Low Carbohydrate Small Intestine Study

NCT04976686 | Terminated

• 1 other identifier: 2021-01262
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.

Conditions

Diet, Healthy

Outcome Measures

Primary Outcomes (1)

• Assessment of microbiota profile by 16S sequencing before and after diet modification for significant differences

  Sample content will be measured by 16S sequencing, ecological distances will be assessed by beta-diversity

  28 days

Secondary Outcomes (5)

• Relative changes of total metabolite abundance in urine

  28 days

• Analysis of microbiota metabolic potential (microbiome DNA coding for enzymes) after shotgun sequencing

  28 days

• Analysis of microbiota biomass

  28 days

• Changes of further metagenomic microbiome composition (viral, eucaryotic DNA)

  28 days

• Culturing of microbiota if appropriate (in vitro)

  28 days

Study Arms (1)

All study participants

EXPERIMENTAL

All participants will undergo sample collection during their regular diet and after modification of their diet to a low carbohydrate diet

Other: Diet modification

Interventions

Diet modification OTHER

Participants will reduce their carbohydrate consumption to 80g daily

All study participants

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Ileostomy or colostomy
• Good general health
• Written informed consent

You may not qualify if:

• Major metabolic diseases that prevent adherence to low carbohydrate diet
• Participation in other clinical trial interfering with study protocol

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Inselspital

Bern, 3010, Switzerland

Location

MeSH Terms

Interventions

Diet Therapy

Intervention Hierarchy (Ancestors)

Nutrition Therapy; Therapeutics

Study Officials

• Benjamin Misselwitz, Prof. Dr. med.

  University Clinic for Visceral Surgery and Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: First phase will be purely observational, second phase involves diet modification

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 26, 2021
• Study Start: November 17, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: upon publication, unlimited
• Access Criteria: Open access

Locations

CH (1)