Ignite Creation Date:
2025-12-26 @ 4:03 PM
Ignite Modification Date:
2026-03-02 @ 4:05 AM
Study NCT ID:
NCT04097106
Status:
COMPLETED
Last Update Posted:
2024-12-09
First Post:
2019-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Synbiotic Dietary Supplement and Gut Microbiota
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D058616', 'term': 'Synbiotics'}], 'ancestors': [{'id': 'D056692', 'term': 'Prebiotics'}, {'id': 'D019587', 'term': 'Dietary Supplements'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019936', 'term': 'Probiotics'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-04', 'studyFirstSubmitDate': '2019-09-18', 'studyFirstSubmitQcDate': '2019-09-18', 'lastUpdatePostDateStruct': {'date': '2024-12-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale', 'timeFrame': 'Baseline, Day 28, day 49, day 77', 'description': 'Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score'}, {'measure': 'Change in microbiome stool diversity', 'timeFrame': 'Baseline, Day 28, day 49, day 77'}, {'measure': 'Change in metabolome stool profile', 'timeFrame': 'Baseline, Day 28, day 49, day 77'}, {'measure': 'Change in metabolome urine profile', 'timeFrame': 'Baseline, Day 28, day 49, day 77'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.', 'detailedDescription': 'This will be a double-blinded, randomized, placebo-controlled paired crossover pilot study in healthy controls aimed to evaluate gastrointestinal tolerance of a synbiotic dietary supplement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Thirty two healthy volunteers, aged 18-45 years old, will be recruited for this pilot study, plan to enroll 16 subjects with a BMI 19-25 kg/m2 and 16 subjects with a BMI 30-35 kg/m2.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI 19-25 (lean) and BMI 30-35 (obese)\n* Age 18-45 years old\n* subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,\n* willing to complete gastrointestinal (GI) and dietary surveys, body composition assessment, and provide blood, urine and stool sample at 4 intervals during the pilot study (baseline, after first supplementation period (day 28), after washout period (day 49), and after second supplementation period (day 77)\n\nExclusion Criteria:\n\n* antibiotic consumption within 28 days of study initiation\n* diabetes\n* kidney disorders\n* history of cardiac disease and medications for cardiac disease\n* use of statins and antihypertensive drugs\n* inflammatory bowel disease\n* irritable bowel syndrome\n* history of small intestinal bacterial overgrowth\n* history of intestinal surgery, excluding hernia repair and appendectomy\n* active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)\n* immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)\n* abnormal liver or kidney function as measured by routine serum chemistry testing\n* severe anemia or significant white blood cell or platelet abnormalities\n* no additional blood or blood product donations during study'}, 'identificationModule': {'nctId': 'NCT04097106', 'briefTitle': 'Synbiotic Dietary Supplement and Gut Microbiota', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics', 'orgStudyIdInfo': {'id': 'IRB #19-601'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lean BMI (19-25)', 'interventionNames': ['Dietary Supplement: Synbiotic']}, {'label': 'Obese BMI (30-35)', 'interventionNames': ['Dietary Supplement: Synbiotic']}], 'interventions': [{'name': 'Synbiotic', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Synbiotic dietary supplement in capsule form', 'armGroupLabels': ['Lean BMI (19-25)', 'Obese BMI (30-35)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44101', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Kassandra Spates-Harden', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Gail Cresci', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Nutrition Research within Center for Human Nutrition', 'investigatorFullName': 'Gail Cresci', 'investigatorAffiliation': 'The Cleveland Clinic'}}}}