The QIB Colon Model

Human Gut Microbiota Clinical Trial

Official title:

Stool Sample Collection for Research Using the In-vitro QIB Colon Model

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02653001
• Other study ID #: IFR01/2015
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 18, 2015
• Est. completion date: December 2025

Study information

• Verified date: May 2022
• Source: Quadram Institute Bioscience
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Human Gut Microbiota

Intervention

Other:
• Stool sample collection
Collection of complete stool sample

Locations

Country	Name	City	State
United Kingdom	Quadram Institute Bioscience	Norwich	Norfolk

Sponsors (1)

Lead Sponsor	Collaborator
Quadram Institute Bioscience

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Methane concentration (mmol/L)	Measurement of methane concentration in gaseous production of human stool samples in colon model.	Across an initial period of ten years
Secondary	Concentration of short chain fatty acids (mM)	Concentration of short chain fatty acids in the colon model milieu.	Across an initial period of ten years
Secondary	Glucosinolate concentration (mM)	Concentration of glucosinolates in the colon model milieu.	Across an initial period of ten years
Secondary	Fiber concentration (mM)	Concentration of fiber in the colon model milieu.	Across an initial period of ten years