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CompletedNCT03395548Updated Aug 11, 2020

Stability of the Microbiome in IBD and IBS

An interventional study of Macrogol in Microbiota, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-11.

Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

I

02

Conditions studied

  • Microbiota
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
04

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
50 participants (actual)

Study arms

  • 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

  • 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

  • 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

Interventions

  • DrugMacrogol

    Used drug: Macrogol (osmotic laxative)

05

What researchers measure

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)

    Time frame: 4 months

06

Study locations

1 site
  • Universitätsklinikum Graz
    Graz, Styria 8010, Austria
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03395548
Lead sponsor
Medical University of Graz
Responsible party
Sponsor
First posted
Jan 10, 2018
Start date
Aug 25, 2017
Primary completion
May 1, 2020
Completion
May 1, 2020
Last update
Aug 11, 2020

Study contacts

Andreas Blesl, MD
principal investigator · Medical University of Graz

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

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