Stability of the Microbiome in IBD and IBS

Study Overview
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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.

Detailed Description
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I

Official Title
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Stability of the Intestinal Microbiome in Patients Suffering From Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS) Under the Influence of an Osmotic Laxans

Conditions
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Microbiota

Intervention / Treatment
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* Drug: Macrogol


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Inflammatory bowel disease<br>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. | Drug: Macrogol<br>* Used drug: Macrogol (osmotic laxative)<br>|
| Active Comparator: Irritable bowel syndrome<br>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. | Drug: Macrogol<br>* Used drug: Macrogol (osmotic laxative)<br>|
| Active Comparator: Healthy<br>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. | Drug: Macrogol<br>* Used drug: Macrogol (osmotic laxative)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the microbiome | The investigators aim to asses the changes of the gut microbiome between the three Groups and before and after lavage (Alpha Diversity, Beta Diversity, Group Significance) | 4 months |