Stability of the Microbiome in IBD and IBS

NCT03395548 | Completed

• 1 other identifier: 29-255 ex 16/17
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Microbiota

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Inflammatory bowel disease

ACTIVE COMPARATOR

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

Irritable bowel syndrome

ACTIVE COMPARATOR

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

Healthy

ACTIVE COMPARATOR

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

Interventions

Macrogol DRUG

Used drug: Macrogol (osmotic laxative)

Healthy; Inflammatory bowel disease; Irritable bowel syndrome

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Universitätsklinikum Graz

Graz, Styria, 8010, Austria

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Andreas Blesl, MD

  Medical University of Graz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2017
• First Posted: January 10, 2018
• Study Start: August 25, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Locations

AU (1)