A Phase 2 interventional study of Preprocessed thawed donor FMT and Preprocessed thawed autologous FMT in Chronic Fatigue Syndrome and Myalgic Encephalomyelitis, sponsored by University Hospital of North Norway. Completed at 1 site in Norway. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-02-23.
Sponsored by University Hospital of North Norway · Phase 2, Interventional, and Treatment
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Among 25 studies in Fatigue Syndrome, Chronic with a site in Norway — 2 open to participants now, 2 under way, none of them phase 3. Fatigue Syndrome, Chronic · Norway.
Among the 25 studies in Fatigue Syndrome, Chronic with a site in Norway, this one is the 8th largest by enrollment of the 20 interventional ones that give a count, is one of 2 that started in 2019, is one of 6 in phase 2, and was the 20th registered.
264 studies on the registry are indexed under Fatigue Syndrome, Chronic; 62 are open to participants now.
Browse Fatigue Syndrome, Chronic studies →2 of the 25 studies in Fatigue Syndrome, Chronic with a site in Norway are open now. Recruiting first, the newest first:
Helse Stavanger HF · Sites in Norway
Ages 19–80 · Women only · Healthy volunteers
Norwegian University of Science and Technology · Sites in Norway
Ages 18–65
A study can be open while its sites in Norway have not opened yet or have stopped. Only those recruiting at a site in Norway →
Of the 44 Fatigue Syndrome, Chronic studies recruiting now, 18 (41%) set no upper age limit and 20 (45%) stop at 75 or younger; 5 take children under 18; 10 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
25 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 7 · Phase 3 2 · Phase 4 1
First in 2008; this study’s year is marked. 2 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 80 is above the median of 60 across 178 interventional studies indexed under Fatigue Syndrome, Chronic.
Median enrollment 45 across the 20 interventional studies, 90 across the 5 observational. Of the 23 that completed or were terminated, 0 (0%) have results posted.
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None of the 25 has an industry lead sponsor. The 9 most frequent:
University Hospital of North Norway is the lead sponsor of 152 studies on the registry; 24 are open to participants now.
University Hospital of North Norway has 1 study filed under Fatigue Syndrome, Chronic — fewer than ten, so there is no comparison to draw.
1 of the studies in Fatigue Syndrome, Chronic with a site in Norway that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05236465Norwegian University of Science and TechnologyA 3-day Course for CFS/ME | 2027-01-01 |
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Among the 25 studies in Fatigue Syndrome, Chronic with a site in Norway, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
CFS/ME participants:
General practitioners recruit participants from the local area, by posters at the doctors' offices. In addition the study has a facebook site, named "the COMEBACK study", where interested CFS/ME subjects can submit their interest to be assessed for participation. After a telephone screening of potential participants by the International Consensus Criteria for CFS/ME and CFS/ME severity rating, eligible subjects will be referred to department of physical medicine and rehabilitation UNN Harstad (FYSMED) and re-assessed. During this screening process the investigators will keep a track record of screening failures noting reason for failure. Participants will have a physical exam and necessary workup including blood, fecal and urine tests to exclude differential diagnosis according to the Norwegian National Guidelines for Assessment of CFS/ME. Participants receive information about the study and give their written consent. Subjects earlier diagnosed with CFS/ME at FYSMED will undertake the same re-assessment.
During the work up, participants will do the Fatigue Severity Scale, Hospital Anxiety and Depression scale, SF 36, Modified DePaul Questionnaire, the Rome IV criteria for irritable bowel syndrome, and the "Repeatable Battery for the Assessment of Neuropsychological Status" test (RBANS). Heart rate variability is implemented as an additional measure when approximately 40 out of 80 participants are assigned treatment.
Donors are recruited informally from the local high schools. Donors are included and screened according to the European Consensus Guidelines from 2017. The full screening will be undertaken before the first feces donation and every 4th week. The inclusion and screening will be performed at the department of physical medicine and rehabilitation UNN Harstad. The investigators will keep a track record of screening failures noting reason for failure.
Participants receive FMT at the gastroenterology outpatient clinic at University Hospital of North Norway Harstad, Norway. No antibiotics are given prior to the intervention. The participants must do a bowel lavage using Sodiumpicosulphate/Magnesiumcitrate (Picoprep, Ferring) before intervention. The treatment will be administered by enema. Active treatment will be pre-processed frozen donor feces. Placebo will be the participant's own feces processed and frozen during the study inclusion. After the intervention, the participants have no restrictions on activity level and are asked to keep an unchanged diet without introduction of any new food supplements or probiotics in the follow up period. To keep track of change in diet investigators ask participants to do a food frequency questionnaire before the FMT and at 3 and 12 months after the intervention. Use of antibiotics, food supplement and use of medications will also be recorded.
The treatment will take place in blocks of four consecutive participants per day. A data engineer at the Department of Clinical Research at the University Hospital of North Norway, Tromsø (UNN,Tromsø) creates the allocation sequence using the REDCap software. The treatment is randomized on donor and placebo in fixed blocks of 4 with 2 active (1 donor A and 1 donor B) and 2 placebo. Block allocation will be stratified on gender.
A stratification on donor and gender will be performed by assigning full blocks of male and female participants. In the two active slots in each block of four, one active slot will be used for donor A and one for donor B. The stratification of gender reflects the higher incidence of CFS/ME in women. Donor fecal microbiota transplants stored for more than two years will be disposed and replaced with transplants from a new donor. If this happens, donor fecal microbiota transplants from the new donor will be assigned in remaining slots from the donor with the expired transplants.
Allocation is done in solitude in a closed room with no transparency, only containing a freezer with the active transplants (tagged by donor batch ID) and the placebo transplants (tagged by screening number). Before allocation of treatment, an investigator places the FMT-placebos on a table in the room. The allocator can then enter the room as the researcher placing all the placebos leaves the room. The allocator will access the randomization sequence when entering participants screening number on the REDCap software using a computer in the same room. The allocator will be the only person involved in the study that can access the randomization program at the REDCap software. If a screening number is randomized to active treatment, the allocator removes the tag from the placebo and places it on a donor FMT treatment instead. All unused placebo transplants will be disposed immediately. When finished, the allocator places the allocated treatment in a box in a designated freezer. The allocator will build a key file matching the active treatment to the donor batch id by updating a key file on paper and store it in a safe not accessible to any others. In addition the allocator will write the corresponding patient screeningnumber on tags from the used donor batch and keep them as backup in the same safe. This will allow for tracking of each individual donor batch to a corresponding participant at the end of trial when all follow up is complete.
FMT PARTICIPANTS
Inclusion Criteria:
Exclusion Criteria:
FMT DONORS
Inclusion criteria:
Exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The active transplants are processed in a 2-3 weeks period before treatment of the first participant. Fifty to eighty grams of freshly delivered feces from donors is mixed with 100 mL isotonic saline and 25 mL 85% glycerol, homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60 ml luerlock syringes and stored at -40°C. Frozen transplants are slowly thawed 2 hours prior to administration by transferring the FMT-syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in an enema bag prior to installation.
Biological: Preprocessed thawed donor FMT
The placebo transplant from each participant is prepared during the inclusion process four to six weeks before intervention and stored at -40°C. Fifty to eighty grams of freshly delivered feces from participants is mixed with 100 mL isotonic saline and 25 mL 85% glycerol is homogenized and poured through a 0.5 mm mesh steel strainer, and transferred to 60ml Luerlock syringes. Frozen transplants are slowly thawed 2 hours prior to administration by transferring the Luerlock syringes to a waterbath (+30°C). The transplant is then mixed with 125 mL 12°C isotonic saline in the enema bag prior to installation.
Biological: Preprocessed thawed autologous FMT
Delivered as an enema using the same equipment and technique as X-ray of the colon
Delivered as an enema using the same equipment and technique as X-ray of the colon
Proportion with treatment success in FSS score in donor versus placebo FMT group. Treatment success is defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS)
Fatigue Severity Scale (FSS) is a self-reported, 9-item fatigue scale. Participants rate all 9 items on a 7-point Likert scale (1-2-3-4-5-6-7) depending on how appropriate they felt the statement applied to them over the preceding week. The total score is calculated by adding up the answer from each item and divide by 9. Lower scores indicate better outcomes. Maximum score is 7. In an intention to treat analysis we will categorize participants as responders/non-responders, defining responders as decrease of more than 1,2 to the total baseline score in the FSS at 3 months post FMT by Chi Square. Baseline score will be the average of the two scores from the screening period. Missing values will be regarded as non responders
Time frame: Three months after treatment
Change in donor versus placebo FMT group in fatigue by the Fatigue Severity Scale score
Time frame: Change in Fatigue severity scale by repeated measures from baseline and until 1, 3, 6, 9 and 12 months after treatment
Change in donor versus placebo FMT group in quality of life by the SF36 score
The SF-36 consists of eight scaled scores (vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health), which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.
Time frame: Change in SF36 score by repeated measures from baseline and until 3 and 12 months after treamtent
Change in donor versus placebo FMT group in neurocognitive function by the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) score from baseline and until 3 months after treatment.
RBANS is a neuropsychological assessment that consists of ten subtests which give scores to five domains: Immediate memory, visuospatial/constructional ability, language, attention and delayed memory.
Time frame: Change from baseline and until three months after treatment
Change in donor versus placebo FMT group in anxiety and depression by the Hospital Anxiety Depression Scale (HADS) score
HADS is an instrument with 14-items for detection of depression and anxiety in hospitalized patients. Scores range from 1-21 interpreted as: normal (0-7), mild (8-10), moderate (11-14), severe (15-21). Subscales for anxiety (HADS-A) and depression (HADS-D) is also defined. We will explore the FMT effects on HADS by an independent sample T-test (or, if necessary, non-parametric Mann-Whitney) comparing change in global score. We will apply last value forward for missing values.
Time frame: Change in HADS score by repeated measures from baseline and until 3 and 12 months after treatment
Change in donor versus placebo FMT group in gastrointestinal related complaints by the sum score of selected items in the DePaul Questionnaire (DPQ) (29, 30, 46 and 47)
The DPQ assesses key symptoms of ME/CFS such as fatigue, gastrointestinal complaints, post-exertional malaise, sleep, pain, neurological/cognitive impairments and autonomic, neuroendocrine and immune symptoms. At each item, participants have to rate the frequency and severity of the symptom on a scale from 0 to 4. We wil use the sum score from the questions that assess gastrointestinal complaints in the DPQ in this endpoint. This endpoint was implemented after 19 out of 80 participants had completed the three months follow up
Time frame: Change in DPQ score by repeated measures from baseline and until 6 and 12 months after treatment
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Participants will be screened for adverse events from the time of informed consent through the end of the trial. In case of an identified adverse event, this will be recorded and described in the CRF
Time frame: Baseline to end of follow up at 12 months after FMT
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The primary vagal function outcome will be differences in changes from pre-post treatment between groups in High Frequency HRV (HF-HRV; in ms2
Firstbeat Bodyguard will record R-R interval and the Firstbeat life style assessment software will analyze the R-R interval recording and provide the outcome measure
Time frame: 3 months after treatment
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in the resting continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2)
Time frame: 3 months after treatment
Difference in mean baseline HRV (HF-HRV and RMSSD) between responders vs non-responders to donor FMT.
As defined by the primary endpoint in the clinical study, a responder will be defined as an improvement of more than 1.2 points on the Fatigue Severity Scale (FSS) from baseline and until 3 months after treatment. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.
Time frame: 3 months after treatment
Engraftment of donor microbiota
Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor mikrobiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
Time frame: 3 months after FMT
Engraftment of donor microbiota
Comparison between baseline profile, post FMT and donor profile will show if engraftment of donor microbiota parallels clinical response to active FMT. To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
Time frame: 12 months after FMT
Difference in metagenomic profile between responders and non responder to FMT
To assess fecal gut microbiota composition, morning stool samples will be obtained at baseline and three and twelve months after FMT. Participants will collect their first morning bowel movement in a 120ml container for storing in their home freezer (-20C). Two-four weeks after, samples will be collected from participants home and stored on dry ice during transport until freezing at -80°C at the University Hospital of North Norway Harstad. Fecal analysis will be done by NextSeq500 allowing for enhanced metagenomics (prokaryote and viral) sequencing.
Time frame: Baseline samples before FMT
Change in the nature of host immune and antibody response
Analysis (multipex technology) of mediators in the innate and adaptive immune response
Time frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months
Change in the nature of host immune and antibody response
Analysis (multipex technology) of mediators in the innate and adaptive immune response
Time frame: Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months
Difference in the nature of host immune and antibody response between responders and non responders to FMT
Analysis (multipex technology) of mediators in the innate and adaptive immune response
Time frame: Baseline samples before FMT
Change in the metabolome in feces, blood and urine
Analysis (mass spectrometry) on fecal extracts, urine and serum in order to assess the functional output of the microbiota
Time frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months
Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation
Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
Time frame: Change from baseline to 3 months and difference between responders and non-responders to treatment at 3 months
Change in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) before and after transplantation
Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
Time frame: Change from baseline to 12 months and difference between responders and non-responders to treatment at 12 months
Difference in biomarkers for breach in gut epithelium (sLPS-binding protein and sCD14) in responders and non responders to FMT
Analysis (ELISA) of immunological markers associated with gut barrier leak (sCD14 and sLPS-BP)
Time frame: Baseline samples before FMT
Plan to share: Yes — De-identified individual participant data for all primary and secondary outcome measures will be made available
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Available when findings from primary and secondary endpoints are published. Study protocol will be available upon request when we initiate the inclusion.
Access criteria: Data access requests will be reviewed by study investigators. Requestors will be required to sign a Data Access Agreement
No publications or documents are linked to this record.
Ran from Feb 2019 to primary completion in Mar 2023, 48 months.
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University Hospital of North Norway →