Status:
COMPLETED
Synbiotic Dietary Supplement and Gut Microbiota
Lead Sponsor:
The Cleveland Clinic
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Brief Summary
To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.
Detailed Description
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.
Eligibility Criteria
Inclusion
- BMI 19-25 (lean) and BMI 30-35 (obese)
- Age 18-45 years old
- subjects must be willing to consume oral dietary supplement and placebo daily for a total of 56 days,
- 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)
Exclusion
- antibiotic consumption within 28 days of study initiation
- diabetes
- kidney disorders
- history of cardiac disease and medications for cardiac disease
- use of statins and antihypertensive drugs
- inflammatory bowel disease
- irritable bowel syndrome
- history of small intestinal bacterial overgrowth
- history of intestinal surgery, excluding hernia repair and appendectomy
- active cancer diagnosis; chronic acid suppression treatment (proton pump inhibitors, histamine H2 receptor antagonists)
- immune modulatory treatments (e.g. chronic immunosuppressive medications, chronic NSAIDs)
- abnormal liver or kidney function as measured by routine serum chemistry testing
- severe anemia or significant white blood cell or platelet abnormalities
- no additional blood or blood product donations during study
Key Trial Info
Start Date :
November 10 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04097106
Start Date
November 10 2020
End Date
June 27 2022
Last Update
December 9 2024
Active Locations (1)
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1
Kassandra Spates-Harden
Cleveland, Ohio, United States, 44101