Ignite Creation Date:
2025-12-24 @ 2:53 PM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT01444859
Status:
UNKNOWN
Last Update Posted:
2012-10-24
First Post:
2011-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D015444', 'term': 'Exercise'}], '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'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, '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': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'completionDateStruct': {'date': '2012-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-10-23', 'studyFirstSubmitDate': '2011-09-28', 'studyFirstSubmitQcDate': '2011-09-29', 'lastUpdatePostDateStruct': {'date': '2012-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean total Gastrointestinal Symptom Rating Scale (GSRS) score', 'timeFrame': '10 weeks'}, {'measure': 'Gastrointestinal Quality of Life Index (GIQLI) total score', 'timeFrame': '10 weeks'}], 'secondaryOutcomes': [{'measure': 'Gastrointestinal Symptom Rating Scale subscores', 'timeFrame': '10 weeks'}, {'measure': 'Gas severity', 'timeFrame': '10 weeks'}, {'measure': 'Bloating severity', 'timeFrame': '10 weeks'}, {'measure': 'Acid indigestion severity', 'timeFrame': '10 weeks'}, {'measure': 'Abdominal cramping severity', 'timeFrame': '10 weeks'}, {'measure': 'Stool consistency (measured with Bristol Stool Form Scale)', 'timeFrame': '10 weeks'}, {'measure': 'Stool frequency', 'timeFrame': '10 weeks'}, {'measure': 'Concomitant medication use', 'timeFrame': '10 weeks'}, {'measure': 'Adverse event frequency', 'timeFrame': '10 weeks'}, {'measure': 'Adverse event severity', 'timeFrame': '10 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Recurrent Gastrointestinal Symptoms']}, 'descriptionModule': {'briefSummary': 'Clinical trial to compare safety and effectiveness of 10-week supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms.', 'detailedDescription': 'This study is a double-blind, randomized, placebo-controlled, parallel group trial comparing the safety and effectiveness of supplementation with Trenev Trio®/Healthy Trinity® vs. placebo in otherwise healthy subjects with recurrent gastrointestinal symptoms. Subjects will be recruited and, following successful completion of a 2-week run-in period, will be randomized to Trenev Trio®/Healthy Trinity® or placebo and will consume their assigned study product daily for 10 weeks. The study endpoints of this trial include relief of overall gastrointestinal symptoms, acid indigestion, abdominal cramping, constipation, diarrhea, gas, and bloating as well as product safety over the 10-week supplementation period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥18 years\n2. Body mass index between 18.5 through 39.9 kg/m2\n3. At least three symptoms rated between 4 to 6 in severity (moderate to severe discomfort) on a 1 to 7 scale, one of which must be acid indigestion as determined by the "Reflux Syndrome" score\n4. Self-reported "acid indigestion" symptoms (including pain/discomfort beneath the breastbone, bitter fluid in the mouth, or bloating/nausea after eating) at least 3 times per week over the previous 4 weeks\n5. Agree to use contraception throughout study period, unless postmenopausal or surgically sterile (females only)\n6. Able to understand and voluntarily consent to the study and understand it\'s nature and purpose including potential risks, and side effects\n\nExclusion Criteria:\n\n1. Any GSRS symptom rated a 7 in severity (very severe discomfort) on a 1 to 7 scale\n2. Diagnosed gastrointestinal disease/complication or functional bowel disorder (e.g. IBS, functional constipation, IBD, ulcer, etc.) based on physical examination or documented medical history that, in the investigator\'s opinion, may affect subject safety or confound the evaluation of the study endpoints\n3. Any non-gastrointestinal disease/complication that, in the investigator\'s opinion, may affect subject safety or confound the evaluation of the study endpoints\n4. Regular (\\>3 days per week) prescription medication use for any gastrointestinal disease/condition\n5. Recent (\\<6 months) abdominal surgery for any reason\n6. Immunodeficiency\n7. Recent change in anti-psychotic medication within the previous 3 months\n8. Systemic steroid use within the prior month, excluding regular use of asthma medication\n9. Pregnant female or breastfeeding\n10. Eating disorder\n11. Recent (within 2 weeks) antibiotic administration\n12. History of alcohol, drug, or medication abuse\n13. Daily consumption of probiotics, fermented milk, and/or yogurt\n14. Known allergies to any substance in the study product\n15. Participation in another study with any investigational product within 30 days of screening'}, 'identificationModule': {'nctId': 'NCT01444859', 'briefTitle': 'Trenev Trio®/Healthy Trinity® for Recurrent Gastrointestinal Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Sprim Advanced Life Sciences'}, 'officialTitle': 'Effect of Trenev Trio®/Healthy Trinity® in Otherwise Healthy Adults With Recurrent Gastrointestinal Symptoms: a Double-blind, Randomized, Placebo-controlled, Parallel Group Study', 'orgStudyIdInfo': {'id': '110725-SUS-NIP-GIS-RA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo capsule', 'description': '40 subjects allocated to daily placebo capsule for 10 weeks', 'interventionNames': ['Dietary Supplement: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Trenev Trio®/Healthy Trinity®', 'description': '80 subjects allocated to Trenev Trio®/Healthy Trinity® for 10 weeks', 'interventionNames': ['Dietary Supplement: Trenev Trio®/Healthy Trinity®']}], 'interventions': [{'name': 'Trenev Trio®/Healthy Trinity®', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Probiotic', 'Active'], 'description': 'Trenev Trio®/Healthy Trinity® (1 capsule, 2x/day for 10 weeks), which offers a daily dose of: a) Lactobacillus acidophilus NAS strain (10 billion CFU), b) Bifidobacterium bifidum Malyoth strain (40 billion CFU), and c) Lactobacillus delbrueckii subspecies bulgaricus LB-51 strain (10 billion CFU)', 'armGroupLabels': ['Trenev Trio®/Healthy Trinity®']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Inactive', 'Control'], 'description': 'Daily placebo for 10 weeks', 'armGroupLabels': ['Placebo capsule']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90036', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Axis Clinical Trials', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94109', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Sprim ALS', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '19609', 'city': 'West Lawn', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 40.32981, 'lon': -75.99438}}, {'zip': '75010', 'city': 'Carrollton', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Across America', 'geoPoint': {'lat': 32.95373, 'lon': -96.89028}}, {'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': 'Jeffrey Stewart, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Across America'}, {'name': 'Michael Sinitsa, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Research Across America'}, {'name': 'Helen Stacey, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Diablo Clinical Research'}, {'name': 'Lydie Hazan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Axis Clinical Trials'}, {'name': 'JoAnn Hattner, MPH, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sprim ALS'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sprim Advanced Life Sciences', 'class': 'OTHER'}, 'collaborators': [{'name': 'The National Institute of Probiotics', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}