Stability of the Microbiome in IBD and IBS

Sponsor

Medical University of Graz (Other)

Overall Status

Completed

CT.gov ID

NCT03395548

Collaborator

(none)

Enrollment

Location

Arms

32.2

Actual Duration (Months)

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Microbiota	Drug: Macrogol	N/A

Detailed Description

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Aug 25, 2017

Actual Primary Completion Date :

May 1, 2020

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Macrogol Used drug: Macrogol (osmotic laxative)
Active Comparator: 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.	Drug: Macrogol Used drug: Macrogol (osmotic laxative)
Active Comparator: 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.	Drug: Macrogol Used drug: Macrogol (osmotic laxative)

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Macrogol

Used drug: Macrogol (osmotic laxative)

Active Comparator: 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.

Drug: Macrogol

Used drug: Macrogol (osmotic laxative)

Active Comparator: 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.

Drug: Macrogol

Used drug: Macrogol (osmotic laxative)

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universitätsklinikum Graz	Graz	Styria	Austria	8010

Sponsors and Collaborators

Medical University of Graz

Investigators

Principal Investigator: Andreas Blesl, MD, Medical University of Graz

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Medical University of Graz

ClinicalTrials.gov Identifier:

NCT03395548

Other Study ID Numbers:

29-255 ex 16/17

First Posted:

Jan 10, 2018

Last Update Posted:

Aug 11, 2020

Last Verified:

Aug 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 11, 2020