Stability of the Microbiome in IBD and IBS

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)

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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