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Effects of bowel lavage on engraftment in irratble bowel patients treated with fecal microbiota transplantation

Effects of bowel lavage on engraftment in irratble bowel patients treated with fecal microbiota transplantation - ENT-Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48544
Enrollment
24
Registered
2018-08-09
Start date
2019-04-23
Completion date
Unknown
Last updated
2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IBS Irritable Bowel Syndrome

Interventions

IBS patients will be treated with FMT to assess the difference in engraftment in patients pre-treated with bowel lavage (conventional arm) compared to patients not pre-treated with bowel lavage (exp

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria: 1. Post-infectious or post antibiotic use IBS, IBS defined by the ROME IV criteria 2. 18 years or older 3. Provide informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1. Swallowing disorders, 2. Pregnancy, 3. Antibiotics use during study or shortly prior to start of study 4. Need for chemotherapy 5. ICU-admission 6. IBD / Celiac Disease 7. Severe immunecompromisation

Design outcomes

Primary

MeasureTime frame
Main study endpoint: the level of engraftment of donor microbiota in experimental and control patients. Resemblance between donor and recipient microbiota profile post-FMT will be assessed with IS-PRO technique, this is defined as engraftment.

Secondary

MeasureTime frame
Secondary endpoint: changes in microbiota post-FMT. The will be assessed with the IS-PRO technique. Secondary endpoint: changes in scores on IBS questionnaire post FMT compared to baseline questionnaire score

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)