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The FAIS-Trial: Faecal Microbiota Transplantation (FMT) in Adolescents With Refractory Irritable Bowel Syndrome (IBS)

NCT03074227 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-02-22

No results posted yet for this study

Summary

A Double-blind randomised placebo-controlled pilot study as well as a reversed translational part To investigate whether two faecal transplantations from either allogeneic (healthy) or autologous (own) donor, administered through a nasoduodenal tube, has beneficial effects on irritable bowel syndrome (IBS) symptoms such as abdominal pain frequency and severity. Secondary objective is to study microbiota changes in faeces samples.

Conditions

  • Irritable Bowel Syndrome

Interventions

OTHER

Allogeneic faecal transplantation

Patients will get bowel lavage through a nasoduodenal tube. This bowel lavage consists of 2-3 litres of macrogol electrolytes (Klean-Prep) solution. After that, patients will be treated with allogeneic faecal microbiota transplantation via the nasoduodenal tube. Faeces will be collected from a donor.

OTHER

Autologous faecal transplantation

Patients will get bowel lavage through a nasoduodenal tube at our centre. This bowel lavage consists of 2-3 litres of macrogol electrolytes (Klean-Prep) solution. After that, patients will be treated with autologous faecal microbiota transplantation via the nasoduodenal tube.Faeces will be collected from the patient him/herself, in which their own faeces (autologous) will be used as a placebo.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Marc Benninga, Prof.dr · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-23
Primary Completion
2022-08-31
Completion
2022-08-31

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03074227 on ClinicalTrials.gov