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

NCT01787253 | Completed

• 2 other identifiers: 2010-052010/261
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritable Bowel Syndrome (IBS)

Outcome Measures

Primary Outcomes (1)

• 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-CD8α-ECD (clone-SFCI21Thy2D3) and anti-CD8β-PECy5 (clone-2ST8.5 H7) were purchased from Beckman Coulter (Fullerton, CA, USA) whereas anti-CD38-PECy5 (clone-HIT2), anti-αβTCR-PECy5 (clone-IP26) and anti-γδTCR-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 (IgGκ-FITC, IgG2bκ-PE, IgG1-ECD, IgG2bκ-PECy5, IgG2κ-FITC, IgG1κ-PE, IgG1κ-PECy5, and IgG2a-PECy5).

  After one year of initial infection before treatment

Study Arms (4)

Irritable bowel syndrome (IBS)

Healthy controls

Microscopic Colitis (MC)

Irritable bowel disease (IBD)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from clinic (endoskopimotagningen) at Örebro University Hospital.

You may qualify if:

• Over 18 years
• Healthy and not eating any prescription medication except birth control in pill form

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead

Study Sites (1)

Örebro University Hospital

Örebro, Närke, 70185, Sweden

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsies and blood

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Robert Brummer, MD, PhD

  Örebro Universitet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean

Study Record Dates

• First Submitted: November 15, 2010
• First Posted: February 8, 2013
• Study Start: November 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: December 1, 2014
• Last Updated: February 24, 2021

Record last verified: 2021-02

Locations

SE (1)