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Stability of the Microbiome in IBD and IBS

M

Medical University of Graz

Status

Completed

Conditions

Microbiota

Treatments

Drug: Macrogol

Study type

Interventional

Funder types

Other

Identifiers

NCT03395548
29-255 ex 16/17

Details and patient eligibility

About

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.

Full description

I

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 3 patient groups

Inflammatory bowel disease
Active Comparator group
Description:
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.
Treatment:
Drug: Macrogol
Irritable bowel syndrome
Active Comparator group
Description:
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.
Treatment:
Drug: Macrogol
Healthy
Active Comparator group
Description:
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.
Treatment:
Drug: Macrogol

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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