Human Gut Microbiota and Prebiotic Response

Duke University

Status: Completed

Conditions: Healthy Gut Microbiota

Treatments: Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS); Dietary Supplement: Prebiotic A - inulin; Dietary Supplement: Prebiotic C - wheat dextrin

Study type: Interventional

Funder types: Other

Identifiers

NCT03595306

Pro00087214

Details and patient eligibility

About

This study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.

Enrollment: 41 patients

Sex: All

Ages: 17 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Provide Stool Samples at no risk to yourself

Exclusion criteria

• No oral antibiotic treatments within previous 1 month
• No known allergy to milk products or lactose intolerance
• no known allergy to wheat or gluten intolerance
• no history of irritable bowel syndrome
• no history of inflammatory bowel disease
• no history of type-2 diabetes
• no history of chronic kidney disease or reduced kidney function
• no current intestinal obstructions
• no current untreated colorectal cancer
• not currently pregnant or breastfeeding

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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41 participants in 3 patient groups

Prebiotic A

Experimental group

Treatment:

Dietary Supplement: Prebiotic A - inulin

Dietary Supplement: Prebiotic C - wheat dextrin

Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS)

Prebiotic B

Experimental group

Treatment:

Dietary Supplement: Prebiotic A - inulin

Dietary Supplement: Prebiotic C - wheat dextrin

Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS)

Prebiotic C

Experimental group

Treatment:

Dietary Supplement: Prebiotic A - inulin

Dietary Supplement: Prebiotic C - wheat dextrin

Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS)