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

NCT03074227 | Unknown DMC

• 1 other identifier: FAIS2016
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency at t=12 weeks after the first faecal transplantation

  This will be assessed with the pain component of the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score. With 2 questions, the severity and frequency of the abdominal pain on the last 10 days is measured. The IBS-SSS is the only symptom severity scale that has been responsive to treatment effects. It has been recommended as the best instrument to obtain information on specific IBS related symptoms.

  T=12 weeks

Secondary Outcomes (9)

• Intra-individual changes in faecal gut microbiota composition

  At baseline, 6 weeks, 12 weeks, 6 months and 12 months after faecal transplantation

• Adverse events

  At t=3, t=6, t=12 and t=16 weeks, and t=6 and 12 months

• The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency

  At t=6 and t=12 months

• Total IBS-SSS score

  At baseline, t=3, t=6, t=12 and t=16 weeks, and t=6 and 12 months

• Health related quality of life

  baseline, t=6 and t=12 weeks, and t=6 and 12 months

Study Arms (2)

Allogeneic faecal transplantation

ACTIVE COMPARATOR

Faecal transplantation of donor stool

Other: Allogeneic faecal transplantation

Autologous faecal transplantation

PLACEBO COMPARATOR

Faecal transplantation of own stool

Other: Autologous faecal transplantation

Interventions

Allogeneic faecal transplantation OTHER

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.

Also known as: FMT

Allogeneic faecal transplantation

Autologous faecal transplantation OTHER

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.

Also known as: FMT

Autologous faecal transplantation

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients
• Age 16-21 years
• Non-smokers
• Ability to give informed consent
• Established irritable bowel syndrome diagnosis according to the Rome IV criteria for children or adults
• According to a recently published guideline by the Rome Foundation for the design of pharmacological clinical trials in adolescents, patients are required to have an average daily pain rate of at least 30mm on the pain component scale of the IBS-SSS
• Symptoms are present for ≥12 months
• The patient has received adequate explanation and reassurance for his/her symptoms
• Appropriate dietary interventions have occurred, including the normalisation of the insoluble fibre intake and a decrease in gas producing foods
• Absence of response to a minimum of six sessions of psychological treatment (i.e. cognitive behavioural therapy and/or hypnotherapy)
• Absence of response to an adequate dose of at least one IBS specific pharmacological agent tried for a minimum of 6 weeks (like Mebeverine or peppermint oil capsules)
• Donors
• Age ≥18 years
• Non-smokers
• Ability to give informed consent

You may not qualify if:

• Patients
• Current treatment by another health care professional for abdominal symptoms
• Known concomitant organic gastrointestinal disease
• Known diagnosis of inflammatory bowel disease (i.e. Crohns disease or ulcerative colitis)
• Known diagnosis of an autoimmune disease (e.g. hypo- or hyperthyroidism, celiac disease, rheumatoid arthritis)
• Known diagnosis of cystic fibrosis
• Known diagnosis of porphyria
• Current use of drugs which influence gastrointestinal motility, such as erythromycin, azithromycin, butyl scopolamine, domperidone, peppermint oil capsules, and Iberogast
• Known pregnancy or current lactation
• Condition leading to profound immunosuppression (HIV, infectious diseases leading to immunosuppression, bone marrow malignancies/use of systematic chemotherapy)
• Life expectancy \< 12 months
• Use of concomitant medication, including proton pomp inhibitors (PPI), with the exception of pain medication (pain medication in the form of Paracetamol or NSAIDs is allowed)
• Use of systemic antibiotics in preceding 6 weeks
• Use of probiotic treatment in preceding 6 weeks
• Positive stool cultures for Clostridium difficile, Helicobacter pylori

Sponsors & Collaborators

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

Study Sites (1)

AMC

Amsterdam, North Holland, 1105 AZ, Netherlands

RECRUITING

Related Publications (1)

• Zeevenhooven J, de Bruijn CMA, Vlieger A, Nieuwdorp M, Benninga MA. Protocol for a pilot randomised, double-blind, placebo-controlled trial for assessing the feasibility and efficacy of faecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: FAIS Trial. BMJ Paediatr Open. 2020 Aug 20;4(1):e000689. doi: 10.1136/bmjpo-2020-000689. eCollection 2020.

  PMID: 32864480 BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Marc Benninga, Prof.dr

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Judith Zeevenhooven, PhD

CONTACT

+31 20 5662906; j.zeevenhooven@amc.uva.nl

Marc Benninga, prof.dr

CONTACT

+31 20 5663351; m.a.benninga@amc.uva.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomised by a computerised random-number generator to one of the following two treatment arms: 1. allogeneic faecal infusions at t=0 and t=6. 2. autologous faecal infusions at t=0 and t=6. Randomisation and preparation of the faeces will be performed by one of the research assistants. He/she is the only person who will know which treatment the patient will be given and will have no role in further parts of the study. The randomisation list will be kept under secured access by the Clinical Research Unit of the AMC Amsterdam, who will perform the randomisation. In case of an emergency the study medication can be unblinded after consultation of the principal investigator.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.dr.

Model Details: Double-blind, randomised, placebo-controlled pilot study as well as a reversed translational part.

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 8, 2017
• Study Start: November 23, 2017
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: February 22, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)