Synbiotic Dietary Supplement and Gut Microbiota

Study Overview
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Brief Summary
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To test the feasibility and safety of our designer synbiotic on gastrointestinal symptoms and gut microbiota and fecal metabolomics.

Detailed Description
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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.

Official Title
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Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: Synbiotic


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lean BMI (19-25)<br> | Dietary Supplement: Synbiotic<br>* Synbiotic dietary supplement in capsule form<br>|
| Obese BMI (30-35)<br> | Dietary Supplement: Synbiotic<br>* Synbiotic dietary supplement in capsule form<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure change in gastrointestinal symptoms using Rating of Gastrointestinal (GI) Symptoms scale | Rating of GI Symptoms scale includes 5 questions, which range from 0 (never affected) to 7 (always bothered), summed to compute total score | Baseline, Day 28, day 49, day 77 | 
| Change in microbiome stool diversity |  | Baseline, Day 28, day 49, day 77 | 
| Change in metabolome stool profile |  | Baseline, Day 28, day 49, day 77 | 
| Change in metabolome urine profile |  | Baseline, Day 28, day 49, day 77 |