Ignite Creation Date:
2025-12-25 @ 2:33 AM
Ignite Modification Date:
2025-12-30 @ 9:45 AM
Study NCT ID:
NCT01373034
Status:
UNKNOWN
Last Update Posted:
2011-06-14
First Post:
2011-06-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 36}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-06-13', 'studyFirstSubmitDate': '2011-06-13', 'studyFirstSubmitQcDate': '2011-06-13', 'lastUpdatePostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sum of irritable bowel syndrome symptom score', 'timeFrame': 'after 4 weeks', 'description': 'abdominal pain / abdominal discomfort urgency tenesmus abdominal distension'}], 'secondaryOutcomes': [{'measure': 'irritable bowel syndrome symptom score', 'timeFrame': 'after 2 weeks and 4 weeks', 'description': 'abdominal pain / abdominal discomfort urgency tenesmus abdominal distension'}, {'measure': 'Stool frequency and form', 'timeFrame': 'after 2 weeks and 4 weeks', 'description': 'Stool frequency (greater than 3 bowel movements/day or less than 3 bowel movements/week) Stool form (lumpy / hard or loose / watery stool)'}, {'measure': 'Symptom control of irritable bowel syndrome', 'timeFrame': 'after 2 weeks and 4 weeks'}, {'measure': 'Improvement of overall symptom in patient with irritable bowel syndrome', 'timeFrame': 'after 2 weeks and 4 weeks'}, {'measure': 'Severity of overall symptom in patient with irritable bowel syndrome', 'timeFrame': 'after 2 weeks and 4 weeks'}, {'measure': 'Severity of diarrhea', 'timeFrame': 'after 2 weeks and 4 weeks'}, {'measure': 'Assessment for quality of life related with irritable bowel syndrome', 'timeFrame': 'after 2 weeks and 4 weeks'}, {'measure': 'Assessment for patient satisfaction after administration completion', 'timeFrame': 'after 2 weeks and 4 weeks', 'description': 'Overall satisfaction for treatment Whether the patient will keep up treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diarrhea Predominant Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators will evaluate the efficacy of soy dietary fiber in adults with diarrhea predominant irritable bowel syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* willing to consent/undergo necessary procedures\n* between the age of 19 and 75 years\n* diarrhea predominant irritable bowel syndrome (satisfied with Rome II criteria)\n\nExclusion Criteria:\n\n* uncontrolled hypertension (Blood pressure \\> 170/100 mmHg)\n* uncontrolled diabetes mellitus (FBS \\> 180 mg/dL)\n* malignancy, cerebrovascular disease, cardiovascular disease\n* history of abdominal surgery except appendectomy and hernia repair\n* inflammatory bowel disease\n* clinically or laboratory-confirmed gastroenteritis\n* the use of motility drug or dietary fiber supplement in 2 weeks\n* allergy to soy fiber\n* serum Cr \\> 2 x Upper normal limit\n* AST or ALT \\> 2 x Upper normal limit\n* Pregnancy, Lactating woman'}, 'identificationModule': {'nctId': 'NCT01373034', 'briefTitle': 'The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effects of Soy Dietary Fiber in Adults With Diarrhea Predominant Irritable Bowel Syndrome: Double-blind, Randomized, Placebo-controlled, Cross Over Clinical Trial', 'orgStudyIdInfo': {'id': 'CHUNG_SOY'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soy Dietary Fiber', 'interventionNames': ['Dietary Supplement: Soy Dietary Fiber']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Rice powder', 'interventionNames': ['Dietary Supplement: Rice powder']}], 'interventions': [{'name': 'Soy Dietary Fiber', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Soy Dietary Fiber, Once a day, before meal, 1 pack(20g), per oral with water 90mL', 'armGroupLabels': ['Soy Dietary Fiber']}, {'name': 'Rice powder', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Rice powder, Once a day, before meal, 1 pack(20g), per oral with water 90mL', 'armGroupLabels': ['Rice powder']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'contacts': [{'name': 'Joo Sung Kim, M.D., PhD', 'role': 'CONTACT', 'email': 'jooskim@snu.ac.kr', 'phone': '+82-2-740-8112'}, {'name': 'Kyoung Sup Hong, M.D.', 'role': 'CONTACT', 'email': 'kshong1@empas.com', 'phone': '+82-10-2578-5738'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Joo Sung Kim, M.D., PhD', 'role': 'CONTACT', 'email': 'jooskim@snu.ac.kr', 'phone': '+82-2-740-8112'}, {'name': 'Kyoung Sup Hong, M.D.', 'role': 'CONTACT', 'email': 'kshong1@empas.com', 'phone': '+82-10-2578-5738'}], 'overallOfficials': [{'name': 'Joo Sung Kim, M.D., PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Seoul National University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kyoung Sup Hong', 'oldOrganization': 'Seoul National University Hospital'}}}}