Stability of the Microbiome in IBD and IBS

Microbiota Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395548
• Other study ID #: 29-255 ex 16/17
• Status: Completed
• Phase: N/A
• Start date: August 25, 2017
• Est. completion date: May 1, 2020

Study information

• Verified date: August 2020
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2020
• Est. primary completion date: May 1, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Microbiota

Intervention

Drug:
• Macrogol
Used drug: Macrogol (osmotic laxative)

Locations

Country	Name	City	State
Austria	Universitätsklinikum Graz	Graz	Styria

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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