Networks of Bacterium-Metabolite Interactions in the Small Intestine

NCT04978077 | Terminated

• 1 other identifier: 2021-01108
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Probands with an Ileo- or Colostomy are assigned to consume a test meal which is either high in fat or high in carbohydrates. After the test meal samples from the stoma, urine, blood and skin are retrieved. These will be subjected to large scale analyses of microbiota and metabolite content. To get a better comparability test subjects will consume a standardized liquid diet three days before the study day.

Conditions

Diet, Healthy; Microbial Colonization

Outcome Measures

Primary Outcomes (2)

• Identification of stimulating and inhibiting metabolite and bacteria interactions

  Correlation of results of secondary outcome measures to find interactions

  8 hours

• Reproduction of metabolite-bacteria interactions in vitro culture

  By culturing of bacteria with possible interactions together in vitro

  2 weeks

Secondary Outcomes (10)

• Analysis of bacteria species composition

  8 hours

• Cultivation of bacterial strains in various conditions including ileal fluids

  2 weeks

• Metabolite composition in intestinal fluids

  8 hours

• Metabolite composition in blood

  8 hours

• Metabolite composition in urine

  8 hours

Study Arms (2)

High fat test meal first, high carbohydrate test meal second

EXPERIMENTAL

Consumption of a high fat challenge first, consumption of a high carbohydrate challenge after two weeks wash out

Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

High carbohydrate test meal first, high fat test meal second

EXPERIMENTAL

Consumption of a high carbohydrate challenge first, consumption of a high fit challenge after two weeks wash out

Other: Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®)

Interventions

Test meal (high fat = Nutricia Calogen®, or high carbohydrate = Nutricia preOp®) OTHER

After a night fast participants will drink the test meal

High carbohydrate test meal first, high fat test meal second; High fat test meal first, high carbohydrate test meal second

Eligibility Criteria

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

You may qualify if:

• Written informed consent
• General good health
• Ileostomy or colostomy

You may not qualify if:

• Hematologic disorders with contraindication of blood draw
• 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

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: July 27, 2021
• Study Start: December 16, 2021
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 11, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: upon publication of study results open ended
• Access Criteria: public access

Locations

CH (1)