The QIB Colon Model

Sponsor
Quadram Institute Bioscience (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT02653001
Collaborator
(none)
20
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Stool sample collection
N/A

Detailed Description

Adult volunteers will be recruited to donate stool samples for laboratory-based experiments. Once the sample has arrived at QIB 50-100g will be added to the colon model and, depending on the system used, either cultured for 24h or for up to 40 days. During this time, factors under investigation will be added to the model.

Samples added mimic food chyme arriving at the ileal-caecal valve in the intestinal tract. At this stage digested, but non-absorbed food components plus cells and mucous shed from the lining of the small intestine enter the large intestine. Samples of bacteria and media can be taken at any point during the incubation.

Two models are used

  1. a simple batch culture in which bacteria, media and test compounds are added to a single compartment and analysed over 24h

  2. a three compartment model with continuous flow of media, test compounds and bacteria from the entrance port of the first chamber to the exit of the third chamber mimicking movement through the three main compartments of the colon. This model allows for a stable bacterial population to be established before addition of test compounds, and can remain viable for up to 40 days. In the case of these longer incubations, multiple time points can allow for quite complex experiments looking at interactions between bacteria, food and pharmaceutical products where different factors are added at different time points.

Samples collected during the incubation will be analysed by centrifuging the sample to create a pellet containing bacteria and a supernatant containing a wide range of metabolites. The bacteria will be analysed by extracting their DNA for genomic analysis or using RNA based approaches. On occasion, conventional microbiological techniques might be used. The supernatant will be filter sterilised prior to analysis of its chemical composition by techniques such as mass spectrometry, gel electrophoresis, or chromatography. Alternatively the supernatant may be added to cell lines to model the interaction between the bacterial ecosystem and the cells lining the colon.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Stool Sample Collection for Research Using the In-vitro QIB Colon Model
Actual Study Start Date :
Dec 18, 2015
Anticipated Primary Completion Date :
Dec 1, 2025
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental arm

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
Collection of complete stool sample

Outcome Measures

Primary Outcome Measures

  1. Measurement of 16S rDNA gene (%) [Across an initial period of ten years]

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

Secondary Outcome Measures

  1. Methane concentration (mmol/L) [Across an initial period of ten years]

    Measurement of methane concentration in gaseous production of human stool samples in colon model.

  2. Concentration of short chain fatty acids (mM) [Across an initial period of ten years]

    Concentration of short chain fatty acids in the colon model milieu.

  3. Glucosinolate concentration (mM) [Across an initial period of ten years]

    Concentration of glucosinolates in the colon model milieu.

  4. Fiber concentration (mM) [Across an initial period of ten years]

    Concentration of fiber in the colon model milieu.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • 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.

Exclusion Criteria:

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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Quadram Institute Bioscience Norwich Norfolk United Kingdom NR4 7UA

Sponsors and Collaborators

  • Quadram Institute Bioscience

Investigators

  • Principal Investigator: Arjan Narbad, Ph.D, Quadram Institute Bioscience

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Quadram Institute Bioscience
ClinicalTrials.gov Identifier:
NCT02653001
Other Study ID Numbers:
  • IFR01/2015
First Posted:
Jan 12, 2016
Last Update Posted:
May 5, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No

Study Results

No Results Posted as of May 5, 2022