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Effects of controlled diet and prebiotics on the microbiome

Predictability and persistence of prebiotic dietary supplementation in a healthy human cohort

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN53935058
Enrollment
75
Registered
2018-02-23
Start date
2015-07-01
Completion date
Unknown
Last updated
2019-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diet and the microbiome Nutritional, Metabolic, Endocrine Diet and the microbiome

Interventions

This study aims to identify the microbial responders to specific micronutrients in the human diet. By placing a cohort of approximately 50 healthy human individuals on a diet consisting entirely of a
microbiome composition is measured throughout the course of the intervention. The study involves comparing the effects of a controlled diet in contrast to a variable diet on the compo

Sponsors

MIT Center for Microbiome Informatics and Therapeutics
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Individuals between 18-70 years of age 2. BMI between 18-25 or above 30 3. A waist-to-hip ratio of more than 0.9

Exclusion criteria

Exclusion criteria: 1. Food allergies 2. Inability to comply with study procedure 3. Suffer from IBS, IBD, Type-2 diabetes, kidney disease or intestinal obstruction 4. Allergic to polyethylene glycol 5. Have received antibiotics in the last 6 months 6. Have untreated, in situ colorectal cancer 7. Are currently pregnant, planning to get pregnant in the next 60 days, or currently breastfeeding

Design outcomes

Primary

MeasureTime frame
Gut microbiota composition is measured using the stool samples collected on the two first baseline days and on each day during the provided dietary regimen. This consists of a maximum of 10 stool samples (two baseline, six intervention, and two follow-up), which are sequenced for the 16S rRNA gene.

Secondary

MeasureTime frame
The effect of the diet on the microbiota at the level of genes and bacterial strains are processed for metagenomics sequencing at the second baseline sample, day 3 sample, and day 6 sample.

Countries

United States of America

Contacts

Public ContactEric Alm

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026