain consent due to a language barrier and the absence of language translator in person or by a phone translation service available in the ED",{"count":60,"type":21},[409,410],"PHASE2","PHASE3","The goal of this pilot feasibility randomized controlled trial is to determine whether Actazin (kiwifruit extract) is a feasible and effective alternative to polyethylene glycol 3350 (PEG 3350) for maintenance therapy in children with functional constipation (FC). This study will include children aged 4 to 17 years who meet the Rome IV criteria for functional constipation.\n\nThe main questions it aims to answer are:\n\n1. Is it feasible to conduct a definitive, multi-centre trial comparing Actazin to PEG 3350 in children with FC?\n2. What are the within-group differences in clinical outcomes such as stool frequency, abdominal pain, and laxative use over a 4-week period?\n\nResearchers will compare chewable Actazin tablets with placebo PEG 3350 powder to PEG 3350 powder with placebo Actazin tablets to see if Actazin is a viable non-pharmacologic natural health product alternative for treating FC.\n\nParticipants will:\n\nUndergo an initial bowel cleanout using PEG 3350 and bisacodyl. Following, they will be randomized to one of two groups:\n\n1. Actazin chewable tablets (titrate to effect: 600-2400 mg\u002Fday) + placebo PEG 3350\n2. PEG 3350 (dose based on age and titratable to effect) + placebo Actazin chewable tablets Participants will take the assigned intervention daily for 4 weeks and complete a daily bowel diary recording stool frequency, consistency (Bristol Stool Scale), abdominal pain, and laxative use. They will have weekly follow-ups via phone or electronic survey to assess adherence, medication use, and adverse events.\n\nAdditionally, a bi-weekly follow-up will be conducted for an additional 8 weeks to track longer-term outcomes.\n\nOutcomes:\n\nPrimary feasibility outcomes include consent rate, adherence to allocated intervention, and 4-week follow-up completion rate.\n\nSecondary clinical outcomes include resolution of FC (Rome IV criteria), weekly stool frequency, abdominal pain episodes, use of rescue laxatives, and treatment palatability.\n\nThis study is being conducted at McMaster Children's Hospital and is funded by the Hamilton Academic Health Sciences Organization (HAHSO). Data collection will be managed using the Lumedi™ platform, and safety will be overseen by a Data Safety Monitoring Board (DSMB).",[28,36,413],"Constipation Aggravated",[415,416,417,418,419,420,421,422,423,424],"Functional Constipation","Pediatric Constipation","Actazin","Kiwifruit Extract","Polyethylene Glycol 3350","Laxative Therapy","Randomized Controlled Trial","Feasibility Study","Non-Pharmacologic Treatment","Rome IV Criteria","2025-03-14",{"date":427,"type":43},"2025-03-19",{"date":429,"type":21},"2025-06-01",{"date":431,"type":21},"2027-02-01",{"name":433,"class":50},"Hamilton Health Sciences Corporation",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":439,"acronym":440,"eligibilityCriteria":441,"healthyVolunteers":11,"sex":17,"minAge":442,"maxAge":443,"enrollmentInfo":444,"targetDuration":4,"studyType":169,"phases":4,"briefSummary":446,"conditions":447,"keywords":4,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":453,"lastUpdatePostDateStruct":454,"startDateStruct":456,"completionDateStruct":458,"leadSponsor":460,"locationsCount":51},"100518475","prevalence-and-natural-history-of-functional-gastrointestinal-disorders-among-at-risk-infants-100518475","NCT06031025","Prevalence and Natural History of Functional Gastrointestinal Disorders Among At-risk Infants.","Prospective Assessment of the Prevalence and Natural History of Gastroesophageal Reflux and Functional Gastro-intestinal Disorders Among At-risk Infants","FUSID","Inclusion Criteria:\n\n* infants with gestational age at birth \\\u003C 31 weeks\n* infants with gestational age at birth \\\u003C 37 weeks and major respiratory or neurologic morbidity\n* infants with history of perinatal asphyxia\n\nExclusion Criteria:\n\n* lack of informed consent\n* diagnosis of congenital or other major gastrointestinal disease (i.e. inflammatory bowel disease, cancer)","3 Months","24 Months",{"count":445,"type":21},71,"The goal of this observational study is to learn about the prevalence and characteristics of functional gastrointestinal disorders (FGID) in at risk infants (former preterm infants and those with birth asphyxia) during the first 2 years of life. The main questions it aims to answer are:\n\n* evaluate the prevalence of symptoms related to gastro-esophageal reflux (GER), of functional gastrointestinal disorders during the first 2 years of life\n* describe growth parameters during follow-up up to the corrected age of 2 years Participants will be assessed clinically and with a structured questionnaire based on the Rome IV criteria to describe FGID.",[448,449,28,450,451,301,452],"Functional Gastrointestinal Disorders","Gastroesophageal Reflux","Diarrhea","Dyschezia","Vomiting; Cyclical","2025-03-10",{"date":455,"type":43},"2025-03-11",{"date":457,"type":43},"2022-05-20",{"date":459,"type":21},"2025-09-30",{"name":461,"class":50},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":463,"slug":464,"hasResults":11,"nctId":465,"briefTitle":466,"officialTitle":467,"acronym":4,"eligibilityCriteria":468,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":469,"targetDuration":4,"studyType":22,"phases":471,"briefSummary":472,"conditions":473,"keywords":475,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":477,"lastUpdatePostDateStruct":478,"startDateStruct":480,"completionDateStruct":482,"leadSponsor":484,"locationsCount":4},"100583086","effect-of-a-low-fodmap-diet-in-ibs-and-functional-constipation-with-bloating-a-randomized-double-blind-trial-100583086","NCT06871748","Effect of a Low FODMAP Diet in IBS and Functional Constipation with Bloating: a Randomized Double-Blind Trial","Effect of a Low FODMAP Diet in Irritable Bowel Syndrome and Functional Constipation with Bloating: a Randomized Double-Blind Controlled Trial with Microbiota, Intestinal Gas, and Metabolomic Analysis","Inclusion Criteria:\n\n* Age ≥18 years\n* Diagnosed with Irritable Bowel Syndrome (IBS) or Functional Constipation (FC) based on Rome IV criteria\n* Persistent bloating affecting daily life, with a bloating VAS score ≥4\n* Stable bowel habits with Bristol Stool Form Scale (BSFS) type 3-5\n* History of prior treatment with antispasmodics and\u002For prokinetics (allowed if dose remains stable)\n* Able to comply with dietary intervention and study procedures\n\nExclusion Criteria:\n\n* Prior gastrointestinal surgery (except appendectomy or cholecystectomy)\n* Use of antibiotics, proton pump inhibitors (PPIs), probiotics, NSAIDs, lactulose, or metformin within the past 4 weeks\n* Presence of systemic diseases affecting gut microbiota (e.g., liver cirrhosis, uncontrolled diabetes, end-stage renal disease, obesity, cancer, psychiatric disorders)\n* Inability to consume study meals or follow dietary restrictions",{"count":470,"type":21},34,[24],"This clinical study aims to evaluate the effects of a low FODMAP diet compared to a high FODMAP diet in patients with Irritable Bowel Syndrome (IBS) and Functional Constipation (FC) with predominant bloating. The study is a randomized, double-blind, controlled trial designed to assess whether a diet low in fermentable carbohydrates can improve bloating symptoms, gut microbiota composition, intestinal gas production, and metabolic outputs.\n\nPatients meeting the Rome IV criteria for IBS or FC with persistent bloating will be enrolled and randomly assigned to receive either a low or high FODMAP diet for two weeks. Meals will be standardized to control FODMAPs composition, ensuring that FODMAP content is the primary variable.\n\nThe primary endpoint is the proportion of participants with a ≥30% reduction in bloating severity, measured using the Visual Analog Scale (VAS). Secondary outcomes include changes in global IBS symptoms, abdominal pain, bowel movements, stool consistency, microbiota diversity, hydrogen\u002Fmethane gas production, and metabolomic profiles.\n\nThis study will contribute to the growing body of evidence supporting dietary management in disorders of gut-brain interaction (DGBI), particularly in bloating-predominant IBS and FC, and will provide insights into the mechanisms linking diet, gut microbiota, and symptom improvement.",[474,28,249],"Irritable Bowel Syndrome (IBS)",[474,415,476,30],"FODMAP","2025-03-06",{"date":479,"type":43},"2025-03-12",{"date":481,"type":21},"2025-03-15",{"date":483,"type":21},"2026-07-31",{"name":485,"class":50},"Mahidol University",{"id":487,"slug":488,"hasResults":11,"nctId":489,"briefTitle":490,"officialTitle":490,"acronym":4,"eligibilityCriteria":491,"healthyVolunteers":11,"sex":17,"minAge":492,"maxAge":493,"enrollmentInfo":494,"targetDuration":4,"studyType":22,"phases":496,"briefSummary":497,"conditions":498,"keywords":501,"overallStatus":148,"whyStopped":4,"lastUpdateSubmitDate":504,"lastUpdatePostDateStruct":505,"startDateStruct":507,"completionDateStruct":509,"leadSponsor":511,"locationsCount":51},"100549748","influence-of-modern-colon-hydrotherapy-on-intestinal-transit-100549748","NCT06438068","Influence of Modern Colon Hydrotherapy on Intestinal Transit","Inclusion Criteria:\n\n* Patients between 20 and 60 years of age with functional constipation of more than 5 years of evolution.\n\nExclusion Criteria:\n\n* Taking any type of antibiotic in the last month\n* Taking prebiotics or probiotics products in the last month.\n* Taking laxatives in the last month.\n* Undergoing any medicinal treatment\n* Pregnancy\n* Subject with a history of current gastrointestinal pathology or disorder such as: acute colon pathology, acute haemorrhagic colitis, suspected digestive perforation, recent abdominal surgery, severe arterial hypertension, abdominal hernia, colon neoplasia, history of cardiac syncope, renal failure, liver cirrhosis, epilepsy, severe psychiatric illness (psychosis), necrosis due to abdominal irradiation, severe anaemia, severe neurovegetative lability.","20 Years","60 Years",{"count":495,"type":21},30,[24],"A randomised and controlled trial, in which the effect of Modern Colon Hydrotherapy is evaluated in the gastrointestinal transit of subjects with functional constipation",[28,499,500],"Hydrotherapy","Functional Colonic Diseases",[357,502,503,500],"internal hydrotherapy","Radiopaque Media","2024-08-15",{"date":506,"type":43},"2024-08-16",{"date":508,"type":21},"2024-09",{"date":510,"type":21},"2024-10",{"name":512,"class":50},"Universidad Complutense de Madrid",{"id":514,"slug":515,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":521,"targetDuration":4,"studyType":22,"phases":523,"briefSummary":524,"conditions":525,"keywords":528,"overallStatus":39,"whyStopped":4,"lastUpdateSubmitDate":533,"lastUpdatePostDateStruct":534,"startDateStruct":536,"completionDateStruct":538,"leadSponsor":540,"locationsCount":51},"100523772","the-revo-study-low-volume-vs-high-volume-rectal-irrigation-100523772","NCT06100055","The ReVo Study: Low-volume vs High-volume Rectal Irrigation","The ReVo Study (REctal Irrigation VOlume Study - 'Low Versus High Volume Irrigation - Optimising Rectal Irrigation Volume in Evacuatory Dysfunction'; A Randomised Controlled Trial)","ReVo","Inclusion Criteria:\n\n* All adult patients over 18 years who have self-reported problematic constipation secondary to evacuation disorders\n* With symptom onset of more than 6 months\n* Symptoms must meet American College of Gastroenterology definition of constipation which is symptoms including unsatisfactory defecation with either infrequent stools, difficulty in passing stool or both for at least previous 3 months (25)\n* All should have tried and failed conservative management (laxatives, life-style modification and bio-feedback)\n* Patients should also have ability and willingness to give informed consent.\n* Patients or carer should be able to use rectal irrigation\n\nExclusion Criteria:\n\nPatients with\n\n* Major colorectal resection surgery, pelvic floor surgery to address defaecatory problems such as posterior vaginal repair, STARR, rectopexy and sacral nerve stimulation within last three months\n* Pregnancy\n* Active rectal bleeding\n* Colorectal cancer\n* Complicated diverticular disease or acute diverticulitis\n* Anal or colorectal stenosis\n* Inflammatory bowel disease\n* Undergoing chemotherapy\n* Ischemic colitis\n* Used rectal irrigation in the past one year",{"count":522,"type":21},166,[24],"Rectal irrigation, which is the introduction of warm tap water through the anal canal into the rectum to initiate defaecation, is recommended to be considered in patients with chronic constipation, which is refractory to conservative measures such as lifestyle modification, laxatives, nurse-led bowel retraining programmes which focuses on bio-feedback as well as psychosocial support.\n\nTwo systems of rectal irrigation are available based on volume delivered, low and high volume. It is unknown if one type of irrigation is superior to the other and whether one type has better outcomes in patients with a particular pathology.\n\nTherefore, a comparison is required between the two types of irrigation to assess their acceptability as a therapy and response rates in patients with chronic constipation secondary to difficulty emptying rectum.\n\nThis trial\u002Fresearch aims to compare low-volume rectal irrigation with high-volume rectal irrigation in patients with chronic constipation secondary to disorders of difficulty emptying rectum.\n\nThe main questions it aims to answer are:\n\n* if one type of rectal irrigation is superior to the other\n* whether one type of rectal irrigation has better outcomes in patients with a particular pathology on pelvic floor ultrasound\n* assess the acceptability and response rates to rectal irrigation.\n\nParticipants upon recruitment will be allocated to either low-volume rectal irrigation or high volume rectal irrigation groups. This will purely be by chance where the possibility of being in either of the groups will be 50%. They will then undergo a baseline assessment with four quality-of-life questionnaires and clinical examination. Following this a pelvic floor ultrasound will be performed to assess the cause of their symptoms. Lastly they will be provided training on using rectal irrigation (the type they have been assigned to). They will then be asked to commence irrigation at home from the next day.\n\nParticipants will continue to use irrigation for three months and then have a three-monthly follow-up where the quality of life questionnaires will be filled again. This data will then be used to assess any improvement in symptoms after using rectal irrigation. After three months of using rectal irrigation, participation in the trial will come to and end.",[28,36,526,527],"Constipation by Outlet Obstruction","Defecation Disorder",[96,529,530,531,532],"rectal irrigation","evacuation disorders","low-volume rectal irrigation","high-volume rectal irrigation","2024-07-26",{"date":535,"type":43},"2024-07-29",{"date":537,"type":43},"2024-05-10",{"date":539,"type":21},"2025-07",{"name":541,"class":50},"Guy's and St Thomas' NHS Foundation Trust"]