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Completed

NCT Number: NCT03395548

Stability of the Microbiome in IBD and IBS

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.

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Key information

Conditions

Microbiota

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinikum Graz

Graz, Styria, 8010, Austria

About this study

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Macrogol

Drug

Used drug: Macrogol (osmotic laxative)

Primary outcomes

  1. Changes of the microbiome

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2018
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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