Status:
UNKNOWN
FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY
Lead Sponsor:
Joint Authority for Päijät-Häme Social and Health Care
Collaborating Sponsors:
University of Helsinki
Helsinki University Central Hospital
Conditions:
Obesity, Morbid
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 r...
Eligibility Criteria
Inclusion
- • 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
- 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
Key Trial Info
Start Date :
January 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2021
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03391817
Start Date
January 19 2018
End Date
February 28 2021
Last Update
August 15 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Helsinki University Hospital
Helsinki, Finland
2
Päijät-Häme Central Hospital
Lahti, Finland