- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03391817
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY
August 14, 2019 updated by: Joint Authority for Päijät-Häme Social and Health Care
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Perttu Lahtinen, MD
- Phone Number: +358447195256
- Email: perttu.lahtinen@phhyky.fi
Study Locations
-
-
-
Helsinki, Finland
- Recruiting
- Helsinki University Hospital
-
Contact:
- Perttu Lahtinen, MD
- Phone Number: +358447195256
- Email: perttu.lahtinen@phhyky.fi
-
Lahti, Finland
- Recruiting
- Päijät-Häme Central hospital
-
Contact:
- Perttu Lahtinen, MD
- Phone Number: +358447195256
- Email: perttu.lahtinen@phhyky.fi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
• 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Intervention arm
Fecal transplant from a thin donor
|
Fecal microbiota transplantation administered in gastroscopy
|
Placebo Comparator: Placebo arm
Fecal transplant made from patients own feces
|
Fecal microbiota transplantation administered in gastroscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Reduction of weight
Time Frame: 1,5 years
|
1,5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Perttu Arkkila, PhD MD, Helsinki University Central Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 19, 2018
Primary Completion (Anticipated)
February 28, 2021
Study Completion (Anticipated)
February 28, 2021
Study Registration Dates
First Submitted
December 30, 2017
First Submitted That Met QC Criteria
December 30, 2017
First Posted (Actual)
January 5, 2018
Study Record Updates
Last Update Posted (Actual)
August 15, 2019
Last Update Submitted That Met QC Criteria
August 14, 2019
Last Verified
August 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- FMTOBE
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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