Irritable Bowel SyndromeFinFMT-IBSNCT05361785
Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
A study testing FMT in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, run by Helsinki University Central Hospital at 1 site in Finland.
Trial summary
Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome, Fecal Microbiota Transplantation
- What is being tested?
- FMT
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- 30 Apr 2022to 31 Jul 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults, age 18-75 years, knowledge of the Finnish language
- IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
- The patient must consume low FODMAP diet to control IBS symptoms
- Patient must sign the informed consent
Who cannot join
- Diagnosed allergies to food components in the study dietary protocol
- Pregnancy and breastfeeding
- Antibiotic treatment less than three months prior enrolment
- Faecal incontinence, i.e., inability to retain enema
- Abuse of drugs, alcohol or medications
- Other diagnosis besides IBS causing GI symptoms, these include IBD, microscopic colitis, coeliac disease and bile acid diarrhoea.
- Severe psychiatric or neurologic condition decreasing patient's compliance
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Helsinki University Hospital
Helsinki, Helsinki and Uusimaa, 00290
Perttu Arkkila, Professor, +358504272272 ext. +35894711, perttu.arkkila@hus.fi
Perttu Arkkila, Md., +358381911 ext. +35838192323, perttu.lahtinen@phhyky.fi
About this study
Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.
The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.
Read the detailed description
This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..
- Being tested
- FMT
- Keywords
- FMT, IBS, FODMAP
- 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.
FMTBiological
FMT from healthy donor or placebo
| Study group | Role | What they receive |
|---|---|---|
| FMT form healthy donor | Active comparator | FMT from healthy donor Receives: Biological: FMT |
| FMT plasebo | Placebo comparator | FMT plasebo Receives: Biological: FMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet
With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.
Measured: FMT and IBS
Secondary outcomes (2)
Microbial components explaining the successful broadening of FODMAP diet in IBS patients.
We aim to investigate what are the microbial components explaining the successful broadening of their diet and identify microbial taxa engrafted from the donor explaining the dietary modifications.
Measured: Microbiome and FODMAP
GI symptoms and bacterial fermentaiton status in IBS
Aim to investigate the gastrointestinal symptom change and see how changes in bacterial fermentation status (detected with hydrogen breath test) modulates the patients' symptoms and if this is related to the FMT treatment.
Measured: Bacterial fermentation status and IBS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2022
- Study start30 Apr 2022
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Helsinki University Central HospitalThe 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
- Single group
- Model description
- RCT, randomaization 2/3 FMT, 1/3 placebo
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helsinki University Central Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Turku University Hospital, University of Helsinki, Paijat-Hame Hospital District
- Responsible party
- Principal investigator, Perttu Arkkila, Helsinki University Central Hospital
- Investigators
- Perttu Arkkila, Professor, Principal investigator, Head physicianPerttu Lahtinen, Md., Study chair, Head physician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05361785
- Sponsor's protocol ID
- 1480/2021
- Acronym
- FinFMT-IBS
- Status last verified
- May 2022
- First submitted
- 30 Apr 2022
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pseudoanonymous data is available to other reserchers
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for Irritable Bowel Syndrome Associated Food Intolerance
- ClinicalTrials.gov ID
- NCT05361785
- Acronym / sponsor ID
- FinFMT-IBS / 1480/2021
- Keywords
- FMT, IBS, FODMAP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Helsinki University Central HospitalUniversity, hospital or other
- Collaborators
- Turku University Hospital, University of Helsinki, Paijat-Hame Hospital District
- Study start
- 30 Apr 2022 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 5 May 2022 (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.
Previous studies have shown that stool transplantation (FMT) have positive effect in symptoms for some patients with irritable bowel syndrome (IBS). Studies have shown that it is possible by FMT to reverse the microbiome of the recipient's intestine in the direction of the microbiome of the donor. The effect on eating habits for engraftment of microbiome by FMT is unknown.
The purpose of this study is to investigate whether FMT relieves FODMAP diet extension without worsening intestinal symptoms in IBS patients.
Detailed description
This is a plasebo controlled study in which we study the effect and safety of FMT in patients who have IBS and have used FODMAP diet. FMT is assessed by colonoscopy route and therafter the patietns receive twice FMT enema from healthy donor or plasebo..
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- RCT, randomaization 2/3 FMT, 1/3 placebo
| Arm | Type | Receives |
|---|---|---|
| FMT form healthy donor | Active comparator | Biological: FMTFMT from healthy donor |
| FMT plasebo | Placebo comparator | Biological: FMTFMT plasebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults, age 18-75 years, knowledge of the Finnish language
- IBS patients have been diagnosed with the Rome IV- criteria, all IBS-subtypes will be accepted to the trial
- The patient must consume low FODMAP diet to control IBS symptoms
- Patient must sign the informed consent
Key exclusion criteria (7 listed)
- Diagnosed allergies to food components in the study dietary protocol
- Pregnancy and breastfeeding
- Antibiotic treatment less than three months prior enrolment
- Faecal incontinence, i.e., inability to retain enema
- Abuse of drugs, alcohol or medications
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 |
|---|---|---|
| FMTFMT from healthy donor or placebo | Biological | FMT form healthy donor, FMT plasebo |
Primary outcome
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet
Time frame: FMT and IBS
With this study we aim to investigate if FMT treatment promotes inclusion and tolerance of FODMAPs in the IBS patients' diet.
2 secondary outcomes
Microbial components explaining the successful broadening of FODMAP diet in IBS patients.
Time frame: Microbiome and FODMAP
GI symptoms and bacterial fermentaiton status in IBS
Time frame: Bacterial fermentation status and IBS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Individual participant dataSharing planned: Yes. Pseudoanonymous data is available to other reserchers
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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.
Perttu Arkkila, Professor principal investigator
Head physician
Perttu Lahtinen, Md. study chair
Head physician
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FMT in people with Irritable Bowel Syndrome and Fecal Microbiota Transplantation, run by Helsinki University Central Hospital at 1 site in Finland.
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 4 inclusion and 7 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 13 May 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 Finland. 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 Perttu Arkkila, Professor (+358504272272 ext. +35894, perttu.arkkila@hus.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of FMT for tolerance of FODMAPs in the IBS patients' diet (time frame: FMT and IBS). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2022.