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Synbiotic Dietary Supplement and Gut Microbiota

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04097106
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : January 23, 2020
Information provided by (Responsible Party):
Gail Cresci, The Cleveland Clinic

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

Condition or disease Intervention/treatment
Healthy Dietary Supplement: Synbiotic

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Study Type : Observational
Estimated Enrollment : 32 participants
Observational Model: Case-Crossover
Time Perspective: Prospective
Official Title: Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
Estimated Study Start Date : March 2020
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : October 2024

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. 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

  2. Change in microbiome stool diversity [ Time Frame: Baseline, Day 28, day 49, day 77 ]
  3. Change in metabolome stool profile [ Time Frame: Baseline, Day 28, day 49, day 77 ]
  4. Change in metabolome urine profile [ Time Frame: Baseline, Day 28, day 49, day 77 ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04097106

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Contact: Heather Wojanowski 216-445-2282

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United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Contact: Heather Wojanowski    216-445-2282   
Principal Investigator: Gail Cresci, PhD, RD         
Sponsors and Collaborators
The Cleveland Clinic
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Responsible Party: Gail Cresci, Director Nutrition Research within Center for Human Nutrition, The Cleveland Clinic Identifier: NCT04097106    
Other Study ID Numbers: IRB #19-601
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: January 23, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No