Synbiotic Dietary Supplement and Gut Microbiota

Completed

Conditions studied: Healthy

In brief

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

Key facts

Study ID

NCT04097106

Run by

The Cleveland Clinic

People needed

34

Starts

2020-11-10

Expected to finish

2022-06-27

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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