Obesity, MorbidNCT03391817
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY
A study testing Fecal microbiota transplantation in people with Obesity, Morbid, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites in Finland.
Trial summary
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Fecal microbiota transplantation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesFinland
- Study dates
- 19 Jan 2018to 28 Feb 2021
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Candidates for the bariatric surgery
- BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
- Availability of consecutive fecal samples during one year
- Compliance to attend gastroscopy and FMT
- 18-65 years
Who cannot join
- Unable to provide informed consent
- Pregnancy
- Type I Diabetes Mellitus
- Severe renal insufficiency, GFR<30%
- Chronic or recurrent bacterial infection needing antimicrobial treatment
- Large hiatal hernia
Trial locations and contacts
2 sites in 1 country.
Finland2 sites, 2 recruiting
- Recruiting
Helsinki University Hospital
Helsinki
Perttu Lahtinen, MD, +358447195256, perttu.lahtinen@phhyky.fi
- Recruiting
Päijät-Häme Central Hospital
Lahti
Perttu Lahtinen, MD, +358447195256, perttu.lahtinen@phhyky.fi
About this study
Official title: FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.
- Conditions
- Obesity, Morbid
- Being tested
- Fecal microbiota transplantation
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantationOther
Fecal microbiota transplantation administered in gastroscopy
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Active comparator | Fecal transplant from a thin donor Receives: Other: Fecal microbiota transplantation |
| Placebo arm | Placebo comparator | Fecal transplant made from patients own feces Receives: Other: Fecal microbiota transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of weight
Measured: 1,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start19 Jan 2018
- Primary completion28 Feb 2021 (estimated)
- Study completion28 Feb 2021 (estimated)
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 Obesity, MorbidStudies 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
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health Care
- Sponsor type
- University, hospital or other
- Collaborators
- University of Helsinki, Helsinki University Central Hospital
- Responsible party
- Sponsor
- Investigators
- Perttu Arkkila, PhD MD, Study director, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391817
- Sponsor's protocol ID
- FMTOBE
- Status last verified
- Aug 2019
- First submitted
- 30 Dec 2017
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lahtinen P, Juuti A, Luostarinen M, Niskanen L, Liukkonen T, Tillonen J, Kossi J, Ilvesmaki V, Viljakka M, Satokari R, Arkkila P. Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247226. doi: 10.1001/jamanetworkopen.2022.47226.
PubMed 36525272
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY
- ClinicalTrials.gov ID
- NCT03391817
- Acronym / sponsor ID
- FMTOBE
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Joint Authority for Päijät-Häme Social and Health CareUniversity, hospital or other
- Collaborators
- University of Helsinki, Helsinki University Central Hospital
- Study start
- 19 Jan 2018 (actual)
- Primary completion
- 28 Feb 2021 (estimated)
- Study completion
- 28 Feb 2021 (estimated)
- First posted
- 5 Jan 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.
40 patients meeting the criteria for obesity surgery are enrolled. Fecal microbiota transplantation (FMT) will be administered in gastroscopy 6 months before obesity surgery. 20 of the patients will receive a fecal transplant of a thin donor and 20 will receive placebo - a transplant made of their on feces. Changes in weight, laboratory values, general well being and stool microbiota will be measured up to one year after the surgery; one and a half years after FMT. The hypothesis is that FMT and the change in gut microbiota will help to reduce and maintain lower weight.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Active comparator | Other: Fecal microbiota transplantationFecal transplant from a thin donor |
| Placebo arm | Placebo comparator | Other: Fecal microbiota transplantationFecal transplant made from patients own feces |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Candidates for the bariatric surgery
- BMI ≥ 40 or BMI ≥35 and at least two obesity-related co-morbidities such as type II diabetes (T2DM), hypertension, sleep apnea and other respiratory disorders, non-alcoholic fatty liver disease, osteoarthritis, lipid abnormalities, gastrointestinal disorders, or heart disease.
- Availability of consecutive fecal samples during one year
- Compliance to attend gastroscopy and FMT
- 18-65 years
Key exclusion criteria (6 listed)
- Unable to provide informed consent
- Pregnancy
- Type I Diabetes Mellitus
- Severe renal insufficiency, GFR<30%
- Chronic or recurrent bacterial infection needing antimicrobial treatment
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 transplantationFecal microbiota transplantation administered in gastroscopy | Other | Intervention arm, Placebo arm |
Primary outcome
Reduction of weight
Time frame: 1,5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Derived from this study: PubMed 36525272Lahtinen P, Juuti A, Luostarinen M, Niskanen L, Liukkonen T, Tillonen J, Kossi J, Ilvesmaki V, Viljakka M, Satokari R, Arkkila P. Effectiveness of Fecal Microbiota Transplantation for Weight Loss in Patients With Obesity Undergoing Bariatric Surgery: A Randomized Clinical Trial. JAMA Netw Open. 2022 Dec 1;5(12):e2247226. doi: 10.1001/jamanetworkopen.2022.47226.
- Individual participant dataSharing planned: Undecided
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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, PhD MD study director
Helsinki University Central Hospital
2 sites 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 in people with Obesity, Morbid, run by Joint Authority for Päijät-Häme Social and Health Care at 2 sites 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 6 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Lahtinen, MD (+358447195256, perttu.lahtinen@phhyky.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of weight (time frame: 1,5 years). 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 NCT03391817, 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 2019.