The QIB Colon Model

NCT02653001 | Enrolling By Invitation

• 1 other identifier: IFR01/2015
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to establish a list of volunteers willing and able to donate stool samples for use in the model colon so as to facilitate research directed toward understanding the basic science underlying the interactions between the gut microbiome, potential external modifiers, and health.

Conditions

Human Gut Microbiota

Keywords

in vitro gut model, colon model, stool sample, faecal sample, gut microbiome

Outcome Measures

Primary Outcomes (1)

• Measurement of 16S rDNA gene (%)

  Measurement of 16S rDNA gene in human stool samples will reflect the bacterial population of the colon.

  Across an initial period of ten years

Secondary Outcomes (4)

• Methane concentration (mmol/L)

  Across an initial period of ten years

• Concentration of short chain fatty acids (mM)

  Across an initial period of ten years

• Glucosinolate concentration (mM)

  Across an initial period of ten years

• Fiber concentration (mM)

  Across an initial period of ten years

Study Arms (1)

Experimental arm

EXPERIMENTAL

Stool sample collection: Stool samples collected from study participants will be introduced into the colon model to enhance our understanding of the colonic bacterial ecosystem in response to various food components, drugs or biological therapies, and/or to allow investigation the impact of the bacterial ecosystem itself on these added components

Other: Stool sample collection

Interventions

Stool sample collection OTHER

Collection of complete stool sample

Experimental arm

Eligibility Criteria

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

You may qualify if:

• Live or work within 10 miles of the Norwich Research Park.
• Having a normal bowel habit; assessed as regular defecation between 3 times a day and 3 times a week, with a form similar to 3-5 on the Bristol Stool Chart.
• Do not have any diagnosed chronic gastrointestinal health problem, such as irritable bowel syndrome, inflammatory bowel disease, or coeliac disease.

You may not qualify if:

• This will depend on individual experiments but in most cases samples will not be collected from individuals:
• who have used antibiotics or probiotics in the last 2 months.
• who are pregnant or breast feeding.
• who have recently used other medications or food supplements (considered on a study-specific basis).
• who have recently had an operation requiring general anaesthetic.
• who have had a gastrointestinal upset, such as vomiting or diarrhoea within the last 72hrs.

Sponsors & Collaborators

• Quadram Institute Bioscience: lead

Study Sites (1)

Quadram Institute Bioscience

Norwich, Norfolk, NR4 7UA, United Kingdom

Location

Related Publications (1)

• Day-Walsh P, Shehata E, Saha S, Savva GM, Nemeckova B, Speranza J, Kellingray L, Narbad A, Kroon PA. The use of an in-vitro batch fermentation (human colon) model for investigating mechanisms of TMA production from choline, L-carnitine and related precursors by the human gut microbiota. Eur J Nutr. 2021 Oct;60(7):3987-3999. doi: 10.1007/s00394-021-02572-6. Epub 2021 May 2.

  PMID: 33934200 DERIVED

Study Officials

• Emad Shehata, Ph.D

  Quadram Institute Bioscience

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: January 5, 2016
• First Posted: January 12, 2016
• Study Start: December 18, 2015
• Primary Completion (Estimated): May 1, 2030
• Study Completion (Estimated): May 1, 2030
• Last Updated: April 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)