Stability of the Microbiome in IBD and IBS

Not Applicable

Completed

• Conditions: Microbiota
• Interventions: Drug: Macrogol

• Registration Number: NCT03395548
• Lead Sponsor: Medical University of Graz

Brief Summary

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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Study Timeline

• Study Start: 2017-08-25
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2018-01-03
• Study First Posted: 2018-01-10
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-10
• Last Update Posted: 2020-08-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Inflammatory bowel disease	Macrogol	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.
Irritable bowel syndrome	Macrogol	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.
Healthy	Macrogol	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.

Primary Outcome Measures

Name	Time	Method
Changes of the microbiome	4 months	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)

Trial Locations

Locations (1)

Universitätsklinikum Graz; 🇦🇹 Graz, Styria, Austria