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Synbiotic Dietary Supplement and Gut Microbiota

Sponsor
The Cleveland Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT04097106
Collaborator
(none)
32
Enrollment
1
Location
46.7
Anticipated Duration (Months)
0.7
Patients Per Site Per Month

Study Details

Study Description

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 Phase
  • Dietary Supplement: Synbiotic

Study Design

Study Type:
Observational
Anticipated Enrollment :
32 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Synbiotic Supplement Effects on Gastrointestinal Symptoms and Gut Microbiota and Fecal Metabolomics
Actual Study Start Date :
Nov 10, 2020
Anticipated Primary Completion Date :
Oct 1, 2022
Anticipated Study Completion Date :
Oct 1, 2024

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

  2. Change in microbiome stool diversity [Baseline, Day 28, day 49, day 77]

  3. Change in metabolome stool profile [Baseline, Day 28, day 49, day 77]

  4. Change in metabolome urine profile [Baseline, Day 28, day 49, day 77]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Cleveland Clinic Foundation Cleveland Ohio United States 44195

Sponsors and Collaborators

  • The Cleveland Clinic

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gail Cresci, Director Nutrition Research within Center for Human Nutrition, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT04097106
Other Study ID Numbers:
  • IRB #19-601
First Posted:
Sep 20, 2019
Last Update Posted:
Dec 22, 2021
Last Verified:
Dec 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Dec 22, 2021