The Comeback Study

Summary

This is a single-center stratified (on gender and donor), block randomized, placebo-controlled, parallel group trial with 12-months follow-up of 80 chronic fatigue syndrome/encephalomyelitis (CFS/ME) participants. Participants will be randomized to treatment by preprocessed thawed donor fecal microbiota transplant or preprocessed thawed autologous fecal microbiota transplant. Primary endpoint is the efficacy of FMT at three months by the Fatigue Severity Scale. The investigators will use patient reported outcomes for primary and secondary outcome measures.

Previous studies suggest that a dysbiosis of the gut microbiota may be a key feature in CFS/ME. We hypothesize that

A: CFS/ME is caused by a dysbiosis in the gut flora causing barrier leakage of bacterial products, a low grade systemic immune activation and disturbances in the host energy metabolism.

B: Recovery of a normal gut flora by fecal microbiota transplantation (FMT) alleviates symptoms and may even induce remission of CFS/ME.

This project aims to determine if there is a true cause and effect relationship between a dysbiotic gut flora and CFS/ME by testing if treatment of the observed dysbiosis by FMT also can resolve CFS/ME symptoms. In this process, collection of blood, fecal, and urine samples before and after FMT will open the possibility to explore the relationship between the gut flora, immune response, host energy metabolism and CFS/ME using technologies of microbiomics, metabolomics and immunological characterizations for a better understanding of the pathobiology of CFS/ME.

Conditions

• Chronic Fatigue Syndrome
• Myalgic Encephalomyelitis

Interventions

BIOLOGICAL

Preprocessed thawed donor FMT

Delivered as an enema using the same equipment and technique as X-ray of the colon

BIOLOGICAL

Preprocessed thawed autologous FMT

Delivered as an enema using the same equipment and technique as X-ray of the colon

Sponsors & Collaborators

• The Research Council of Norway

  collaborator OTHER

• Quadram Institute Bioscience

  collaborator OTHER

• Umeå University

  collaborator OTHER

• Cornell University

  collaborator OTHER

• University Hospital of North Norway

  lead OTHER

Principal Investigators

• Rasmus Goll, MD. PhD. · University Hospital of North Norway

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-02-15

Primary Completion

2023-03-01

Completion

2023-12-31

Countries

• Norway

Study Locations