Synbiotic Dietary Supplement and Gut Microbiota

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: Synbiotic

• Registration Number: NCT04097106
• Lead Sponsor: The Cleveland Clinic

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.

Study Timeline

• Study First Submitted: 2019-09-18
• Study First Submitted QC: 2019-09-18
• Study First Posted: 2019-09-20
• Study Start: 2020-11-10
• Primary Completion: 2022-06-27
• Study Completion: 2022-06-27
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Lean BMI (19-25)	Synbiotic	-
Obese BMI (30-35)	Synbiotic	-

Primary Outcome Measures

Name	Time	Method
Change in microbiome stool diversity	Baseline, Day 28, day 49, day 77
Change in metabolome urine profile	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

Trial Locations

Locations (1)

Kassandra Spates-Harden; 🇺🇸 Cleveland, Ohio, United States