Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)

Irritable Bowel Syndrome (IBS) Clinical Trial

Official title:

Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01787253
• Other study ID #: 2010-05
• Secondary ID: 2010/261
• Status: Completed
• Start date: November 2010
• Est. completion date: December 2014

Study information

• Verified date: February 2021
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Objective: This study aims elucidate the pathophysiological link between the environment in the colon (mainly the microbiota), the local immune system and activation of the enteric nervous system in patients with post-infectious IBS (PI-IBS) and microscopic colitis (MC) with special emphasis on microbial-mucosa interactions and evaluation of the effect on the immune activation/response as well as how afferent gut-brain signalling leads to abdominal discomfort.

Method: The project is based on data from three cohorts of patients, one with PI-IBS and one with MC as well as a gender- and age-matched cohort of healthy individuals. Measurement of perceived sensitivity in the gut will be evaluated by pain-response under mechanical stress using a barostat. The HIT (Human intestinal Tissue)-Chip array will be used to characterize the diversity, stability and functionality of the intestinal microbiota on mucosa level, giving a clue to the interactions with the host and insight to changes leading to the development of the two diseases.

Immunohistochemistry and flowcytometry will be used to analyse the location, frequency and phenotype characteristics of lymphoid- and mast cells. Functional analysis of mucosal lymphocytes activated in vitro by products from the intestinal microbiota will be examined by cytokine production using the LuminexTM system. The Ussing chamber technique will allow investigation of the impact of the microbiota and its metabolites on intestinal barrier functions. In this method the sample has access to stressors under standard conditions.

Description:

We will make a characterization of lymphocytes, mast cells and gut microflora. Depending on these results we will make stimulations of patient biopsies to find if tissue from patients react differently then patients from healthy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Over 18 years

• Healthy and not eating any prescription medication except birth control in pill form

Exclusion Criteria:

• Have or had a history of gastrointestinal disease that has required specialist medical care

• Being lactose intolerance

• Have high blood pressure requiring treatment

• Have premenstrual syndrome

• Lose Weight

• Being pregnant or breast-feed

Related Conditions & MeSH terms

• Colitis
• Colitis, Microscopic
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome (IBS)
• Syndrome

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro	Närke

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lymphocyte characterization	LPLs and IELs stained with the following flourochrome-conjugated antibodies: anti-CD3-FITC (clone-HIT3a), anti-CD4-FITC/PECy5 (clone-RPA-T4), anti-CD45RA-PE (clone-HI 100), anti-CD45RO-PECy5 (clone-UCHL1), anti-CD19-PE (clone-HIB19) and anti-CD138-FITC (clone-MI15), all from BD Pharmingen (San Diego, CA, USA). Anti-CD8a-ECD (clone-SFCI21Thy2D3) and anti-CD8ß-PECy5 (clone-2ST8.5 H7) were purchased from Beckman Coulter (Fullerton, CA, USA) whereas anti-CD38-PECy5 (clone-HIT2), anti-aßTCR-PECy5 (clone-IP26) and anti-?dTCR-PE (clone-B1) were purchased from Biolegend (San Diego, CA, USA). Fluorochrome-conjugated isotype matched control antibodies were used as controls for non-specific staining, and were purchased from BD Pharmingen or Beckman Coulter (IgG?-FITC, IgG2b?-PE, IgG1-ECD, IgG2b?-PECy5, IgG2?-FITC, IgG1?-PE, IgG1?-PECy5, and IgG2a-PECy5).	After one year of initial infection before treatment