Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity (RCTFMTOb)

University Hospital of North Norway

Status

Invitation-only

Conditions

Obesity, Morbid

Treatments

Other: Fecal microbiota transplantation

Other: Placebo: fecal microbiota transplantation

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03273855

2017/1655

Details and patient eligibility

About

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 severe obesity. We will also collect data that possibly could give a better understanding of mechanisms of this correlation.

Full 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 and contributes to increased overall morbidity and mortality. However sustained weight loss lead to the reduction of risk factors and improvement of several obesity related co-morbidities.

Currently there are mainly two established treatments for severe obesity: a conservative approach through lifestyle intervention and a surgical approach with bariatric surgery. The gut microbiota is recognized as an environmental modulator of nutritional uptake and body weight. This has led to the hypothesis that the gut microbiota could be a therapeutic target fighting obesity. Fecal microbiota transplantation (FMT) has been applied for more than 50 years, and is a established treatment for refractory recurrent infection with Clostridium Difficile (CDI). Recent scientific studies have also applied FMT as treatment for other diseases like inflammatory bowel disease, irritable bowel disease and even metabolic syndrome and the results are promising.

The sample size is determined based on data from the outpatient clinic at UNN Harstad medical department. Patients here have an average weight loss of 2,5 % with conservative treatment. This will therefore be the expected result in the control group (receiving placebo). A weight reduction of 5-10% leads to significant improvement of health and quality of life, and a weight change of this magnitude is therefore the hypothesis. The difference between the two groups is estimated to 7,5 %. With these historical results, the sample size is estimated to be 19 patients in each group. Extreme values will be eliminated; more than 3 SD out of the average in the group. In this patient group, we must also be prepared to high degree loss of follow-up near one third, which is also the experience from the clinic. We will include totally 60 patients, 30 in each group.

The investigators are planning 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 severe obesity. In the trial there will also be collected data that possibly could give a better understanding of mechanisms of this correlation; with insulin resistance, blood pressure, complete body scan, inflammation and biochemical parameters of hepatic steatosis, changes in the patients microbiota and the development in quality of life as secondary outcome measures.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

BMI > 40 or BMI > 35 kg/m2 combined with comorbidity related to obesity.

Exclusion criteria

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