Irritable Bowel SyndromePhase 3NCT04691544
Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome
A Phase 3 study testing Fecal microbiota transplantation (FMT) in people with Irritable Bowel Syndrome, run by University Hospital of North Norway at 1 site in Norway.
Trial summary
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Irritable Bowel Syndrome
- What is being tested?
- Fecal microbiota transplantation (FMT)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteNorway
- Study dates
- 5 May 2021to 31 Dec 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with IBS in the primary or secondary health care service
- Aged 18-65 years with IBS defined by the Rome IV criteria:
- Moderate to severe IBS symptoms, as defined by a score of ≥175 on the IBS-SSS
- All participants >50 years: Colonoscopy within the last 5 years prior to study entry including negative mucosal biopsy for microscopic colitis in participants subtyped as IBS-D
Who cannot join
- Planned evaluations or examinations for bowel related complaints
- Known presence of:
- Endometriosis or polycystic ovarian syndrome
- Diabetes type 1 and 2
- Systemic disease including
- Morbidly obesity (BMI ≥35)
Show all 39Show fewer
- Severe autoimmune disease
- Severe immune deficiency (acquired, congenital or due to medication)
- Previous treatment with FMT
- History of:
- Severe psychiatric disorder, alcohol or drug abuse. Mood disorders are allowed as long as there is no reason to believe that it will interfere with the ability to participate in the study.
- Inflammatory bowel disease, microscopic colitis, diverticulitis or ileus
- Abdominal surgery, with the exception of appendectomy, cholecystectomy, caesarean section and hysterectomy
- Malignant disease (excluding basalioma)
- "Red flags'' indicating severe undiagnosed disease including:
- Night sweats (Repeated episodes of extreme perspiration that may soak nightclothes or bedding)
- Unintentional weight loss (≥ 4.5 kilograms, or 5% of normal body weight) over less than 12 months without knowing the reason
- Family history of GI cancer defined as two or more first- or second-degree relatives, with:
- ≥ 1 diagnosed by age 50, OR
- ≥ 3 first- or second-degree relatives with GI cancer diagnosis, independent of age
- Use of the following the previous 4 weeks:
- Drugs with effects on bowel function..Rescue medication, such as Polyethylene glycol (Laxabon, Movieprep, Movicol) or Loperamide is allowed
- Drugs with analgesic action. Use of paracetamol, Non.Steroid Anti-Inflammatory Drugs ≤3 days week is allowed.
- Use of proton pump inhibitors or other antacids ≥3 days week
- Introduction of antidepressants or anxiolytics the last 12 weeks. Patients on a stable dose >12 weeks are eligible.
- Treatment with antibiotics 12 weeks prior to study entry.
- Use of kolestyramin for bile acid malabsorption
- Pregnant, lactating or planning pregnancy.
- Physical exam indicating undiagnosed malignant, autoimmune, or infectious disease
- Laboratory work up indicating undiagnosed digestive, malignant, autoimmune, infectious disease or alternative diagnosis to the IBS related signs and symptoms. The work up includes:
- Full blood count
- Erythrocyte sedimentation rate (ESR)
- C-reactive protein
- Anti-tissue transglutaminase IgA, total IgA
- Lactase genotype
- Stool tests for:
- Occult blood (Hemofec©).
- Fecal calprotectin indicating inflammatory bowel disease. The detection limit that excludes participants will depend on which assays is used for analysis at the different study centers.
- Only if indicated by the patient history (i.e. travelers diarrhea): Stool test for fecal ova and parasite, Clostridoides difficile toxin and pathogenic bacteria (Shigella spp, Salmonella spp. Campylobacter spp, Yersinia spp, and toxin-producing Clostridoides difficile.) All test results must be negative.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome: a Double Blind, Placebo-Controlled, Randomized Trial
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation (FMT) (Number needed to treat only five) (Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomized, placebo-controlled, parallel-group, single-centre trial he Lancet Gastroenterology and Hepatology 2018). Additional results from the same trial show that the treatment response may be predicted (unpublished data), and that the pathophysiologic mechanisms behind the treatment response also can be identified (Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome, Gut Microbes 2020). This study is the first phase 3 trial of FMT for IBS worldwide.
The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS, with little adverse events or complications. Patients ≥18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized, placebo controlled, parallell-group multi center trial. Participants are randomized to FMT from a healthy donor (intervention group), or their own feces (placebo group). The primary outcome is the proportion of patients with ≥75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment.
- Conditions
- Irritable Bowel Syndrome
- Being tested
- Fecal microbiota transplantation (FMT)
- Keywords
- fecal microbiota therapy, bacteriotherapy, stool transplant, IBS, FMT, gut microbiota brain axis, functional disorder, IBS-M, IBS-D, IBS-C
- Medical subject headings
- Irritable Bowel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation (FMT)Biological
Delivered by enema
| Study group | Role | What they receive |
|---|---|---|
| Fecal microbiota transplant from donor A | Active comparator | One FMT delivered by enema Receives: Biological: Fecal microbiota transplantation (FMT) |
| Fecal microbiota transplant from donor B | Active comparator | One FMT delivered by enema Receives: Biological: Fecal microbiota transplantation (FMT) |
| Fecal microbiota transplant from donor C | Active comparator | One FMT delivered by enema Receives: Biological: Fecal microbiota transplantation (FMT) |
| Fecal microbiota transplant from autologous feces | Placebo comparator | One FMT delivered by enema Receives: Biological: Fecal microbiota transplantation (FMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion in the donorFMT (dFMT) versus autologousFMT (aFMT) group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 90 after treatment when compared to the score 8 days before treatment
Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. The IBS-SSS has five items. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.
Measured: Day 90 after treatment
Secondary outcomes (15)
Proportion in dFMT versus aFMT group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 365 after treatment when compared to the score 8 days before treatment
Measured: Day 365 after treatment
Proportion of patients in dFMT versus aFMT group with a ≥14 points increase in the IBS-Qualiy of Life (IBS-QoL) day 90 after treatment when compared to the score 8 days before treatment
The IBS-QoL is a validated self-report questionnaire specific to IBS to evaluate quality of life over the past 30 days. It consists of 34 items, each with a five-point Likert scale. The individual response to the 34 items are summed and averaged for a total score and then transformed to a 0-100 scale for ease of interpretation with higher scores indicating better IBS specific quality of life. The cut-off for meaningful clinical improvement is set at ≥14 points. There are also eight subscale scores for the IBS-QOL (Dysphoria, Interference with Activity, Body Image, Health Worry, Food Avoidance, Social Reaction, Sexual, Relationships)
Measured: Day 90 after treatment
Proportion in the dFMT vs aFMT group with 2 or more weeks with treatment success in Adequate relief by the Global Improvement Scale and Abdominal pain day 69, 76, 83 and 90 after treatment. For treatment success criteria A. and B. have to be fulfilled
- A. Adequate relief is determined by the patient question "How would you rate your IBS signs and symptoms overall over the past 7 days?". Criteria A. is fulfilled when participants score 1 or 2 on a 7-point numerical rating scale.
- B. Abdominal pain is determined by the question "How would you rate your abdominal pain overall over the past 7 days?" The patient answer on a 11-point numerical rating scale, where 0 is "No pain" and 10 is "Worst possible pain''. Criteria B. is fulfilled when participants experience a 30% decrease in the scale score after treatment, compared to the score before treatment.
Measured: Day 69, 76, 83 and 90 after treatment
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Measured: Day 90 after treatment
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Measured: Day 365 after treatment
Change in the dFMT vs aFMT group in mean stool consistency score in the period 8-2 days before treatment, compared to mean stool consistency score in the period 84-90 and 359-365 days after treatment.
This endpoint only apply to participants subtyped with IBS-diarrhea before treatment.
Mean stool consistency score is measured by Bristol Stool Scale ("How would you rate the stool consistency overall the last 24 hours?").
Mean stool consistency score will be derived from: (Sum of each rating by the Bristol Stool Form Scale in a period )/(Number of ratings in a period).
Measured: 2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Change in the dFMT vs aFMT group in mean number of complete spontaneous bowel movements (CSBM) in the period 8-2 days before treatment, compared to CSBM in the period 84-90 and 359-365 days after treatment
This endpoint only apply to participants subtyped with with IBS-constipation before treatment.
CSBM is measured by the question. "How many CSBM have you passed the last 24 hours?" reported by the participant every second day for eight days?''
Mean number of complete spontaneous bowel movements will be derived from: (Sum of number of CSBM in each period)/number of assessments of CSBM in a period)
Measured: 2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Change in the dFMT vs aFMT group in bowel-related complaints by the item specific and global Irritable Bowel Syndrome Symptom Severity Score score from before and until after treatment.
Measured: 8 days before treatment and until 30, 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in quality of life by the global and subdomain specific score in the Irritable Bowel Syndrome-Qualiy of Life from before and until after treatment.
Measured: 8 days before treatment and until 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in fatigue by the global and subdomain specific score in the Modified Fatigue Impact Scale from before and until after treatment.
Items on the MFIS can be aggregated into three subscales (physical (range 0 to 36), cognitive (range 0 to 40), and psychosocial (range 0 to 8)), as well as into a total MFIS score (range 0 to 84). All items are scaled so that higher scores indicate a greater impact of fatigue on a person's activities.
Measured: 8 days before treatment and until 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in anxiety and depression (HADS) by the global and subdomain specific score on the Hospital Anxiety and Depression Scale from before and until after treatment.
The HADS is a fourteen item scale where seven of the items relate to anxiety and seven to depression. Each item on the questionnaire is scored from 0-3 and this means that a person can score between 0 and 21 for either anxiety or depression. Higher scores indicates higher levels of anxiety or depression
Measured: 8 days before treatment and until 90, 180 and 365 days after treatment
Proportion of participants identified as treatment success (as defined by the primary endpoint) by a ten species profile generated from a metagenomic dataset from the pilot REFIT trial (unpublished data)
Measured: Day 90
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
Measured: 90 days after treatment
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in continuous ECG recordings. The secondary vagal function outcome will be differences in changes from pre-post treatment between groups in RMSSD (RMSSD; in ms2).
Measured: 90 days 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 phase III study, a responder will be defined by a decrease of 75 points from baseline in the irritable bowel symptom severity score 90 days after the intervention with FMT. To determine HRV in each group we will use High Frequency Power analysis denominating HRV in ms2.
Measured: 90 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start5 May 2021
- Primary completion1 Sep 2023
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Triple blind randomized, placebo controlled, parallell-group multi center trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Collaborators
- Oslo University Hospital, Sorlandet Hospital HF, Haukeland University Hospital, Alesund Hospital
- Responsible party
- Sponsor
- Investigators
- Peter H Johnsen, MD PhD, Principal investigator, Univeristy Hospital of North NorwayRasmus Goll, MD PhD, Principal investigator, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691544
- Sponsor's protocol ID
- 183984
- Status last verified
- Feb 2024
- First submitted
- 15 Dec 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Johnsen PH, Juul FE, Hoff DAL, Hillestad ER, Holme O, Skjevling LK, Hansen HM, Rasmus MH, Barnett L, Barry SJE, Hjerde E, Lindstedt K, Buczek DJ, Hatlebakk JG, Steinsvik EK, Berentsen B, Garborg KK, Valeur J, Valle PC, Loberg M, Kalager M, Bretthauer M, Goll R. Faecal microbiota transplantation in irritable bowel syndrome (REFIT2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026 Sep 24:S0140-6736(26)01424-8. doi: 10.1016/S0140-6736(26)01424-8. Online ahead of print.
PubMed 42785338
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Donor Versus Autologous Fecal Microbiota Transplantation for Irritable Bowel Syndrome: a Double Blind, Placebo-Controlled, Randomized Trial
- ClinicalTrials.gov ID
- NCT04691544
- Acronym / sponsor ID
- 183984
- Conditions
- Irritable Bowel Syndrome
- Keywords
- fecal microbiota therapy, bacteriotherapy, stool transplant, IBS, FMT, gut microbiota brain axis, functional disorder, IBS-M
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Collaborators
- Oslo University Hospital, Sorlandet Hospital HF, Haukeland University Hospital, Alesund Hospital
- Study start
- 5 May 2021 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Many patients with irritable bowel syndrome (IBS) do not experience adequate symptom relief with current treatments. The pathophysiology of IBS is diverse, controversial and not completely understood. The next disruptive frontier would be to find a cure where the effect is predictable and lasting. The study groups phase 2 pilot trial was the first indication of a possible benefit from treating IBS with fecal microbiota transplantation (FMT) (Number needed to treat only five) (Fecal microbiota transplantation versus placebo for moderate-to-severe irritable bowel syndrome: a double-blind, randomized, placebo-controlled, parallel-group, single-centre trial he Lancet Gastroenterology and Hepatology 2018). Additional results from the same trial show that the treatment response may be predicted (unpublished data), and that the pathophysiologic mechanisms behind the treatment response also can be identified (Effects of fecal microbiota transplantation in subjects with irritable bowel syndrome are mirrored by changes in gut microbiome, Gut Microbes 2020). This study is the first phase 3 trial of FMT for IBS worldwide.
The hypothesis of the trial is that donor FMT is more effective than placebo FMT in treating IBS, with little adverse events or complications. Patients ≥18 years with IBS are enrolled at five Norwegian Hospitals in this double blind randomized, placebo controlled, parallell-group multi center trial. Participants are randomized to FMT from a healthy donor (intervention group), or their own feces (placebo group). The primary outcome is the proportion of patients with ≥75 points decrease in the Irritable bowel Symptom Severity score 90 days after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
- Model description
- Triple blind randomized, placebo controlled, parallell-group multi center trial
| Arm | Type | Receives |
|---|---|---|
| Fecal microbiota transplant from donor A | Active comparator | Biological: Fecal microbiota transplantation (FMT)One FMT delivered by enema |
| Fecal microbiota transplant from donor B | Active comparator | Biological: Fecal microbiota transplantation (FMT)One FMT delivered by enema |
| Fecal microbiota transplant from donor C | Active comparator | Biological: Fecal microbiota transplantation (FMT)One FMT delivered by enema |
| Fecal microbiota transplant from autologous feces | Placebo comparator | Biological: Fecal microbiota transplantation (FMT)One FMT delivered by enema |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosed with IBS in the primary or secondary health care service
- Aged 18-65 years with IBS defined by the Rome IV criteria:
- Moderate to severe IBS symptoms, as defined by a score of ≥175 on the IBS-SSS
- All participants >50 years: Colonoscopy within the last 5 years prior to study entry including negative mucosal biopsy for microscopic colitis in participants subtyped as IBS-D
Key exclusion criteria (39 listed)
- Planned evaluations or examinations for bowel related complaints
- Known presence of:
- Morbidly obesity (BMI ≥35)
- Severe autoimmune disease
- Severe immune deficiency (acquired, congenital or due to medication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal microbiota transplantation (FMT)Delivered by enema | Biological | Fecal microbiota transplant from autologous feces, Fecal microbiota transplant from donor A, Fecal microbiota transplant from donor B, Fecal microbiota transplant from donor C |
Primary outcome
Proportion in the donorFMT (dFMT) versus autologousFMT (aFMT) group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 90 after treatment when compared to the score 8 days before treatment
Time frame: Day 90 after treatment
Scores on the IBS-SSS can range from 0 to 500 with higher scores indicating more severe symptoms. The IBS-SSS has five items. Subjects can be categorized as having mild (75-175), moderate (175-300), or severe (>300) IBS. A decrease of 50 points is associated with a clinically meaningful improvement.
15 secondary outcomes
Proportion in dFMT versus aFMT group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 365 after treatment when compared to the score 8 days before treatment
Time frame: Day 365 after treatment
Proportion of patients in dFMT versus aFMT group with a ≥14 points increase in the IBS-Qualiy of Life (IBS-QoL) day 90 after treatment when compared to the score 8 days before treatment
Time frame: Day 90 after treatment
Proportion in the dFMT vs aFMT group with 2 or more weeks with treatment success in Adequate relief by the Global Improvement Scale and Abdominal pain day 69, 76, 83 and 90 after treatment. For treatment success criteria A. and B. have to be fulfilled
Time frame: Day 69, 76, 83 and 90 after treatment
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Time frame: Day 90 after treatment
Proportion of adverse events and serious adverse events in the dFMT versus aFMT group from treatment and until day 90 after treatment
Time frame: Day 365 after treatment
Change in the dFMT vs aFMT group in mean stool consistency score in the period 8-2 days before treatment, compared to mean stool consistency score in the period 84-90 and 359-365 days after treatment.
Time frame: 2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Change in the dFMT vs aFMT group in mean number of complete spontaneous bowel movements (CSBM) in the period 8-2 days before treatment, compared to CSBM in the period 84-90 and 359-365 days after treatment
Time frame: 2-8 days before treatment and day 84 to 90 and day 259 to 365 after treatment
Change in the dFMT vs aFMT group in bowel-related complaints by the item specific and global Irritable Bowel Syndrome Symptom Severity Score score from before and until after treatment.
Time frame: 8 days before treatment and until 30, 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in quality of life by the global and subdomain specific score in the Irritable Bowel Syndrome-Qualiy of Life from before and until after treatment.
Time frame: 8 days before treatment and until 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in fatigue by the global and subdomain specific score in the Modified Fatigue Impact Scale from before and until after treatment.
Time frame: 8 days before treatment and until 90, 180 and 365 days after treatment
Change in the dFMT vs aFMT group in anxiety and depression (HADS) by the global and subdomain specific score on the Hospital Anxiety and Depression Scale from before and until after treatment.
Time frame: 8 days before treatment and until 90, 180 and 365 days after treatment
Proportion of participants identified as treatment success (as defined by the primary endpoint) by a ten species profile generated from a metagenomic dataset from the pilot REFIT trial (unpublished data)
Time frame: Day 90
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).
Time frame: 90 days after treatment
Change in HRV in donor FMT vs placebo FMT group derived from the R-R intervals in 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: 90 days after treatment
Difference in mean baseline HRV (HF-HRV and RMSSD) between responders' vs non-responders to donor FMT.
Time frame: 90 days after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Derived from this study: PubMed 42785338Johnsen PH, Juul FE, Hoff DAL, Hillestad ER, Holme O, Skjevling LK, Hansen HM, Rasmus MH, Barnett L, Barry SJE, Hjerde E, Lindstedt K, Buczek DJ, Hatlebakk JG, Steinsvik EK, Berentsen B, Garborg KK, Valeur J, Valle PC, Loberg M, Kalager M, Bretthauer M, Goll R. Faecal microbiota transplantation in irritable bowel syndrome (REFIT2): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2026 Sep 24:S0140-6736(26)01424-8. doi: 10.1016/S0140-6736(26)01424-8. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter H Johnsen, MD PhD principal investigator
Univeristy Hospital of North Norway
Rasmus Goll, MD PhD principal investigator
University Hospital of North Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fecal microbiota transplantation (FMT) in people with Irritable Bowel Syndrome, run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 39 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion in the donorFMT (dFMT) versus autologousFMT (aFMT) group with ≥75 points decrease in the Irritable Bowel Syndrome Symptom Severity Scale (IBS-SSS) day 90 after treatment when compared to the score 8 days before treatment (time frame: Day 90 after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04691544, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.