[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"refractory-constipation\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:refractory-constipation":25},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,39,69,100,128],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":28,"startDateStruct":31,"completionDateStruct":33,"leadSponsor":35,"locationsCount":38},"100619421","optimization-of-tavns-intervention-strategies-for-refractory-constipation-100619421",false,"NCT07344402","Optimization of taVNS Intervention Strategies for Refractory Constipation","A Prospective, Randomized, Controlled Trial Investigating Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) Intervention Strategies and Neurophysiological Mechanisms in Patients With Refractory Constipation","Inclusion Criteria (Revised) Diagnosis of Functional Constipation (FC): Meets Rome IV criteria for functional constipation.\n\nLow CSBM frequency during screening: During the 2-week screening\u002Frun-in period, has ≤2 complete spontaneous bowel movements (CSBMs) per week, based on daily diary.\n\nInadequate response to prior therapy: History of ≥3 months of prior constipation treatment (e.g., laxatives and\u002For prokinetic agents) with inadequate response (persistent constipation symptoms and\u002For persistently low CSBM frequency) as documented by medical history and\u002For records.\n\nAge: 18 to 80 years. Ability to comply: Able and willing to comply with study procedures (including stimulation sessions and diary completion).\n\nNo concurrent clinical trial participation: Not participating in another interventional clinical trial during the study period.\n\nInformed consent: Provides written informed consent. Exclusion Criteria (Revised) Organic\u002Fsecondary causes of constipation: Evidence or history of gastrointestinal organic disease (e.g., inflammatory bowel disease, colorectal tumor, congenital megacolon) or other conditions likely to cause secondary constipation, including endocrine\u002Fmetabolic disorders (e.g., uncontrolled hypothyroidism, uncontrolled diabetes) or neurological disorders (e.g., Parkinson's disease, spinal cord disorders).\n\nMedications causing constipation (unless stable): Current use of medications known to cause constipation (e.g., opioids, anticholinergics) that cannot be discontinued or kept stable during the study, in the investigator's judgment.\n\nOpioid use disorder or chronic opioid use: History of substance abuse or chronic opioid use that may affect bowel function.\n\nSevere psychiatric conditions or safety risk: Current severe psychiatric disorder requiring urgent intervention, or risk of self-harm\u002Fsuicide as assessed by a qualified clinician.\n\nContraindications to taVNS or ear stimulation: Significant ear disease or skin lesions\u002Finfection at the stimulation site, or other contraindications to the study device\u002Fprocedure.\n\nImplanted electronic medical devices: Presence of implanted electrical devices (e.g., pacemaker, implantable cardioverter-defibrillator) or other conditions where electrical stimulation is contraindicated.\n\nPregnancy or lactation: Pregnant or breastfeeding women. Serious comorbidities that may interfere: Severe or unstable medical conditions that could interfere with participation or outcome assessment (e.g., significant cardiovascular disease\u002Farrhythmia, coagulation disorders or regular anticoagulant therapy, severe hepatic\u002Frenal impairment, organ failure).\n\nCognitive\u002Fcommunication impairment: Cognitive impairment, aphasia, or other conditions preventing valid consent or reliable diary completion.\n\nInvestigator discretion: Any condition that, in the investigator's opinion, makes the participant unsuitable for the study.","ALL",{"count":18,"type":19},100,"ESTIMATED","INTERVENTIONAL",[22],"NA","The goal of this clinical trial is to learn whether transcutaneous auricular vagus nerve stimulation (taVNS) works to treat refractory constipation in adults. It will also learn about the safety and tolerability of taVNS. The main questions it aims to answer are:\n\nDoes taVNS improve constipation symptoms, as measured by the change in complete spontaneous bowel movements per week (ΔCSBMs\u002Fweek) from baseline to post-treatment? What medical problems or side effects do participants have when receiving taVNS? Does taVNS reduce the need for rescue laxatives? Researchers will compare active taVNS to sham taVNS to see if taVNS works to treat refractory constipation.\n\nParticipants will:\n\nBe randomly assigned (double-blind) to receive active taVNS or sham taVNS for 20 days Receive stimulation twice daily, 30 minutes per session, with a 12-hour interval between sessions Receive stimulation at 30 Hz with 200 μs pulse width, delivered to the left cymba conchae Keep a daily diary of bowel habits and symptoms, including CSBMs, and rescue laxative use (bowel movements occurring within 24 hours after rescue laxative use will not be counted as CSBMs)",[25],"Refractory Constipation","RECRUITING","2026-01-07",{"date":29,"type":30},"2026-01-15","ACTUAL",{"date":32,"type":30},"2025-09-01",{"date":34,"type":19},"2026-01-20",{"name":36,"class":37},"Xijing Hospital of Digestive Diseases","OTHER",1,{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":45,"eligibilityCriteria":46,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":48,"enrollmentInfo":49,"targetDuration":4,"studyType":20,"phases":51,"briefSummary":52,"conditions":53,"keywords":56,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":27,"lastUpdatePostDateStruct":61,"startDateStruct":63,"completionDateStruct":65,"leadSponsor":67,"locationsCount":68},"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.","18 Years","80 Years",{"count":50,"type":19},60,[22],"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.",[54,55,25],"Functional Constipation (FC)","Somatic Symptom Disorder (DSM-5)",[57,58,59,60],"Functional Constipation","Somatic Symptom Disorder","refractory constipation","transcranial alternating current stimulation",{"date":62,"type":30},"2026-01-09",{"date":64,"type":30},"2025-08-20",{"date":66,"type":19},"2026-12-01",{"name":36,"class":37},2,{"id":70,"slug":71,"hasResults":11,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":4,"eligibilityCriteria":75,"healthyVolunteers":11,"sex":16,"minAge":76,"maxAge":47,"enrollmentInfo":77,"targetDuration":4,"studyType":20,"phases":79,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":38},"100615365","the-role-of-anorectal-manometry-in-pediatric-chronic-refractory-constipation-100615365","NCT07291661","The Role of Anorectal Manometry in Pediatric Chronic Refractory Constipation","The Role of Anorectal Manometry in Diagnosing and Guiding Management of Pediatric Chronic Refractory Constipation","Inclusion Criteria:\n\n1. Children and adolescents aged from 4 to 18 years.\n2. Participants who have chronic refractory constipation either functional or organic with or without fecal incontinence.\n3. Cooperative patients.\n\nExclusion Criteria:\n\n1. Children aged less than 4 years old.\n2. Uncooperative patients.\n3. Children with anal fissures or any painful conditions that interfere with the procedure.","4 Years",{"count":78,"type":19},54,[22],"This research protocol outlines a two-year descriptive cross-sectional study to investigate the role of high-resolution anorectal manometry (HRAM) in children aged 4-18 years with chronic refractory constipation.The study plans to enroll 54 patients at Ain Shams University Specialized Hospital . The study aims to identify different patterns of anorectal dysfunction (like dyssynergic defecation or rectal hyposensitivity) using standardized international protocols. A key goal is to determine if these manometry findings can directly guide specific management strategies, such as biofeedback therapy for dyssynergia or botulinum toxin injections for anal hypertension. improving outcomes for children who do not respond to standard constipation therapies.",[25,82],"Fecal Incontinence in Children",[84,85,86,87,88,89],"Anorectal manometry","Functional constipation","Pediatric chronic refractory constipation","Fecal incontinence","Biofeedback therapy","Botox injection","NOT_YET_RECRUITING","2025-12-05",{"date":93,"type":30},"2025-12-18",{"date":95,"type":19},"2026-01-01",{"date":97,"type":19},"2027-12-31",{"name":99,"class":37},"Assiut University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":106,"eligibilityCriteria":107,"healthyVolunteers":11,"sex":16,"minAge":47,"maxAge":108,"enrollmentInfo":109,"targetDuration":4,"studyType":20,"phases":111,"briefSummary":114,"conditions":115,"keywords":116,"overallStatus":90,"whyStopped":4,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":123,"completionDateStruct":124,"leadSponsor":126,"locationsCount":68},"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":110,"type":19},194,[112,113],"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?",[25,55,54],[59,117,118,119],"fluoxetine","somatic symptom disorder","functional constipation","2025-08-03",{"date":122,"type":30},"2025-08-06",{"date":32,"type":19},{"date":125,"type":19},"2027-05-30",{"name":127,"class":37},"Zhifeng Zhao, PhD",{"id":129,"slug":130,"hasResults":11,"nctId":131,"briefTitle":132,"officialTitle":133,"acronym":4,"eligibilityCriteria":134,"healthyVolunteers":135,"sex":16,"minAge":47,"maxAge":136,"enrollmentInfo":137,"targetDuration":4,"studyType":139,"phases":4,"briefSummary":140,"conditions":141,"keywords":149,"overallStatus":26,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":159},"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",true,"45 Years",{"count":138,"type":19},150,"OBSERVATIONAL","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.",[142,25,143,144,145,146,147,148],"Constipation - Functional","Fluoxetine","fMRI","Brain Connectivity","Treatment Efficacy","Somatic Symptom","Mental Symptom",[144,150,59],"functional connectivity","2025-07-22",{"date":153,"type":30},"2025-07-24",{"date":155,"type":30},"2023-11-01",{"date":157,"type":19},"2026-09-01",{"name":36,"class":37},3]