Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT01268618
Status:
TERMINATED
Last Update Posted:
2011-07-21
First Post:
2010-12-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D004415', 'term': 'Dyspepsia'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}], 'ancestors': [{'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-07', 'completionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2011-07-20', 'studyFirstSubmitDate': '2010-12-28', 'studyFirstSubmitQcDate': '2010-12-30', 'lastUpdatePostDateStruct': {'date': '2011-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Abdominal pain severity', 'timeFrame': '8 weeks'}, {'measure': 'Stool consistency (Bristol Stool Chart)', 'timeFrame': '8 weeks'}, {'measure': 'Dyspepsia Symptom Severity Index (DSSI)', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'Proportion of subjects with 1 or more adverse events', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['IBS', 'Diarrhea', 'Dyspepsia'], 'conditions': ['IBS-D and Functional Dyspepsia']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n• To confirm the efficacy of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in the improvement of symptoms in adult patients with diarrhea-predominant irritable bowel syndrome (IBS-D) and functional dyspepsia\n\nSecondary Objective:\n\n• To confirm the safety of the probiotic product Healthy Trinity (retail label)/Trenev Trio (professional label) in adult patients with IBS-D and functional dyspepsia'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age 18 to 75 years\n2. Diagnosed with IBS-D including: a) weekly average of worst abdominal pain in the last 24 hours of ≥3 on a 0-10 scale, and b) weekly average of Bristol Stool form of ≥6 on a 1-7 scale\n3. Diagnosed with functional dyspepsia defined as presence of at least one of the following symptoms: bothersome postprandial fullness, early satiation, epigastric pain, or epigastric burning AND no evidence of structural disease that is likely to explain the symptoms\n4. History of IBS-D and dyspepsia symptoms for at least 12 weeks\n5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)\n6. Able to understand the nature and purpose of the study including potential risks and side effects\n7. Willing to consent to study participation and to comply with study requirements\n8. Successful completion of 2-week placebo-only run-in period, defined as ≥90% product compliance and completion of required questionnaires\n\nExclusion Criteria:\n\n1. Major gastrointestinal complication, e.g. Crohn's disease or ulcer\n2. Prior abdominal surgery with the exception of hernia repair and appendectomy\n3. Subjects over 60 years who have not had a sigmoidoscopy or colonoscopy in the past 10 years\n4. Clinically significant systemic disease\n5. Life expectancy \\< 6 months\n6. Pregnant female or breastfeeding\n7. Lactose intolerance\n8. Immunodeficient subjects\n9. Anti-psychotic medication within the prior 3 months or major psychiatric disorder within the past 2 years\n10. Systemic steroids within the prior month\n11. Current treatment with nasogastric tube, ostomy, or parenteral nutrition\n12. Use of proton pump inhibitors\n13. Eating disorder\n14. Recent (\\< 2 weeks) antibiotic administration\n15. History of alcohol, drug, or medication abuse\n16. Daily consumption of probiotics, fermented milk, and/or yogurt\n17. Known allergies to any substance in the study product\n18. Participation in another study with any investigational product within 3 months of screening"}, 'identificationModule': {'nctId': 'NCT01268618', 'briefTitle': 'Trenev Trio/Healthy Trinity for Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS) and Functional Dyspepsia', 'organization': {'class': 'OTHER', 'fullName': 'Sprim Advanced Life Sciences'}, 'officialTitle': 'A Double-blind, Randomized, Placebo-controlled, Dual-center Study on the Effect of Healthy Trinity (Retail Label)/Trenev Trio (Professional Label) on Symptoms of Diarrhea-predominant Irritable Bowel Syndrome (IBS-D) and Functional Dyspepsia', 'orgStudyIdInfo': {'id': '10-SUS-05-NAT-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Probiotic', 'interventionNames': ['Dietary Supplement: Probiotic']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Probiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules, 3x/day capsules of Healthy Trinity (retail label)/Trenev Trio (professional label), for a total daily dose of:\n\n1. Lactobacillus acidophilus NAS, 30 billion CFU\n2. Bifidobacterium bifidum Malyoth, 120 billion CFU\n3. Lactobacillus delbrueckii subspecies bulgaricus LB-51, 30 billion CFU', 'armGroupLabels': ['Probiotic']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': '2 capsules, 3x/day placebo capsules', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30096', 'city': 'Duluth', 'state': 'Georgia', 'country': 'United States', 'facility': 'In-Quest Medical Research, LLC', 'geoPoint': {'lat': 34.00288, 'lon': -84.14464}}, {'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Clinical Research Associates of Tidewater', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Duane Wombolt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinical Research Associates of Tidewater'}, {'name': 'David Wyatt, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'In-Quest Medical Research, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sprim Advanced Life Sciences', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Larry Miller, PhD', 'oldOrganization': 'Sprim Advanced Life Sciences'}}}}