NCT03691987CompletedPhase 2
The Comeback Study
Fecal Microbiota Transplantation in Chronic Fatigue Syndrome - an RCT
Source: ClinicalTrials.gov · Last updated 23 Feb 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 10 Sept 2018
- Start date
- 15 Feb 2019
- Primary completion date
- 1 Mar 2023
- Lead sponsor
- University Hospital of North Norway
- Diseases
- Long COVID and ME/CFS
- NCT number
- NCT03691987
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 80
- From 15 Feb 2019 to the primary completion date, 1 Mar 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Immuno-deficiency or use of immune-suppresive drugs
- Introduction of new food supplements, change in diet or introduction of new medications the last three months
- Previous treatment with FMT
- FMT DONORS
Other illness
- Kidney failure
- Congestive heart failure
- Other disease that may explain ME/CFS symptoms discovered during diagnostic work up
- Chronic infectious disease (HIV, hepatitis B or C etc.)
- History of abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy
- History of: -chronic diarrhea
- inflammatory bowel disease
- colorectal cancer
- Metabolic syndrome
- Atopic skin disease
- Psychiatric disorders
- Other serious autoimmune disease
- Close relatives with serious autoimmune disease
Other
- Use of antibiotics the last three months,
- Use of low dose naltrexone or Isoprinosin
- Pregnancy or breastfeeding
- Serious endogenous depression
- Assessed not be able to follow the instructions for data and sample collection
- Very severe ME/CFS (WHO class IV)
- Symptom duration of less than 24 months or more than 15 years
- Use of peroral antibiotics past 3 months
- Use of topical antibiotics past 2 months
- Tattoo or piercing past 6 months
- Former imprisonment
- constipation
- colorectal polyps
- immuno-suppression
- Obesity
- CFS/ME
- High risk sexual behavior
- Bowel movements that does not correspond to a Bristol Stool Scale type 3 or 4
- Journeys abroad the last six months to countries high in antibiotic resistance
- Use of food supplements, pre-, -pro, -or symbiotics past one month
- Dysbiosis grade 3 or more by the GA dysbiosis test
Who the study is looking for
- International Consensus Criteria for CFS/ME
- 18-65 years
- Mild-severe CFS/ME
- Fatigue Severity Scale score of 5,0-7,0
- Symptom duration for 2-15 years
- Healthy
- Age 16-30 years
- Type 3 or 4 stool by the Bristol Stool Scale
Criteria the registry did not label
- FMT PARTICIPANTS
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of North Norway, Harstad Coordinator of this site? Confirm its status | Harstad | Norway | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.