Clinical trial NCT01787253: Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)
Official title: Microbe-Gut Interaction in Microscopic Colitis and Post-Infectious Irritable Bowel Syndrome (IBS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Irritable Bowel Syndrome (IBS)
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2013-02-08
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from clinic (endoskopimotagningen) at Örebro University Hospital.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Lymphocyte characterization
timeFrame: After one year of initial infection before treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
state: Närke
Study officials:
affiliation: Örebro Universitet
name: Robert Brummer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: