Status:
UNKNOWN
Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity
Lead Sponsor:
University Hospital of North Norway
Collaborating Sponsors:
Norwegian University of Science and Technology
Lovisenberg Diakonale Hospital
Conditions:
Obesity, Morbid
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
This is a randomized, double-blinded and placebo controlled prospective trial with sixty patients to investigate the effect of fecal microbiota transplantation (FMT) on body weight in patients with se...
Detailed Description
Obesity is a main threat to public health in western countries. This condition increases the risk of developing type 2 diabetes, cardiovascular diseases, physical stress disorders, dispose for cancer ...
Eligibility Criteria
Inclusion
- BMI \> 40 or BMI \> 35 kg/m2 combined with comorbidity related to obesity.
Exclusion
- Symptomatic cardiovascular disease, lung disease, cirrhosis or significant renal failure.
- Patients who are pregnant or breastfeeding
- Patients who have a confirmed malignancy or cancer
- Patients who are immunocompromised
- Previous gastric or small intestinal surgery that alters gut anatomy such as fundoplication, gastric resection, gastric bypass, small bowel resection, and ileoectomy
- Established drug- or alcohol abuse or particularly unstable psychosocial circumstances.
- History of cholecystektomy (gut microbiota composition could be affected by bile acid composition)
- New drugs the last three months or during the follow-up period that can impact on metabolism or body weight
- Antibiotic treatment the last three months
Key Trial Info
Start Date :
May 13 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03273855
Start Date
May 13 2019
End Date
May 1 2023
Last Update
January 20 2023
Active Locations (1)
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1
University Hospital of North Norway
Harstad, Troms, Norway, 9406