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Stability of the Microbiome in IBD and IBS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03395548
Recruitment Status : Recruiting
First Posted : January 10, 2018
Last Update Posted : October 3, 2018
Sponsor:
Information provided by (Responsible Party):
Medical University of Graz

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 Not Applicable

Detailed Description:
I

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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 : August 25, 2017
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : July 1, 2020

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03395548


Contacts
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Contact: Andreas Blesl, MD 004338580989 andreas.blesl@medunigraz.at
Contact: Christoph Hoegenauer, Prof. christoph.hoegenauer@medunigraz.at

Locations
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Austria
Universitätsklinikum Graz Recruiting
Graz, Styria, Austria, 8010
Contact: Andreas Blesl, MD    004338580989    andreas.blesl@medunigraz.at   
Sponsors and Collaborators
Medical University of Graz
Investigators
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Principal Investigator: Andreas Blesl, MD Medical University of Graz
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Responsible Party: Medical University of Graz
ClinicalTrials.gov Identifier: NCT03395548    
Other Study ID Numbers: 29-255 ex 16/17
First Posted: January 10, 2018    Key Record Dates
Last Update Posted: October 3, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No