Irritable Bowel SyndromeFMT-IBSNCT03561519
FMT in the Treatment of IBS
A study testing Fecal Microbiota Transplantation (FMT) in people with Irritable Bowel Syndrome, run by Joint Authority for Päijät-Häme Social and Health Care at 1 site in Finland.
Trial summary
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fecal Microbiota Transplantation (FMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteFinland
- Study dates
- 27 Aug 2015to 1 Jul 2018
- 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
- Diagnosis of IBS based on Rome III criteria
- Having received traditional treatment for at least 1 month
- Availability of consecutive fecal samples over one year.
- Compliance to attend ileocolonoscopy and FMT procedure.
- 18-75 years
Who cannot join
- Unable to provide informed consent
- Antibiotic therapy in past 3 months
- Inflammatory bowel disease (IBD)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.
Read the detailed description
52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fecal Microbiota Transplantation (FMT), Placebo
- 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.
Fecal Microbiota Transplantation (FMT)Other
Fecal suspension administered in colonoscopy into the cecum of the patient.
PlaceboOther
As a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy.
| Study group | Role | What they receive |
|---|---|---|
| FMT | Active comparator | IBS patients randomized to receive FMT from a healthy donor. Receives: Other: Fecal Microbiota Transplantation (FMT) |
| Placebo | Placebo comparator | IBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
IBS symptom relieve
Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2018
- Study start27 Aug 2015
- Primary completion1 Jul 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- 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
- Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki
- Responsible party
- Sponsor
- Investigators
- Perttu Arkkila, Adj. Prof., Study chair, +358 9 4711
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03561519
- Sponsor's protocol ID
- 40/13/03/01/15
- Acronym
- FMT-IBS
- Status last verified
- Jun 2018
- First submitted
- 6 Jun 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared.
Publications
Lahtinen P, Jalanka J, Hartikainen A, Mattila E, Hillila M, Punkkinen J, Koskenpato J, Anttila VJ, Tillonen J, Satokari R, Arkkila P. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. 2020 Jun;51(12):1321-1331. doi: 10.1111/apt.15740. Epub 2020 Apr 28.
PubMed 32343000
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF IRRITABLE BOWEL SYNDROME
- ClinicalTrials.gov ID
- NCT03561519
- Acronym / sponsor ID
- FMT-IBS / 40/13/03/01/15
- Conditions
- Irritable Bowel Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- Helsinki University Central Hospital, University of Helsinki
- Study start
- 27 Aug 2015 (actual)
- Primary completion
- 1 Jul 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 19 Jun 2018 (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.
52 adult IBS patients were recruited. 50% were given a fecal microbiota transplantation in colonoscopy and 50% were given an FMT made of their own feces as placebo. follow up time was 1 year after FMT.
Detailed description
52 adult IBS patients of any subgroup(IBS-D, IBS-C or IBS-M), were recruited and given an FMT in colonoscopy. Neither the patient nor the care taking personnel did know in which group the patients belonged to. The patients were screened with fecal samples for 16RNA sequencing and they were repeatedly done IBS-SSS questionnaire and questionnaires for quality of life and psychical condition. Follow up time was 1 year after the colonoscopy.
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
- Placebo controlled trial. 50% of patients received autologous FMT as placebo and 50% received FMT from a healthy donor.
| Arm | Type | Receives |
|---|---|---|
| FMT | Active comparator | Other: Fecal Microbiota Transplantation (FMT)IBS patients randomized to receive FMT from a healthy donor. |
| Placebo | Placebo comparator | Other: PlaceboIBS patients randomized to receive autologous FMT (fecal suspension made of their own feces) as a placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of IBS based on Rome III criteria
- Having received traditional treatment for at least 1 month
- Availability of consecutive fecal samples over one year.
- Compliance to attend ileocolonoscopy and FMT procedure.
- 18-75 years
Key exclusion criteria (3 listed)
- Unable to provide informed consent
- Antibiotic therapy in past 3 months
- Inflammatory bowel disease (IBD)
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 |
|---|---|---|
| Fecal Microbiota Transplantation (FMT)Fecal suspension administered in colonoscopy into the cecum of the patient. | Other | FMT |
| PlaceboAs a placebo a fecal suspension made of patients own feces is administered into the cecum of the patient in colonoscopy. | Other | Placebo |
Primary outcome
IBS symptom relieve
Time frame: 52 weeks
Reduction IBS-SSS by 50 points, The irritable bowel severity score system in which the maximum achievable score is 500. Mild, moderate and severe cases are indicated by scores of 75 to 175, 175 to 300 and > 300.( Aliment Pharmacol Ther. 1997 Apr;11(2):395-402.)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
- Derived from this study: PubMed 32343000Lahtinen P, Jalanka J, Hartikainen A, Mattila E, Hillila M, Punkkinen J, Koskenpato J, Anttila VJ, Tillonen J, Satokari R, Arkkila P. Randomised clinical trial: faecal microbiota transplantation versus autologous placebo administered via colonoscopy in irritable bowel syndrome. Aliment Pharmacol Ther. 2020 Jun;51(12):1321-1331. doi: 10.1111/apt.15740. Epub 2020 Apr 28.
- Individual participant dataSharing planned: No. Individual participant data will not be shared.
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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, Adj. Prof. study chair
+358 9 4711
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation (FMT) in people with Irritable Bowel Syndrome, run by Joint Authority for Päijät-Häme Social and Health Care 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 15 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IBS symptom relieve (time frame: 52 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 NCT03561519, which also lists 1 linked publication.
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 15 Aug 2018.