Irritable Bowel SyndromeFAISNCT03074227
The FAIS-Trial: Faecal Microbiota Transplantation (FMT) in Adolescents With Refractory Irritable Bowel Syndrome (IBS)
A study testing Allogeneic faecal transplantation and Autologous faecal transplantation in people with Irritable Bowel Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Allogeneic faecal transplantation and Autologous faecal transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Nov 2017to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
- BMI 18-25 kg/m2
- Regular stool pattern
Who cannot join
- 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
Show all 51Show fewer
- 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
- Positive Dual Faeces Test for Giardia lamblia, Dientamoeba fragilis, Entamoeba histolytica
- XTC, amphetamine or cocaine abuse
- History of surgery (hemicolectomy (defined as: surgery resulting in a resection of > 0.5 of the colon), presence of a pouch due to surgery, presence of stoma)
- Known intra-abdominal fistula
- Vasopressive medication, ICU stay
- Signs of ileus, diminished passage
- Allergy to macrogol or substituents, e.g. peanuts, shellfish
- Insufficient knowledge of the Dutch language
- Donors
- Abnormal bowel motions, abdominal complaints or symptoms indicative of irritable bowel syndrome
- An extensive travel behaviour
- Unsafe sex practice (questionnaire)
- Use of any medication including PPI
- Antibiotic treatment in the past 12 weeks
- A positive history/clinical evidence for inflammatory bowel disease (Crohns disease or ulcerative colitis) or other gastrointestinal diseases, including chronic diarrhoea or chronic constipation
- A positive history/clinical evidence for autoimmune disease (type 1 diabetes, Hashimoto hypothyroidism, Graves hyperthyroidism, rheumatoid arthritis, celiac disease) and/or patients receiving immunosuppressive medications
- History of or present known malignant disease and/or patients who are receiving systemic anti-neoplastic agents
- Known psychiatric disease (depression, schizophrenia, autism, Asperger's syndrome)
- Known chronic neurological/neurodegenerative disease (e.g. Parkinson's disease, multiple sclerosis)
- Predisposing factors for potential transmittable diseases (e.g. regular sexual contact with prostitutes/promiscuity)
- Positive blood tests for the presence of: HIV, HTLV, lues, Strongyloides, amoebiasis
- Active hepatitis A, B-, C- or E-virus infection or known exposure within recent 12 months, acute infection with cytomegalovirus (CMV) or Epstein-Barr virus (EBV)
- Positive faecal tests for the presence of:
- Bacteria (Clostridium difficile, Helicobacter pylori, Salmonella spp., Shigella spp., pathogenic Campylobacter spp., Yersinia enterocolitica, Aeromonas spp., Plesiomonas shigelloides, Antibiotic resistant bacteria: Extended spectrum beta-lactamase (ESBL)-producing Enterobactereacceae, VRE (vancomycin resistant enterococ)
- Viruses (faecal PCR-test: Norovirus Type I and II, Astrovirus, Sapovirus, Adenovirus type 40/41, Rotavirus, Enterovirus, Adenovirus non-41/41)
- Parasites (Giardia lamblia, Cryptosporidium spp., Entamoeba histolytica, Dientamoeba fragilis, Microsporidium spp., Blastocystis hominis, Isospora spp. Or more than 1 of the following non-pathogenic parasites: Entamoeba gingivalis, Entamoeba hartmanni, Entamoeba coli, Entamoeba polecki, Endolimax nana, Iodamoeba bütschlii, Entamoeba dispar, Entamoeba moshkovskii
- If a donor turns out positive for only 1 of the above mentioned non-pathogenic parasites, inclusion is acceptable
- o Parasitic worm eggs, larvae, protozoan cysts and oocysts
- Chronic pain syndromes (e.g. fibromyalgia)
- Major relevant allergies (e.g. food allergy, multiple allergies)
- Recent (gastrointestinal) infection (within last 6 months)
- Tattoo or body piercing placement within last 6 months
- Known risk of Creutzfeldt Jacobs disease
- History of current use of IV drugs
- History of treatment with growth factors
- Untreated infection with: Treponematoses, TBC, Herpes virus
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
AMC
Amsterdam, North Holland, 1105 AZ
Judith Zeevenhoven, Drs, +31205662906, j.zeevenhoven@amc.nl
Marc Benninga, Prof, +31205663351, m.a.benninmga@amc.nl
About this study
Official title: The FAIS-Trial: Faecal Transplantation in Adolescents With Refractory Irritable Bowel Syndrome
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.
Read the detailed description
Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal pain or discomfort associated with a change in stool form or frequency, in the absence of a biochemical or structural explanation for these symptoms. The prevalence of IBS in the general adult population is 9.8-12.8%, which is in accordance to the prevalence of IBS in children and adolescents (6.2%-11.9%). Patients with IBS report a decreased quality of life, high work or school absence, and are more at risk than healthy controls of developing depressive and anxiety disorders. Consequently, the healthcare costs are substantial; annual costs of care for adults with IBS in the USA are estimated to be over $20 billion. Total annual costs per paediatric IBS patient in the Netherlands are estimated to be €2500. Although the pathophysiology of IBS has not been fully elucidated, pathophysiological abnormal gastrointestinal motility, visceral hypersensitivity, altered brain-gut function, low-grade inflammation, psychosocial disturbance and intestinal microbiota characteristics have been proposed to contribute to the pathophysiology. Current treatment focuses on abnormal gastrointestinal motility, altered brain-gut function and psychosocial disturbances. However, a significant amount of IBS patients has remaining symptoms, despite these treatment regimens. These patients are considered to be therapy-resistant, also called refractory. Treatment focusing on other components of the underlying pathophysiology, such as the intestinal microbiota, might therefore lead to new therapeutic successes in this group of patients. In this light, being able to modify the intestinal microbiota inrefractory IBS patients could have beneficial effects on symptoms. Faecal transplantation, a relatively new treatment regimen that enables the modification of the microbiome, has been shown to be highly effective in treating Clostridium difficile infections and also yielded promising results in patients with other diseases such as diabetes.
Objective: 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.
Study design: Double-blind randomised placebo-controlled pilot study as well as a reversed translational part.
Study Population: Patients with refractory IBS, defined as a failure to improve after standard medical treatment, at least 6 sessions of a psychological therapy and absence of response to at least 1 pharmacological agent (aged 16-21 years, male/female, no concomitant medication, non-smoking), will be recruited by their (paediatric) gastroenterologist at the Academic Medical Centre (Amsterdam, the Netherlands) and patients from other hospitals will be enrolled. Donors: relatives or volunteers will serve as faeces donor, potential donors will be thoroughly screened.
Treatment: After bowel lavage with Klean-Prep, patients will be treated with faecal transplantation at t=0 and t=6 weeks, processed for duodenal tube infusion. Faeces will be collected from a healthy donor (allogeneic) as well as the patient him/herself (autologous), in which their own faeces will be used as a placebo.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Allogeneic faecal transplantation, Autologous faecal transplantation
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic faecal transplantationOther
Also called FMT
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.
Autologous faecal transplantationOther
Also called FMT
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.
| Study group | Role | What they receive |
|---|---|---|
| Allogeneic faecal transplantation | Active comparator | Faecal transplantation of donor stool Receives: Other: Allogeneic faecal transplantation |
| Autologous faecal transplantation | Placebo comparator | Faecal transplantation of own stool Receives: Other: Autologous faecal transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T=12 weeks
Secondary outcomes (9)
Intra-individual changes in faecal gut microbiota composition
To examine the changes in faecal microbiota composition in IBS patients following FMT. To assess faecal gut microbiota composition, morning stool samples will be collected. Samples will be taken by the patient him/herself (wearing gloves) and will be put in a small container. Afterwards it will directly be transported to the AMC, where all samples will be stored at -80°C. Faecal analysis will be done by HITChip flora mapping, an established sensitive RT-qPCR method which is developed for exact and sensitive enumeration of bacterial population.
Measured: At baseline, 6 weeks, 12 weeks, 6 months and 12 months after faecal transplantation
Adverse events
Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF.
Measured: 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
This will be assessed with the pain component of the Irritable Bowel Syndrome Severity Scoring System (IBS-SSS) score.
Measured: At t=6 and t=12 months
Total IBS-SSS score
In addition to the pain component of the IBS-SSS score, the total IBS-SSS score will be evaluated with the same interval.
Measured: At baseline, t=3, t=6, t=12 and t=16 weeks, and t=6 and 12 months
Health related quality of life
The IBS-QOL questionnaire will be used as the disease specific questionnaire. This questionnaire is a 34-item assessment of the degree to which the IBS interferes with patient quality of life and consists of eight domains: dysphoria, interference with activities, body image, health worry, food avoidance, social reactions, sexual health, and effect on relationships. For generic quality of life, the Medical Outcomes Study 36-item Short Form Health Survey (SF-36) will be used.The SF-36 questionnaire consists of 36 questions regarding eight dimensions of health perception: limitations in physical functioning, role limitation due to physical health problems, bodily pain, general health perception, vitality, social functioning, role limitations due to emotional limitations, and mental health. The reliability has been proven extensively for diverse patient groups and it is validated for the Dutch population.The SF-36 is described as adequate for persons 14 years of age and older.
Measured: baseline, t=6 and t=12 weeks, and t=6 and 12 months
Depression and anxiety
Depression and anxiety scores will be measured using the SCL-90. The SCL-90 is a widely used measure of psychological state, suitable for adolescents > 11 years and adults. It has question items that ask on a 5-point scale, how much a certain problem has bothered the subject over the past 7 days. This allows nine scales to be derived, namely somatisation, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, and psychoticism
Measured: baseline, t=6 and t=12 weeks, and t=6 and 12 months.
Absence of school or work, health care resources and costs
A self-designed questionnaire will be used to monitor school absence (adolescents) and absence from work during the first year after treatment.
Measured: baseline, t=6 and t=12 weeks, and t=6 and 12 months.
Adequate relief
Adequate relief will be measured using a single question ("Did you have adequate relief of IBS/FAP symptoms (abdominal discomfort/pain, bowel habits, and other symptoms like nausea and bloating) over the past week?") scored on a dichotomous scale (Yes/No). This instrument is a well-validated simple outcome assessment for IBS treatment.
Measured: t=6 and t=12 weeks, and t=6 and 12 months
Number of participants with treatment-related adverse events as assessed by CRP, liver profile and renal profile
CRP, liver profile and renal profile will be assessed.Therefore, 4 tubes of blood per assessment will be taken, with a total maximum amount of 20mL. Three of these tubes will be frozen and stored. In case certain biomarkers for inflammation or metabolites related to the gut-brain axis will be demonstrated in the next 5 years, the stored serum can be used for analysis of this newly discovered biomarkers or metabolites in irritable bowel syndrome.
Measured: t=0, t=6 and t=12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2017
- Study start23 Nov 2017
- Primary completion31 Aug 2022 (estimated)
- Study completion31 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind, randomised, placebo-controlled pilot study as well as a reversed translational part.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.A. Benninga, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Marc Benninga, Prof.dr, Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074227
- Sponsor's protocol ID
- FAIS2016
- Acronym
- FAIS
- Status last verified
- Feb 2022
- First submitted
- 28 Feb 2017
- Last updated
- 22 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32864480de Bruijn CMA, Oorthuys AOJ, Zeevenhooven J, Davids M, Levels JHM, Vlieger AM, Herrema H, Nieuwdorp M, Benninga MA. Feasibility and efficacy of fecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: A randomized clinical pilot trial. J Pediatr Gastroenterol Nutr. 2026 Jun 1. doi: 10.1002/jpn3.70459. Online ahead of print.
PubMed 42220281
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FAIS-Trial: Faecal Transplantation in Adolescents With Refractory Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT03074227
- Acronym / sponsor ID
- FAIS / FAIS2016
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 23 Nov 2017 (actual)
- Primary completion
- 31 Aug 2022 (estimated)
- Study completion
- 31 Aug 2022 (estimated)
- First posted
- 8 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Irritable bowel syndrome (IBS) is a chronic disorder characterized by abdominal pain or discomfort associated with a change in stool form or frequency, in the absence of a biochemical or structural explanation for these symptoms. The prevalence of IBS in the general adult population is 9.8-12.8%, which is in accordance to the prevalence of IBS in children and adolescents (6.2%-11.9%). Patients with IBS report a decreased quality of life, high work or school absence, and are more at risk than healthy controls of developing depressive and anxiety disorders. Consequently, the healthcare costs are substantial; annual costs of care for adults with IBS in the USA are estimated to be over $20 billion. Total annual costs per paediatric IBS patient in the Netherlands are estimated to be €2500. Although the pathophysiology of IBS has not been fully elucidated, pathophysiological abnormal gastrointestinal motility, visceral hypersensitivity, altered brain-gut function, low-grade inflammation, psychosocial disturbance and intestinal microbiota characteristics have been proposed to contribute to the pathophysiology. Current treatment focuses on abnormal gastrointestinal motility, altered brain-gut function and psychosocial disturbances. However, a significant amount of IBS patients has remaining symptoms, despite these treatment regimens. These patients are considered to be therapy-resistant, also called refractory. Treatment focusing on other components of the underlying pathophysiology, such as the intestinal microbiota, might therefore lead to new therapeutic successes in this group of patients. In this light, being able to modify the intestinal microbiota inrefractory IBS patients could have beneficial effects on symptoms. Faecal transplantation, a relatively new treatment regimen that enables the modification of the microbiome, has been shown to be highly effective in treating Clostridium difficile infections and also yielded promising results in patients with other diseases such as diabetes.
Objective: 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.
Study design: Double-blind randomised placebo-controlled pilot study as well as a reversed translational part.
Study Population: Patients with refractory IBS, defined as a failure to improve after standard medical treatment, at least 6 sessions of a psychological therapy and absence of response to at least 1 pharmacological agent (aged 16-21 years, male/female, no concomitant medication, non-smoking), will be recruited by their (paediatric) gastroenterologist at the Academic Medical Centre (Amsterdam, the Netherlands) and patients from other hospitals will be enrolled. Donors: relatives or volunteers will serve as faeces donor, potential donors will be thoroughly screened.
Treatment: After bowel lavage with Klean-Prep, patients will be treated with faecal transplantation at t=0 and t=6 weeks, processed for duodenal tube infusion. Faeces will be collected from a healthy donor (allogeneic) as well as the patient him/herself (autologous), in which their own faeces will be used as a placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomised, placebo-controlled pilot study as well as a reversed translational part.
| Arm | Type | Receives |
|---|---|---|
| Allogeneic faecal transplantation | Active comparator | Other: Allogeneic faecal transplantationFaecal transplantation of donor stool |
| Autologous faecal transplantation | Placebo comparator | Other: Autologous faecal transplantationFaecal transplantation of own stool |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- 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
Key exclusion criteria (51 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic faecal transplantationAlso: FMTPatients 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 | Allogeneic faecal transplantation |
| Autologous faecal transplantationAlso: FMTPatients 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. | Other | Autologous faecal transplantation |
Primary outcome
The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency at t=12 weeks after the first faecal transplantation
Time frame: T=12 weeks
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.
9 secondary outcomes
Intra-individual changes in faecal gut microbiota composition
Time frame: At baseline, 6 weeks, 12 weeks, 6 months and 12 months after faecal transplantation
Adverse events
Time frame: 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
Time frame: At t=6 and t=12 months
Total IBS-SSS score
Time frame: At baseline, t=3, t=6, t=12 and t=16 weeks, and t=6 and 12 months
Health related quality of life
Time frame: baseline, t=6 and t=12 weeks, and t=6 and 12 months
Depression and anxiety
Time frame: baseline, t=6 and t=12 weeks, and t=6 and 12 months.
Absence of school or work, health care resources and costs
Time frame: baseline, t=6 and t=12 weeks, and t=6 and 12 months.
Adequate relief
Time frame: t=6 and t=12 weeks, and t=6 and 12 months
Number of participants with treatment-related adverse events as assessed by CRP, liver profile and renal profile
Time frame: t=0, t=6 and t=12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2022.
- Background: PubMed 32864480Zeevenhooven 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.
- Derived from this study: PubMed 42220281de Bruijn CMA, Oorthuys AOJ, Zeevenhooven J, Davids M, Levels JHM, Vlieger AM, Herrema H, Nieuwdorp M, Benninga MA. Feasibility and efficacy of fecal microbiota transplantation in adolescents with refractory irritable bowel syndrome: A randomized clinical pilot trial. J Pediatr Gastroenterol Nutr. 2026 Jun 1. doi: 10.1002/jpn3.70459. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Benninga, Prof.dr principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Allogeneic faecal transplantation and Autologous faecal transplantation in people with Irritable Bowel Syndrome, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 51 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith Zeevenhooven, PhD (+31 20 5662906, j.zeevenhooven@amc.uva.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of patients with > 50% reduction of their abdominal pain intensity and pain frequency at t=12 weeks after the first faecal transplantation (time frame: T=12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074227, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2022.