Stability of the Microbiome in IBD and IBS

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-25

Study Completion Date

2020-05-01

Brief Summary

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In this study the investigators aim to investigate the changes of the intestinal microbiome in three different cohorts (IBD, IBS, healthy) after applying the uniform disruptive factor of osmotic diarrhea induced by macrogol. The investigators hypothesis is that ill people will show more severe changes of the microbiome than healthy people and that these changes persist longer.

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Detailed Description

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I

Conditions

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Microbiota

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Inflammatory bowel disease

The aim is to recruit 20 persons suffering from Crohn's disease or ulcerative colitis with stable medication and stable control of the disease.

As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.

Group Type ACTIVE_COMPARATOR

Macrogol

Intervention Type DRUG

Used drug: Macrogol (osmotic laxative)

Irritable bowel syndrome

The aim is to recruit 20 persons suffering from irritable bowel syndrome (IBS) fulfilling rome criteria.

As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.

Group Type ACTIVE_COMPARATOR

Macrogol

Intervention Type DRUG

Used drug: Macrogol (osmotic laxative)

Healthy

The aim is to recruit 20 persons without known illnesses with a comparable age to the other two groups.

As in each group the intervention will be the colon lavage with macrogol in combination with the colonoscopy.

Group Type ACTIVE_COMPARATOR

Macrogol

Intervention Type DRUG

Used drug: Macrogol (osmotic laxative)

Interventions

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Macrogol

Used drug: Macrogol (osmotic laxative)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* patients with inflammatory bowel disease and irritable bowel syndrome and stable therapy since three months
* patients with the indication for colonoscopy

Exclusion Criteria

* age under 18
* pregnancy
* new therapy planned
* change of therapy within the last three months
* acute exacerbation of the inflammatory bowel disease
* colon pathologies of other origin: colocarcinoma, Illnesses with diarrhea (f.e.microscopic colitis), short bowel syndrome, malabsorption, colectomy
* intake of antibiotics in the last three months
* intake of probiotics in the last month
* intake of antibiotics or probiotics during the study
* new proton pump inhibitor therapy
* significant change of nutrition in the last three months
* holidays outside europe in the last month
* gastroenteritis in the last three months
* intake of laxatives
* nonsteroidal antiinflammatory drugs should be avoided and documented

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes