Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity

NCT ID: NCT03273855

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-13
• Study Completion Date: 2023-05-01

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

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 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.

Conditions

Obesity, Morbid

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Active Comparator. Transplant from Donor A or Donor B, or Donor C or Donore D, one transplant consist of 50-80g of feacal matter.

Group Type: ACTIVE_COMPARATOR

Fecal microbiota transplantation

Intervention Type: OTHER

The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.

Placebo

Placebo. Patient will recieve an autologous fecal microbiota transplantation.

Group Type: PLACEBO_COMPARATOR

Placebo: fecal microbiota transplantation

Intervention Type: OTHER

The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.

Interventions

Fecal microbiota transplantation

The intervention treatment is fecal microbiota transplantation made of frozen donor feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.

Intervention Type: OTHER

Placebo: fecal microbiota transplantation

The placebo group get fecal microbiota transplantation made of their own feces. The FMT is transferred as rectal enema where we use a rectal probe with a balloon to prevent leakage and keep the solution long enough in the colon. The patient will stay on the bench in different positions for 20 minutes. We will encourage the participant to keep the solution in the colon as long as possible and give them four pills of loperamide before the procedure in order to reduce bowel motility.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

Lovisenberg Diakonale Hospital

OTHER

Sponsor Role: collaborator

Nordlandssykehuset HF

OTHER

Sponsor Role: collaborator

Helse Nord

INDUSTRY

Sponsor Role: collaborator

University of Tromso

OTHER

Sponsor Role: collaborator

Norwegian University of Life Sciences

OTHER

Sponsor Role: collaborator

University of Oslo

OTHER

Sponsor Role: collaborator

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Per C Valle, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital of North of Norway

Maria S Fjellstad, cand.med

Role: STUDY_CHAIR

University Hospital of North of Norway

Hege M Hanssen, M.Sc

Role: STUDY_CHAIR

University Hospital of North Norway

Locations

University Hospital of North Norway

Harstad, Troms, Norway

Countries

Norway

References

Hanssen HM, Fjellstad MS, Skjevling L, Johnsen PH, Kulseng B, Goll R, Alma KH, Valle PC. Randomised, placebo-controlled, double-blinded trial of fecal microbiota transplantation in severe obesity: a study protocol. BMJ Open. 2023 Dec 27;13(12):e073242. doi: 10.1136/bmjopen-2023-073242.

Reference Type: DERIVED

PMID: 38151280 (View on PubMed)

Other Identifiers

2017/1655

Identifier Type: -

Identifier Source: org_study_id