Ignite Creation Date:
2025-12-24 @ 12:56 PM
Ignite Modification Date:
2025-12-27 @ 9:34 PM
Study NCT ID:
NCT03174561
Status:
UNKNOWN
Last Update Posted:
2017-06-02
First Post:
2017-05-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Inuline Supplement in Patients With Irritable Bowel Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D043183', 'term': 'Irritable Bowel Syndrome'}], 'ancestors': [{'id': 'D003109', 'term': 'Colonic Diseases, Functional'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002794', 'term': 'Choline'}, {'id': 'D012838', 'term': 'Silymarin'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D044947', 'term': 'Flavonolignans'}, {'id': 'D005419', 'term': 'Flavonoids'}, {'id': 'D002867', 'term': 'Chromones'}, {'id': 'D001578', 'term': 'Benzopyrans'}, {'id': 'D011714', 'term': 'Pyrans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2018-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-06-01', 'studyFirstSubmitDate': '2017-05-31', 'studyFirstSubmitQcDate': '2017-06-01', 'lastUpdatePostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IBS symptoms severity score', 'timeFrame': 'the last 10 days', 'description': 'visual analogue scale for IBS symptoms severity will be used'}, {'measure': 'number of bowel movements', 'timeFrame': 'the last 7 days', 'description': 'number of bowel movements/week'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Irritable Bowel Syndrome']}, 'descriptionModule': {'briefSummary': 'The study investigate the efficacy of the combination inuline, choline and silymarin in alleviating the symptomatology of the patients with irritable bowel syndrome with constipation in a randomized, cross-over, no treatment controlled study.', 'detailedDescription': 'In this study patients diagnosed using Rome IV criteria with irritable bowel syndrome with constipation are included. The study was approved by the Ethic Committee of the University of Medicine and Pharmacy "Gr. T Popa" Iasi to be conducted at the Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi. The patients are assigned after a randomized scheme to one of the groups: diet restriction scheme or diet restriction scheme plus a product with inuline, choline and silymarin. After 28 days the patients are crossed between the groups and followed for additional 28 days diet scheme with or without inuline, choline and silymarin supplementation. All the patients are evaluated initially, in the day 28 and in the day 57 for the stool habits, stool characteristics using Brystol Scale and symptoms severity (abdominal pain, frequency of abdominal pain, bloating severity, patients satisfaction in relation with stool frequency and the impact of IBS on daily activity) as appreciated by the patients for the last 10 days.\n\nThe acquired data will be analyzed and published.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 18-75 years, diagnosed with Irritable Bowel Syndrome using Roma IV criteria\n\nExclusion Criteria:\n\n* Patients with IBS with predominant diarrhea or mixt symptoms\n* Patients with known hypersensitivity to any of the ingredients of the dietary supplement\n* Patients who used prebiotic, probiotic or laxative products in the last 10 days\n* Pregnancy and lactation'}, 'identificationModule': {'nctId': 'NCT03174561', 'briefTitle': 'Inuline Supplement in Patients With Irritable Bowel Syndrome', 'organization': {'class': 'INDUSTRY', 'fullName': 'SC Fiterman Pharma SRL'}, 'officialTitle': 'Clinical Assessment of the Benefits of the Combination Inuline, Choline and Silymarin in Mitigating the Symptomatology in Patients With Irritable Bowel Syndrome', 'orgStudyIdInfo': {'id': 'STCL009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Inuline, Choline and Silymarin + Diet', 'description': 'Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions together with a dietary supplement.\n\nIntervention: Dietary Supplement, a combination of Inuline, Silymarin and Choline The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days', 'interventionNames': ['Dietary Supplement: Inuline, Choline and Silymarin']}, {'type': 'OTHER', 'label': 'Diet restriction', 'description': 'Patients diagnosed with Irritable bowel syndrome who will follow diet restrictions for 28 days. After the first month the patients are crossed between groups.', 'interventionNames': ['Other: diet restriction']}], 'interventions': [{'name': 'Inuline, Choline and Silymarin', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Stoptoxin plicuri'], 'description': 'Combination of one sachet: Inuline (5000 mg), Silybum marianum seed extract (50 mg), Choline (37 mg) The dose: 1 sachet first 7 days and 1 sachet x 2 times daily for the next 21 days. Diet restriction is consider together with dietary supplement intake.', 'armGroupLabels': ['Inuline, Choline and Silymarin + Diet']}, {'name': 'diet restriction', 'type': 'OTHER', 'description': 'diet restriction for 28 days', 'armGroupLabels': ['Diet restriction']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Iași', 'status': 'RECRUITING', 'country': 'Romania', 'contacts': [{'name': 'Vasile L Drug, Lecturer', 'role': 'CONTACT', 'email': 'vasidrug@email.com'}], 'facility': 'Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon"', 'geoPoint': {'lat': 47.16667, 'lon': 27.6}}], 'centralContacts': [{'name': 'Vasile L Drug, Lecturer', 'role': 'CONTACT', 'email': 'vasidrug@email.com', 'phone': '+40745589065'}], 'overallOfficials': [{'name': 'Vasile L Drug, Lecturer', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Gastroenterology and Hepatology of Clinical Emergency Hospital "Sf. Spiridon" Iasi'}, {'name': 'Ioan Chirila, Consultant', 'role': 'STUDY_CHAIR', 'affiliation': 'National Institute of public Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SC Fiterman Pharma SRL', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}