Synbiotic Dietary Supplement and Gut Microbiota

NeuroTherapia, Inc.

Status: Completed

Conditions: Healthy

Treatments: Dietary Supplement: Synbiotic

Study type: Observational

Funder types: Other

Identifiers

NCT04097106

IRB #19-601

Details and patient eligibility

About

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

Full 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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

34 participants in 2 patient groups

Lean BMI (19-25)

Treatment:

Dietary Supplement: Synbiotic

Obese BMI (30-35)

Treatment:

Dietary Supplement: Synbiotic