Randomized Controlled Trial of Fecal Microbiota Transplantation in Severe Obesity

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.

Conditions

• Obesity, Morbid

Interventions

OTHER

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.

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.

Sponsors & Collaborators

• Norwegian University of Science and Technology

  collaborator OTHER

• Lovisenberg Diakonale Hospital

  collaborator OTHER

• Nordlandssykehuset HF

  collaborator OTHER

• Helse Nord

  collaborator INDUSTRY

• University of Tromso

  collaborator OTHER

• Norwegian University of Life Sciences

  collaborator OTHER

• University of Oslo

  collaborator OTHER

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Per C Valle, PhD · University Hospital of North of Norway

• Maria S Fjellstad, cand.med · University Hospital of North of Norway

• Hege M Hanssen, M.Sc · University Hospital of North Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

69 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-13

Primary Completion

2023-05-01

Completion

2023-05-01

Countries

• Norway

Study Locations