Healthy
Conditions
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.
Interventions
DIETARY_SUPPLEMENTSynbiotic
Synbiotic dietary supplement in capsule form
Sponsors
The Cleveland Clinic
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in microbiome stool diversity | Baseline, Day 28, day 49, day 77 | — |
| Measure change in gastrointestinal symptoms using Rating of Gastrointestinal (GI) Symptoms scale | Baseline, Day 28, day 49, day 77 | Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score |
| Change in metabolome stool profile | Baseline, Day 28, day 49, day 77 | — |
| Change in metabolome urine profile | Baseline, Day 28, day 49, day 77 | — |
Countries
United States
Outcome results
None listed