Stability of the Microbiome in IBD and IBS

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03395548

Enrollment

Registered

2018-01-10

Start date

2017-08-25

Completion date

2020-05-01

Last updated

2020-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Microbiota

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

Interventions

DRUGMacrogol

Used drug: Macrogol (osmotic laxative)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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)

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026