Synbiotic Dietary Supplement and Gut Microbiota

December 4, 2024 updated by: Gail Cresci, The Cleveland Clinic

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

34

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44101
        • Kassandra Spates-Harden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Lean BMI (19-25)
Dietary supplement: Synbiotic
Synbiotic dietary supplement in capsule form
Obese BMI (30-35)
Dietary supplement: Synbiotic
Synbiotic dietary supplement in capsule form

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in gastrointestinal symptoms using "Rating of Gastrointestinal (GI) Symptoms" scale
Time Frame: 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
Baseline, Day 28, day 49, day 77
Change in microbiome stool diversity
Time Frame: Baseline, Day 28, day 49, day 77
Baseline, Day 28, day 49, day 77
Change in metabolome stool profile
Time Frame: Baseline, Day 28, day 49, day 77
Baseline, Day 28, day 49, day 77
Change in metabolome urine profile
Time Frame: Baseline, Day 28, day 49, day 77
Baseline, Day 28, day 49, day 77

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Cleveland Clinic

Investigators

  • Principal Investigator: Gail Cresci, The Cleveland Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2020

Primary Completion (Actual)

June 27, 2022

Study Completion (Actual)

June 27, 2022

Study Registration Dates

First Submitted

September 18, 2019

First Submitted That Met QC Criteria

September 18, 2019

First Posted (Actual)

September 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 9, 2024

Last Update Submitted That Met QC Criteria

December 4, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB #19-601

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on Synbiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe