FAECAL MICROBIOTA TRANSPLANTATION IN OBESITY

Obesity, Morbid Clinical Trial

Official title:

FAECAL MICROBIOTA TRANSPLANTATION IN THE TREATMENT OF MORBID OBESITY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03391817
• Other study ID #: FMTOBE
• Status: Recruiting
• Phase: N/A
• Start date: January 19, 2018
• Est. completion date: February 28, 2021

Study information

• Verified date: August 2019
• Source: Joint Authority for Päijät-Häme Social and Health Care
• Contact: Perttu Lahtinen, MD
• Phone: +358447195256
• Email: perttu.lahtinen[@]phhyky.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: February 28, 2021
• Est. primary completion date: February 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Other:
• Fecal microbiota transplantation
Fecal microbiota transplantation administered in gastroscopy

Locations

Country	Name	City	State
Finland	Helsinki University Hospital	Helsinki
Finland	Päijät-Häme Central Hospital	Lahti

Sponsors (3)

Lead Sponsor	Collaborator
Joint Authority for Päijät-Häme Social and Health Care	Helsinki University, Helsinki University Central Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of weight		1,5 years