[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-constipation-fc\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-constipation-fc":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,11,0,[8,45,70,100,130,150,179,206,238,261,289],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100638360","fiber-nutritional-supplement-for-management-of-constipation-during-pregnancy-100638360",false,"NCT07588633","Fiber Nutritional Supplement for Management of Constipation During Pregnancy","Effectiveness of Daily Supplementation of a Fiber Nutritional Supplement (Materna® Opti-fiber) and Counselling for Constipation Management in Pregnancy","Inclusion Criteria:\n\n1. Pregnant women aged 21 years-old or above at recruitment\n2. Gestational age of 13-27 weeks at recruitment\n3. Singleton pregnancy at recruitment\n4. Suffering from functional constipation according to the Cullen 2007 criteria which must include ALL the following and the criteria must be fulfilled for at least two weeks with symptom onset during pregnancy:\n\n   1. Low frequency of stool (\\\u003C3\u002Fweek)\n   2. Hard stools\n   3. Difficulty on evacuation\n5. Able to understand and to sign a written Informed Consent Form (ICF) prior to study enrolment.\n6. Willing and able to comply with the requirements for participation in this study\n7. Willing and able to refrain from consuming other supplements containing fiber, prebiotics, or probiotics other than the Fiber Nutritional Supplement (Materna® Opti-fiber) over the intervention period\n8. Able to respond to questionnaires in English\n\nExclusion Criteria:\n\n1. Treated for constipation less than one week before the start of the study\n2. Use of prebiotics or probiotics containing supplements two weeks prior to the study start\n3. Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial\n4. Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial\n5. Not willing and\u002For not able to comply with the study procedures and requirements\n6. Known serious food allergy\n7. Known or suspected history of allergy or intolerance to the investigational product (IP)\n8. Active participation in another clinical trial or on-going observational study\n9. Family or hierarchical relationships with the research team members",true,"FEMALE","21 Years",{"count":20,"type":21},31,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study aims to evaluate the effectiveness of a daily Fiber Nutritional Supplement (Materna® Opti fiber), containing partially hydrolyzed guar gum (PHGG) and vitamins C, D, zinc, and selenium, combined with nutritional counselling, for the management of constipation during pregnancy. Constipation is a common gastrointestinal complaint in pregnancy and may negatively affect quality of life and well being.\n\nThe study is designed as an open label, single arm intervention conducted in pregnant women between 13 and 27 weeks of gestation who meet the Cullen 2007 criteria for functional constipation. A total of 31 participants are planned for enrolment. Eligible participants will receive one sachet per day of the Fiber Nutritional Supplement (Materna® Opti fiber), providing approximately 5.8 g of PHGG, for a duration of 4 weeks. In addition to the investigational product, all participants will receive standardized constipation counselling at baseline, including education on constipation, lifestyle measures.",[27],"Functional Constipation (FC)",[29,30,31],"constipation","fiber","pregnancy","NOT_YET_RECRUITING","2026-05-11",{"date":35,"type":36},"2026-05-15","ACTUAL",{"date":38,"type":21},"2026-05-08",{"date":40,"type":21},"2026-10-08",{"name":42,"class":43},"Société des Produits Nestlé (SPN)","INDUSTRY",1,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":55,"targetDuration":4,"studyType":22,"phases":57,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100631856","dose-effect-response-in-acupuncture-for-functional-constipation-100631856","NCT07506122","Dose-Effect Response in Acupuncture for Functional Constipation","Response Characteristics of the Dose-Effect Relationship in Acupuncture Treatment for Functional Constipation: A Randomized Controlled Study","Inclusion Criteria:\n\n* Meet Rome IV diagnostic criteria for functional constipation\n* Symptoms present for ≥6 months, meeting diagnostic criteria in the last 3 months\n* Mean weekly complete spontaneous bowel movements (CSBMs) ≤2 during 14-day baseline period\n* Age 18-75 years\n* No use of constipation medications for at least 2 weeks prior to treatment (except rescue medication)\n* No acupuncture treatment for constipation in the past 3 months\n* Not currently participating in another clinical trial\n* Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n* Constipation secondary to other causes (IBS, organic diseases, medications, endocrine disorders, metabolic disorders, neurological disorders, or gastrointestinal surgery)\n* Loose or watery stools (Bristol type 6 or 7) \\>1 time during baseline without laxative use\n* History of pelvic floor dysfunction\n* Use of probiotics, fiber supplements, or laxatives within 2 weeks prior to treatment (2-week washout required)\n* Severe hemorrhoids or anal fissures\n* Severe or uncontrolled heart, liver, or kidney disease; abdominal aortic aneurysm; hepatosplenomegaly; cognitive impairment; or psychiatric disorders\n* Dependence on opioids or anticholinergic drugs\n* Red flags: unexplained weight loss \\>10% in 3 months, hematochezia or positive fecal occult blood, family history of colon cancer (first-degree relative diagnosed \\\u003C50 years), anemia (Hb \\\u003C110 g\u002FL), or elevated inflammatory markers\n* Contraindications to acupuncture: coagulation disorders or use of anticoagulants\n* Pregnancy or breastfeeding\n* Unable to comply with follow-up or contraindications to MRI (e.g., cardiac pacemaker, non-titanium aneurysm clips, metallic implants, claustrophobia)","ALL","18 Years","75 Years",{"count":56,"type":21},72,[24],"This is a single-center, randomized, parallel-group trial evaluating the dose-response relationship of two experimental interventions: manual acupuncture and electroacupuncture for functional constipation.\n\nA total of 72 participants with functional constipation (Rome IV criteria) will be randomly assigned in a 1:1 ratio to either the manual acupuncture group or the electroacupuncture group. Both groups receive acupuncture at bilateral Tianshu (ST25) and Shangjuxu (ST37) points, 30 minutes per session, three times per week for 12 weeks. The electroacupuncture group additionally receives electrical stimulation (continuous wave, 10 Hz, 0.5-4 mA).\n\nThe primary outcome is the responder rate at week 12, defined as the percentage of participants with ≥3 complete spontaneous bowel movements (CSBMs) per week. Secondary outcomes include changes in gut microbiota, brain functional connectivity measured by multimodal MRI and fNIRS, and scales.\n\nThe study aims to clarify the dose-response characteristics of different acupuncture modalities and their underlying biological mechanisms.",[27],"RECRUITING",{"date":62,"type":36},"2026-05-14",{"date":33,"type":36},{"date":65,"type":21},"2027-12",{"name":67,"class":68},"Tongji Hospital","OTHER",2,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":78,"enrollmentInfo":79,"targetDuration":4,"studyType":22,"phases":81,"briefSummary":82,"conditions":83,"keywords":86,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":69},"100617806","transcranial-alternating-current-stimulation-for-refractory-constipation-with-somatic-symptom-disorder-100617806","NCT07323407","Transcranial Alternating Current Stimulation for Refractory Constipation With Somatic Symptom Disorder","A Randomized, Double-Blind, Placebo-Controlled Clinical Trial of Transcranial Alternating Current Stimulation (tACS) for the Treatment of Refractory Constipation Comorbid With Somatic Symptom Disorder","RELIEF-tACS","Inclusion Criteria:\n\n1. Diagnosis of Functional Constipation (FC): Subjects must meet the diagnostic criteria for functional constipation as defined by the Rome IV criteria.\n2. Low Frequency of Complete Spontaneous Bowel Movements (CSBM): During the 2-week screening period, subjects must have ≤2 complete spontaneous bowel movements per week.\n3. Poor Response to Previous Treatment: Subjects must have been dissatisfied with prior treatments for functional constipation and have undergone at least 3 months of therapy (including laxatives or other prokinetic agents).\n4. Diagnosis of Somatic Symptom Disorder (SSD): Subjects must meet the DSM-5 diagnostic criteria for somatic symptom disorder (SSD). All subjects will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   * Criterion A: Presence of one or more distressing somatic symptoms that significantly affect daily life.\n   * Criterion B: At least one of the following must be met:\n\n     1. Excessive and persistent thoughts about the severity of symptoms;\n     2. Persistently high levels of anxiety about health or symptoms;\n     3. Excessive time and energy devoted to health concerns or symptoms.\n   * Criterion C: Symptoms must persist for at least 6 months.\n5. Age Range: Subjects must be between 18 and 80 years old.\n6. No Concurrent Clinical Trials: Subjects must not participate in any other clinical trials during the study period.\n7. Informed Consent: Subjects must voluntarily agree to participate and sign an informed consent form.\n\nExclusion Criteria:\n\n1. Presence of organic diseases (such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, etc.), endocrine disorders (e.g., hypothyroidism), metabolic diseases (diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease);\n2. Long-term use of medications that may affect intestinal function or induce constipation, such as Parkinson's drugs (excluding conventional laxatives, antidiarrheals, or intestinal stimulants; during the trial, participants are only allowed to take prescribed emergency medications, with detailed records of usage required);\n3. History of chronic pain or substance abuse, such as opioids;\n4. Diagnosed mental disorders with psychotropic medication use for over 3 months prior to the visit, or history of psychotropic or hormonal medication use for over 3 months;\n5. Individuals at risk of self-harm or suicide, as assessed by a psychiatrist, or those requiring psychosomatic intervention;\n6. History of allergy to psychiatric medications (e.g., fluoxetine), or contraindications to fluoxetine such as liver\u002Fkidney impairment or prolonged Q-T interval on ECG;\n7. Pregnant or breastfeeding women;\n8. Patients with benign or malignant tumors or autoimmune diseases;\n9. Chronic conditions requiring long-term medication that may affect quality of life or interfere with examinations\u002Ftreatment, including cardiovascular diseases, coagulation disorders or regular anticoagulant use (warfarin\u002Fheparin), liver\u002Fkidney diseases, organ failure, cognitive impairment, aphasia, etc.","80 Years",{"count":80,"type":21},60,[24],"The purpose of this randomized, double-blind, placebo-controlled trial is to evaluate the efficacy and safety of transcranial alternating current stimulation (tACS) in adults with refractory functional constipation comorbid with somatic symptom disorder. This population is characterized by persistent bowel dysfunction despite conventional treatments, frequent reliance on laxatives, and evidence of impaired brain-gut regulation contributing to chronic symptoms.\n\nThe study focuses on three primary domains:\n\nEfficacy - Bowel Function:\n\n• Assessment of whether a 4-week course of tACS improves bowel activity, measured by changes in Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency over the treatment and follow-up period.\n\nEfficacy - Symptom and Quality of Life Burden:\n\n• Evaluation of the effect of tACS on constipation-related severity and patient-reported outcomes, including the Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL).\n\nSafety and Tolerability:\n\n• Documentation of adverse events associated with tACS, with particular attention to incidence, intensity, and overall patient tolerability compared with sham stimulation.",[27,84,85],"Somatic Symptom Disorder (DSM-5)","Refractory Constipation",[87,88,89,90],"Functional Constipation","Somatic Symptom Disorder","refractory constipation","transcranial alternating current stimulation","2026-01-07",{"date":93,"type":36},"2026-01-09",{"date":95,"type":36},"2025-08-20",{"date":97,"type":21},"2026-12-01",{"name":99,"class":68},"Xijing Hospital of Digestive Diseases",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":52,"minAge":108,"maxAge":53,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":44},"100618820","combined-exercise-and-massage-program-in-children-with-functional-constipation-100618820","NCT07336589","COMBINED EXERCISE AND MASSAGE PROGRAM IN CHILDREN WITH FUNCTIONAL CONSTIPATION","THE EFFECTS OF A COMBINED EXERCISE TRAINING AND MASSAGE THERAPY IN CHILDREN WITH FUNCTIONAL CONSTIPATION","FC-EXMASS","Inclusion Criteria:\n\n* Children aged 5-18 years\n* Diagnosed with functional constipation according to Rome IV criteria\n* Voluntary participation with written informed consent obtained from parents or legal guardians\n\nExclusion Criteria:\n\n* Refusal to participate\n* Presence of congenital conditions (e.g., Down syndrome, Hirschsprung disease)\n* Endocrine or metabolic disorders (e.g., hypothyroidism, diabetes mellitus, diabetes insipidus)\n* Neurological or psychiatric disorders (e.g., spina bifida, cerebral palsy, autism spectrum disorders)\n* History of abdominal surgery within the last year\n* Presence of herniation or open wounds in the abdominal massage area","5 Years",{"count":110,"type":21},40,[24],"The goal of this clinical trial is to learn if a combined exercise and abdominal massage program improves bowel function and daily well-being in children with functional constipation. Researchers will compare this program with standard care by measuring bowel symptoms, rectal size, pelvic floor strength, trunk endurance, and quality of life.",[27],[115,116,117,118,119,120],"Children","Exercise Therapy","Abdominal Massage","Pelvic Floor","Non-pharmacological Treatment","Randomized Controlled Trial","2026-01-02",{"date":123,"type":36},"2026-01-13",{"date":125,"type":21},"2026-02",{"date":127,"type":21},"2026-05",{"name":129,"class":68},"Zeynep Idil Sevimli",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":4,"eligibilityCriteria":136,"healthyVolunteers":16,"sex":52,"minAge":53,"maxAge":54,"enrollmentInfo":137,"targetDuration":4,"studyType":22,"phases":139,"briefSummary":140,"conditions":141,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":44},"100590627","effects-of-probiotics-on-symptoms-of-constipation-in-adults-with-functional-constipation-100590627","NCT06969872","Effects of Probiotics on Symptoms of Constipation in Adults With Functional Constipation","The Effects of ABKefir on Functional Constipation in Subjects: a Randomized, Double-blind, Placebo-controlled Trial","Inclusion Criteria:\n\n* male or female\n* aged 18-75 years old\n* fulfill Rome IV criteria for functional constipation\n* have not participated in similar research in the past three months\n\nExclusion Criteria:\n\n* Personal or family history of colon cancer, celiac disease, and inflammatory bowel disease\n* Irritable bowel syndrome diagnosed during colonoscopy\n* Those who are pregnant recently (including men and women), or are pregnant or breastfeeding women.\n* Taking antidepressants, anti-anxiety drugs and other psychotropic drugs.\n* Long-term medication is required to improve constipation\n* Those diagnosed with myocardial infarction, cerebral infarction, malignant tumor and\u002For other serious diseases are not suitable for participating in the study.\n* Allergic symptoms to probiotics or any ingredients\n* Having a history of serious mental illness\n* Drug-related crimes or alcohol problems\n* Have recently traveled to areas where parasitic diseases are prevalent.",{"count":138,"type":21},165,[24],"The purpose of this study was to evaluate the efficacy of 1 capsules of ABKefir per day on symptoms of constipation in subjects with functional constipation by clinical trial.",[27],"2025-12-29",{"date":121,"type":36},{"date":145,"type":36},"2024-12-27",{"date":147,"type":21},"2026-09-30",{"name":149,"class":68},"Chung Shan Medical University",{"id":151,"slug":152,"hasResults":11,"nctId":153,"briefTitle":154,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":158,"enrollmentInfo":159,"targetDuration":4,"studyType":22,"phases":161,"briefSummary":164,"conditions":165,"keywords":166,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":170,"lastUpdatePostDateStruct":171,"startDateStruct":173,"completionDateStruct":175,"leadSponsor":177,"locationsCount":69},"100554980","phase-1-evaluation-of-fluoxetine-for-refractory-constipation-with-somatic-symptom-disorder-features-100554980","NCT06506136","Evaluation of Fluoxetine for Refractory Constipation With Somatic Symptom Disorder Features","Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Fluoxetine in Patients With Refractory Constipation Exhibiting Somatic Symptom Disorder Features","REFLECT","Participants in this study were recruited from a real-world outpatient constipation patient registry platform, which provides a comprehensive case database to support evidence-based research. Based on the characteristics of the primary target population identified in previous studies of fluoxetine, participants with refractory constipation were selected from the registry according to the following criteria:\n\nAll participants were required to meet the Rome IV diagnostic criteria for functional constipation.Specifically: 1) At least two of the following symptoms must be present during more than 25% of defecations: straining; lumpy or hard stools; sensation of incomplete evacuation; sensation of anorectal obstruction\u002Fblockage; manual maneuvers to facilitate defecation; fewer than three spontaneous bowel movements per week; 2) Loose stools are rarely present without the use of laxatives; 3) The criteria for IBS were not met.\n\nSymptoms must have been present for at least six months prior to diagnosis, with the diagnostic criteria fulfilled during the last three months. Participants who met the diagnostic criteria were further assessed against the inclusion and exclusion criteria outlined below. Patients who did not meet any inclusion criteria or met any exclusion criteria were not recruited.\n\nInclusion criteria\n\n1. Diagnosis of Functional Constipation (FC): Participants must meet the diagnostic criteria for functional constipation according to Rome IV criteria.\n2. Low CSBM Frequency: During the 2-week screening period, participants must experience Complete Spontaneous Bowel Movements (CSBM) ≤ 2 times per week.\n3. Unsatisfactory Previous Treatments: Participants must have been dissatisfied with previous treatments for functional constipation, having undergone at least 3 months of treatment, including laxatives or other prokinetic agents.\n4. Diagnosis of Somatic Symptom Disorder (SSD): Participants must meet the diagnostic criteria for Somatic Symptom Disorder (SSD) according to DSM-5. All participants will undergo a semi-structured clinical interview based on DSM-5 criteria, conducted by professionals trained in SSD diagnosis.\n\n   4.1. Criterion A: One or more physical symptoms that cause significant discomfort and\u002For disruption in daily life.\n\n   4.2. Criterion B: At least one of the following: 1) Excessive and persistent thoughts about the severity of symptoms. 2) Persistent high anxiety about health or symptoms. 3) Excessive time and energy spent on health concerns or symptoms.\n\n   4.3. Criterion C: The symptoms have persisted for at least 6 months.\n5. Age Range: Participants must be between the ages of 18 and 60 years.\n6. Not Participating in Other Ongoing Trials: Participants must not be involved in any other clinical trials during the study period.\n7. Informed Consent: Participants must voluntarily agree to participate in the study and sign an informed consent form.\n\nExclusion criteria\n\n1. Organic Diseases: Participants with organic diseases (e.g., tuberculosis, Crohn's disease, tumors, congenital megacolon), endocrine disorders (e.g., hypothyroidism), metabolic diseases (e.g., diabetes, thyroid dysfunction), or neurological disorders (e.g., Parkinson's disease).\n2. Use of Medications Affecting Bowel Function: Participants who require long-term use of medications that may affect bowel function or induce constipation, such as Parkinson's medications, except for routine laxatives, antidiarrheal agents, and intestinal stimulants. Note: During the trial, participants are only allowed to use the specified emergency medications, and all medication use must be carefully recorded.\n3. Chronic Pain or Substance Abuse: Participants with a history of chronic pain lasting more than 6 months or with a pain score ≥4 (based on the visual analog scale), or a history of substance abuse.\n4. Mental Health Disorders: Participants diagnosed with psychiatric disorders before the study and continuously using psychiatric medications for more than 3 months, or those with a history of using psychiatric medications and\u002For corticosteroids for more than 3 months before the study.\n5. Self-harm or Suicide Risk: Participants with a risk of self-harm or suicide, as assessed by a psychologist, or those requiring psychophysical interventions.\n6. Allergic Reactions or Contraindications to Psychiatric Medications: Participants with a history of allergy to psychiatric medications, including fluoxetine, or those with liver or kidney dysfunction, or any contraindications for fluoxetine, such as prolonged QT interval on ECG.\n7. Pregnant or Breastfeeding Women: Pregnant or breastfeeding women.\n8. Other Malignant or Benign Tumors: Participants with other malignant or benign tumors or autoimmune diseases.\n9. Chronic Diseases Impacting Life Quality: Participants with cardiovascular diseases, clotting disorders (e.g., those on long-term warfarin or heparin therapy), liver or kidney diseases, organ failure, cognitive disorders, aphasia, or any other chronic diseases requiring long-term medication, which may significantly affect their quality of life and the evaluation of treatment outcomes.","60 Years",{"count":160,"type":21},194,[162,163],"PHASE1","PHASE2","The purpose of this randomized, double-blind, placebo-controlled trial is to determine whether fluoxetine is effective and safe for adults with refractory constipation that exhibits Somatic Symptom Disorder (SSD) features-namely, persistent preoccupation with bowel function, heightened perception of defecatory discomfort, and clinically significant somatic symptom burden (PHQ-15 ≥ 10) in the absence of IBS-C abdominal pain criteria.\n\nThe study will address three primary questions:\n\nEfficacy-Bowel Function:\n\n• Does 12 weeks of fluoxetine increase Complete Spontaneous Bowel Movements (CSBM) and overall bowel-movement frequency compared with placebo?\n\nEfficacy-Somatic Symptom Burden:\n\n• Does fluoxetine reduce SSD severity, as measured by the Patient Health Questionnaire-15 (PHQ-15) and the Somatic Symptom Scale-8 (SSS-8)?\n\nSafety and Tolerability:\n\n• What adverse events occur during fluoxetine treatment, and how do their incidence and intensity compare with placebo?",[85,84,27],[89,167,168,169],"fluoxetine","somatic symptom disorder","functional constipation","2025-08-03",{"date":172,"type":36},"2025-08-06",{"date":174,"type":21},"2025-09-01",{"date":176,"type":21},"2027-05-30",{"name":178,"class":68},"Zhifeng Zhao, PhD",{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":186,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":192,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":44},"100599298","the-beneficial-effect-on-the-bowel-function-of-a-food-supplement-based-on-sea-buckthorn-hippophae-rhamnoides-l-extract-in-subjects-with-primary-functional-constipation-100599298","NCT07082673","The Beneficial Effect on the Bowel Function of a Food Supplement Based on Sea Buckthorn (Hippophae Rhamnoides L.) Extract in Subjects With Primary Functional Constipation","Efficacy and Tolerability of a Food Supplement Based on a Sea Buckthorn (Hippophae Rhamnoides L.) Extract Taken at Two Different Doses for the Management of Balance in Bowel Function in Subjects With Primary Functional Constipation: Single-center, Randomized, Placebo-controlled, Parallel-arm, Double-blind Clinical Trial","Inclusion Criteria:\n\n* aged between 18 and 70 years\n* able to understand and sign informed consent\n* HIV negative test\n* negative pregnancy test\n* with symptoms of chronic constipation for at least 3 months (with onset at least 6 months earlier)\n* absent\u002Fnon-predominant abdominal pain that occurs less than one day per week and, therefore, not affected by IBS-C\n* who have less than three SCBWs per week and at least one of the following conditions:\n\n  * in more than 25%\\* of defecatory acts\n  * lumpy or hard stools (BSFS type 1 or 2) in more than 25% of bowel movements\n  * feeling of incomplete evacuation in more than 25% of defecations\n  * feeling of anorectal obstruction\u002Fblockage in more than 25% of defecations\n  * carry out manual manoeuvres to facilitate evacuation in more than 25% of defecations\n* able to understand and comply with the requirements of the protocol\n\nExclusion Criteria:\n\n* pregnancy\n* lactation\n* HIV positive\n* do not meet inclusion criteria.","70 Years",{"count":188,"type":21},135,[24],"The study will aim to evaluate the efficacy and tolerability of a supplementation with Sea Buckthorn (Hippophae rhamnoides L.) at two different dosages for the management of the balance of intestinal function in subjects with primary functional constipation.\n\nThe primary outcome is the improvement of the frequency of bowel movements (SCBM) in subjects with functional constipation; then the secondary outcomes are the 1) improvement in stool consistency, assessed through the Bristol Stool Form Scale (BSFS) and 2) reduction in the typical symptoms of constipation, such as feeling of bloating and abdominal distension, feeling of heaviness, abdominal pain and flatulence, improving the quality of life of the subjects affected by primary functional constipation.",[27],[193,194,195,196],"Functional constipation","Food supplement","sea buckthorn","Hippophae rhamnoides L.","2025-07-25",{"date":199,"type":36},"2025-07-30",{"date":201,"type":36},"2025-07-24",{"date":203,"type":21},"2025-09",{"name":205,"class":43},"ISTITUTO FARMOCHIMICO FITOTERAPICO: EPO SRL",{"id":207,"slug":208,"hasResults":11,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":4,"eligibilityCriteria":212,"healthyVolunteers":11,"sex":52,"minAge":213,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":22,"phases":216,"briefSummary":217,"conditions":218,"keywords":219,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":228,"lastUpdatePostDateStruct":229,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":4},"100589546","gutproh-probiotic-herbal-formula-for-self-reported-constipation-in-community-adults-100589546","NCT06955819","GUTPROH: Probiotic-Herbal Formula for Self-Reported Constipation in Community Adults","GUTPROH Trial: A Double-Blind, Randomized, Placebo-Controlled Study of Probiotic-Multiherb Formula for Self-Reported Constipation Symptoms in Community-Dwelling Adults","Inclusion Criteria:\n\n* Aged 35 years or older.\n* Self - reported good comprehensive physical health status. Have complaints of irregular bowel movement frequency and a need for improved defecation, or have a spontaneous defecation frequency of less than 3 times per week in the 2 weeks before administration, or meet two or more of the following Rome IV criteria for functional constipation (FC): ① \\>25% of defecations are difficult; ② \\>25% of defecations are dry, hard, or pellet - shaped; ③ \\>25% of defecations have a sense of incomplete evacuation; ④ \\>25% of defecations have a feeling of anorectal obstruction or blockage; ⑤ \\>25% of defecations require manual assistance; ⑥ Fewer than 3 spontaneous defecations per week.\n* Provide written informed consent voluntarily before the study and be able to fill out the subject log card and research questionnaire as required by the trial protocol.\n\nExclusion Criteria:\n\n* Frail elderly people with a score of ≥3 on the FRAIL Frailty Screening Scale.\n* Self - reported presence of loose stools.\n* Those who have undergone surgery within 30 days, had an acute gastrointestinal disease within 30 days, or have been diagnosed with severe organic diseases causing defecation difficulties (such as colon cancer, intestinal obstruction, inflammatory bowel disease, etc.).\n* Patients with severe systemic diseases in the acute phase of cardiovascular, liver, kidney, and hematopoietic systems.\n* Patients with symptoms of yin deficiency and internal heat, such as dry mouth, night sweats, restlessness of the five centers (palms, soles, and chest), hard and dry stools with bad breath, red tongue with yellow coating.\n* Those who have taken antibiotics within 30 days before the start of the trial.\n* Those who have taken probiotics, fermented products, other laxative drugs, or health supplements within 14 days before the start of the trial (i.e., during the wash - out period).\n* Those who have not signed the informed consent form. Other situations considered unsuitable for enrollment by the researchers.","35 Years",{"count":215,"type":21},300,[24],"The goal of this clinical trial is to evaluate the effects of probiotic combined with or without herbal powder on relieving constipation and improving the gut microbiota in community - dwelling people with a demand for improved bowel movements through human feeding trials, and to explore their potential mechanisms of action.\n\nThe main research questions are as follows:\n\nCan the probiotic combined with or without herbal powder significantly increase the frequency of defecation in subjects, and at the same time improve fecal characteristics and defecation conditions? Can the the probiotic combined with or without herbal powder regulate the gut microbiota? What are the biological mechanisms by which the probiotic combined with or without herbal powder improve constipation and gut microbiota function? Researchers will compare experimental group 1 (taking the compound probiotic combined with herbal powder), experimental group 2 (taking probiotics alone) with the placebo control group (taking an identical - looking blank matrix powder) to observe their effects on defecation and the gut microbiota.\n\nThe main tasks for participants include:\n\nTaking the compound probiotic combined with herbal powder (experimental group 1), probiotics alone (experimental group 2), or blank matrix powder (placebo control group) as required for 12 weeks.\n\nRecording daily defecation frequency, defecation conditions, fecal characteristics, and daily diet, and reporting any adverse reactions.\n\nLongitudinal monitoring employs serial assessments comprising: 1) physical examinations (mental status\u002Fvital signs); 2) laboratory diagnostics (hematology\u002Furinalysis\u002Ffecal routine tests, hepatic-renal-metabolic panels); 3) ECG and abdominal ultrasonography; and 4) advanced analyses (gut microbiome sequencing and serum metabolomic profiling via LC\u002FMS\u002FMS).",[27],[220,221,193,222,223,224,225,226,227],"Probiotic","Herbal powder","Gut microbiota","Randomized controlled trial","Placebo control","Community population","Efficacy evaluation","Mechanism exploration","2025-06-23",{"date":230,"type":36},"2025-06-26",{"date":232,"type":21},"2025-07-10",{"date":234,"type":21},"2025-12-31",{"name":236,"class":237},"Beijing Hospital","OTHER_GOV",{"id":239,"slug":240,"hasResults":11,"nctId":241,"briefTitle":242,"officialTitle":243,"acronym":4,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":245,"targetDuration":4,"studyType":22,"phases":247,"briefSummary":248,"conditions":249,"keywords":250,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100593740","baliao-acupoint-stimulation-totreat-functional-constipation-100593740","NCT07010367","Baliao Acupoint Stimulation toTreat Functional Constipation","Effects and Mechanism of Baliao Acupoint Stimulation (BL31~BL34) for Functional Constipation","Inclusion Criteria:\n\n* Age:18 years or older.\n* Diagnosed with functional constipation according to the Rome IV criteria.\n* The participant has not received any treatment for functional constipation in the past two weeks (except for emergency interventions).\n* Right-handed.\n* Signed a written informed consent form to participate in this study.\n\nExclusion Criteria:\n\n* Presence of organic constipation, drug-induced constipation, or systemic constipation.\n* Presence of metallic foreign bodies in the body, pacemakers, or other contraindications for MRI examination.\n* Communication disorders or unwillingness to cooperate with treatment.",{"count":246,"type":21},36,[24],"This study is a randomized controlled trial that explores how a specific acupuncture treatment might help people with functional constipation. The investigators are testing the idea that a treatment called \"acupuncture at the Baliao acupoints\" could work by changing the way certain parts of the brain connect and function. These brain changes might help improve gut function and relieve constipation symptoms.\n\nThe investigators will work with people who have functional constipation. Some participants will receive the real Baliao acupoint thread embedding, while others will get a sham acupuncture as a comparison. Using special brain imaging techniques, the investigators will look at how the brain's connections and structures change. The investigators will also track how often participants have bowel movements, the consistency of their stools, and their overall symptoms and quality of life. By comparing these results, the investigators hope to understand how the Baliao acupoint treatment works and why it might be effective for constipation.",[27],[169,251],"fMRI","2025-06-06",{"date":254,"type":36},"2025-06-08",{"date":256,"type":21},"2025-06-20",{"date":258,"type":21},"2026-07-30",{"name":260,"class":68},"Affiliated Hospital of Nanjing University of Chinese Medicine",{"id":262,"slug":263,"hasResults":11,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":267,"eligibilityCriteria":268,"healthyVolunteers":11,"sex":52,"minAge":269,"maxAge":53,"enrollmentInfo":270,"targetDuration":4,"studyType":22,"phases":272,"briefSummary":273,"conditions":274,"keywords":275,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":285,"leadSponsor":287,"locationsCount":4},"100580366","acupuncture-for-children-with-functional-constipation-100580366","NCT06836362","Acupuncture for Children with Functional Constipation","Acupuncture for Children with Functional Constipation: a Pilot Study","ACU-PILOT","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n* 6-18 years of age\n* meet the modified Rome IV criteria for FC (defined as meeting at least two of the following criteria during the 2-week run-in period despite receiving treatment with PEG with a minimum dose of 0.2 g\u002Fkg\u002Fday):\n\n  1. Two or fewer spontaneous bowel movements (SBMs) per week (an SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use in the preceding 24 hours)\n  2. History of excessive stool retention\n  3. History of painful or hard bowel movements\n  4. History of large-diameter stools\n  5. Presence of a large fecal mass in the rectum\n  6. At least 1 episode\u002Fweek of incontinence after the acquisition of toileting skills\n  7. History of large-diameter stools that may obstruct the toilet in toilet-trained children\n* Insufficient symptom management despite at least three months of medical management (including education, non-pharmacological advice and laxatives) by a physician. Insufficient symptom management is defined as the presence of at least one of the Rome IV criteria for FC despite medical management by a physician.\n* are treated with PEG with a minimum dose of 0.2 g\u002Fkg\u002Fday for a minimum of 1 month prior to inclusion in the study\n* Written informed consent obtained from parents or guardians and all children ≥12 years.\n\nExclusion Criteria:\n\n* A potential subject who meets any of the following criteria will be excluded from participation in this study:\n* children with FC not treated with PEG with a minimum dose of 0.2g\u002Fkg\u002Fday during at least one month at the time of potential inclusion.\n* Irritable bowel syndrome.\n* Organic causes of constipation; e.g. celiac disease, pediatric intestinal pseudo-obstruction, hypothyroidism, spina bifida, anorectal malformations, or Hirschsprung disease.\n* Significant chronic health conditions requiring specialty care (e.g. cardiac, pulmonary, hepatic, hematopoietic, renal, endocrine, or metabolic diseases, sickle cell disease, cerebral palsy) that could potentially impact the child's ability to participate or confound the results of the study.\n* Unintentional weight loss greater than or equal to 5% of their body weight within the last 3 months.\n* Gastrointestinal blood loss.\n* Recurrent or unexplained fevers.\n* Pregnancy.\n* Smoking.\n* History of abdominal surgery involving the luminal gastrointestinal tract, except appendectomy or hernia repairs.\n* Concomitant use of drugs that are known to affect gastrointestinal motility.\n* Established diagnoses of autism spectrum disorders.\n* Major psychiatric disorders (bipolar disorder, schizophrenia, major depression) or a history of abuse.\n* Severe needle-related anxiety.\n* Rash or active local infection over an acupuncture point.\n* Immunocompromised children (specifically inadequately regulated diabetes mellitus, active staphylococcal-related skin conditions)\n* Clotting disorders or a recent history of thrombocytopenia.\n* Children who previously received acupuncture for constipation.\n* Children who currently participate in another clinical trial.","6 Years",{"count":271,"type":21},18,[24],"Background of the study:\n\nFunctional constipation (FC) is common in children and poses a significant burden to patients, their families and the healthcare system. Pharmacological treatment mainly consists of oral osmotic laxatives. However, poor adherence to oral laxatives is known to be a common problem and patients often remain symptomatic despite pharmacological treatment. Many parents seek help in the form of complementary and integrative medicine. Acupuncture has been shown to relieve symptoms in adults with FC. However, published studies in children with FC are scarce and have important limitations.\n\nObjective of the study:\n\nTo evaluate the feasibility, safety and potential efficacy of acupuncture in children with FC. The results of this study will be used to design a future randomized controlled trial (RCT).\n\nStudy design:\n\nA prospective, non-randomized, multicenter, open-label pilot study.\n\nIntervention: Children will receive 8 acupuncture sessions during 10 weeks (1 session per week during 6 weeks, followed by 1 session every other week during 4 weeks). Concurrent pharmacological treatment with polyethylene glycol ≥ 0.2 g\u002Fkg\u002Fday will be maintained as initiated prior to participation in the study.\n\nStudy population:\n\n18 children (6-18 years old) with FC according to the Rome IV criteria.",[27],[169,276,277,278,279,280],"child","acupuncture","children","DGBI","pilot study","2025-02-18",{"date":283,"type":36},"2025-02-20",{"date":283,"type":21},{"date":286,"type":21},"2026-10",{"name":288,"class":68},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":290,"slug":291,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":4,"eligibilityCriteria":294,"healthyVolunteers":11,"sex":17,"minAge":53,"maxAge":295,"enrollmentInfo":296,"targetDuration":4,"studyType":22,"phases":297,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":300,"lastUpdatePostDateStruct":301,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":69},"100577726","effect-of-lactobacillus-dsm17938-on-functional-constipation-and-intestinal-flora-in-pregnant-women-100577726","NCT06802042","Effect of Lactobacillus DSM17938+ on Functional Constipation and Intestinal Flora in Pregnant Women","Inclusion Criteria:\n\n* (1) Pregnant women, age ≥18 years and \\\u003C40 years old, and gestational age \\\u003C28 weeks; (2) Must meet two or more of the following symptoms (Refer to the Roman IV standard):\n\n  * It is difficult to defecate at least 25% of the time;\n\n    * It is lumpy or hard stool at least 25% of the time;\n\n      * It is not enough to defecate at least 25% of the time;\n\n        * It is at least 25% of the time that there is anorectal obstruction or obstruction in defecation;\n\n          * It requires manual assistance at least 25% of the time;\n\n            ⑥It is spontaneous defecation less than 3 times a week. At the same time, loose stools rarely occur when no laxatives are used, which does not meet the diagnostic criteria of irritable bowel syndrome (IBS). The symptoms in the past 2 weeks have met the above diagnostic criteria.\n\n            (3) Pregnant women receive and follow high-protein and high-fiber dietary guidance during the first trimester.\n\n            (4) There were no other complications. (5) No medication was used to interfere with constipation symptoms.\n\nExclusion Criteria:\n\n* (1) Non-pregnant women, age \\\u003C18 years or ≥40 years old, and gestational age ≥28 weeks; (2) Constipation caused by intestinal and systemic organic factors, drugs and other reasons, or concurrent with other non-constipation intestinal diseases; (3) History of use of antibiotics, probiotics, prebiotics, etc. in the past 2 weeks; (4) Pregnant women with thyroid disease, diabetes, hypertension, obesity, overweight or any metabolic disease.","40 Years",{"count":110,"type":21},[24],"Constipation (constipation) is a common clinical symptom, including difficulty in defecation and \u002F or reduced frequency of defecation, dry and hard stool, difficulty in defecation, feeling of inexhaustible defecation, feeling of anorectal obstruction, time-consuming defecation and need for auxiliary defecation. Reduced defecation means defecation less than 3 times a week.Constipation is very common during pregnancy, and studies have found that the incidence of constipation in pregnant women is as high as 40%. Among them, the prevalence of functional constipation in the early, middle, late and postpartum pregnancies is 35%, 39%, 21% and 17% respectively, with the highest in the early and middle pregnancies.Constipation can increase the psychological burden of pregnant women and affect their quality of life. Long-term severe constipation can also induce or aggravate hemorrhoids. Severe constipation can induce uterine contractions, which will adversely affect the pregnancy outcome of pregnant women.Studies have found that there is a difference in the abundance of intestinal flora between patients with constipation during pregnancy and pregnant women without digestive tract diseases.Although microecological preparations are not front-line drugs for the treatment of chronic constipation, they can promote intestinal peristalsis and the recovery of gastrointestinal motility by regulating the imbalance of intestinal flora. More and more researchers recommend them as long-term adjuvant drugs for chronic constipation. Probiotics are a type of microecological preparation, which refers to living microorganisms that can have beneficial health effects on the host after ingesting a sufficient amount.It is relatively safe to supplement probiotics during pregnancy.Our research team found a probiotic strain, Lactobacillus reuteri DSM17938+, which has no significant difference in improving constipation symptoms in patients with constipation compared with lactulose, and is even more effective than lactulose in alleviating abdominal pain and flatulence symptoms.However, clinical studies proving that Lactobacillus reuteri DSM17938 + is effective on constipation are generally concentrated abroad, and mainly focus on infants and young children, children, adults\\] or intestinal colic. Data on maternal population in China is lacking.",[27],"2025-01-25",{"date":302,"type":36},"2025-01-30",{"date":304,"type":36},"2025-01-09",{"date":306,"type":21},"2026-12-31",{"name":308,"class":68},"Peking Union Medical College Hospital"]