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Completed

NCT Number: NCT01787253

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Örebro University Hospital

Örebro, Närke, 70185, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Lymphocyte characterization

    Time frame: After one year of initial infection before treatment

    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).

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Feb 8, 2013
Registry last updated
Feb 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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