DiarrheaImmunobiomeNCT06206707
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
A study testing Faecal Microbiota Transplantation (FMT) in people with Diarrhea and Colitis, run by University of Aarhus at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diarrhea, Colitis, Malignant Melanoma
- What is being tested?
- Faecal Microbiota Transplantation (FMT)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteDenmark
- Study dates
- 23 Jan 2024to 31 Oct 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or above.
- Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
- Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
- Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
- Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
- Signed written informed consent.
Who cannot join
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
- Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
- Unable to ingest capsules.
- Unable to understand written or oral patient information.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aarhus University Hospital
Aarhus N, 8200
Christian L Hvas, PhD, +45 28351839, christian.hvas@auh.rm.dk
Trine L Laursen, BSc, trnlau@rm.dk
About this study
Official title: Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.
The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.
Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.
Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.
Read the detailed description
As above
- Conditions
- Diarrhea, Colitis, Malignant Melanoma, Kidney Cancer
- Being tested
- Faecal Microbiota Transplantation (FMT), Placebo
- Medical subject headings
- Diarrhea, Colitis, Melanoma, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Faecal Microbiota Transplantation (FMT)Procedure or surgery
Also called Fecal Microbiota Transplantation, FMT
Capsule FMT
PlaceboProcedure or surgery
Placebo capsules
| Study group | Role | What they receive |
|---|---|---|
| Faecal microbiota transplantation (FMT) | Experimental | Patients receive two applications of capsule FMT with 3-7 days between applications. Receives: Procedure: Faecal Microbiota Transplantation (FMT) |
| Placebo | Placebo comparator | Patients receive two applications of placebo capsules with 3-7 days between applications. Receives: Procedure: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical remission of immune-mediated diarrhea
Number of patients with steroid-free resolution of diarrhea, defined as < 3 liquid stools (Bristol <6) per 24 hours during day 40 and 41 after the last intervention treatment.
Measured: At 42 days after intervention treatment
Secondary outcomes (21)
Remission of diarrhea defined by CTCAE
Number of patients in steroid-free clinical remission of diarrhea 6 weeks (42 days) after the last intervention treatment. Clinical remission is defined as < 4 stools over baseline per day (CTCAE diarrhea grade 1 or less), at day 40 and 41.
Measured: At 42 days after intervention treatment
Remission of colitis defined by CTCAE
Number of patients in steroid-free clinical remission of colitis 6 weeks (42 days) after the last intervention treatment. Clinical remission is defined as asymptomatic in regards to colitis (CTCAE colitis grade 1 or less), at day 40 and 41.
Measured: At 42 days after intervention treatment
Therapy response of FMT
Therapy response defined as a decrease of at least 3 points in Simple Clinical Colitis Activity Index (SCCAI) score, at weeks 1, 6 and 12 after the last intervention treatment.
Measured: Up to 12 weeks after intervention treatment
Number of days until CTCAE diarrhea grade 1
Number of days until less than 4 stools over baseline per day (CTCAE diarrhea grade 1 or less), lasting a minimum of 48 consecutive hours with no increase in steroid dose in the 12 weeks of follow-up.
Measured: Up to 12 weeks after intervention treatment
Number of days until resolution of diarrhea
Number of days until resolution of diarrhea, defined as 3 or fewer Bristol type 6-7 stools per day, lasting a minimum of 48 consecutive hours.
Measured: Up to 12 weeks after intervention treatment
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Number of adverse events (AE) during first 6 weeks after intervention treatment. AE's will be graded by CTCAE.
Measured: At 42 days after intervention treatment
Incidence of fecal microbiota transplantation (FMT)-related serious adverse events
Number of serious adverse events (SAE) during 12 weeks follow-up after the final intervention treatment. SAE's will be graded by CTCAE.
Measured: At 12 weeks after intervention treatment
Faecal microbiota composition
Changes in faecal microbiome composition from baseline to week 6 after the last intervention.
Measured: Up to 6 weeks after intervention treatment
Gut mucosa-associated microbiome
Changes in mucosa-associated microbiome from baseline to week 6 after the last intervention.
Measured: Up to 6 weeks after intervention treatment
Faecal-calprotectin
Percentual change in faecal-calprotectin from prior to intervention to week 6 after the last intervention.
Measured: Up to 6 weeks after intervention treatment
Blood immunological parameters
Changes in blood immunological parameters (including circulating cytokines) from baseline and at week 6 after the last intervention.
Measured: Up to 6 weeks after intervention treatment
Hospitalisation
Hospitalisation defined as the total number of days hospitalised, during 12 weeks of follow-up.
Measured: Up to 12 weeks after intervention treatment
Colectomy
Colectomy during 12 weeks of follow-up.
Measured: Up to 12 weeks after intervention treatment
Mortality
Mortality during the 12 weeks of follow-up.
Measured: Up to 12 weeks after intervention treatment
Accumulated steroid dose
Accumulated steroid dose (total dose in mg) during 12 weeks following experimental treatment.
Measured: Up to 12 weeks after intervention treatment
Resumption of immune checkpoint inhibitor therapy
Number of patients resuming immune checkpoint inhibitor therapy during the 12 weeks of follow-up.
Measured: Up to 12 weeks after intervention treatment
Response to immune checkpoint inhibitor therapy
Response to immune checkpoint inhibitor therapy defined by Response Evaluation Criteria in Solid Tumours (RECIST 1.1 and iRECIST).
Measured: Up to 12 weeks after intervention treatment
Patient and physician perceptions of FMT treatment
Patient and physician perceptions of FMT treatment and the usage for IMC assessed by a patient questionnaire at week 6 and a physician questionnaire.
Measured: At 42 days after intervention treatment
Health-related quality of life
Changes in health-related quality of life assessed by EQ-5D-5L at baseline and week 6.
Measured: At 42 days after intervention treatment
Endoscopic response
Endoscopic response, defined as decrease in Mayo endoscopic score ≥1 grade, at week 6 after the last intervention treatment.
Measured: Up to 6 weeks after intervention treatment
Endoscopic remission
Endoscopic remission, defined as Mayo endoscopic score 0, at week 6 after the last intervention treatment.
Measured: Up to 6 weeks after intervention treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start23 Jan 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a double-blind, placebo controlled, randomised trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christian L Hvas, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06206707
- Sponsor's protocol ID
- 1-10-72-105-23
- Acronym
- Immunobiome
- Status last verified
- Nov 2025
- First submitted
- 2 Jan 2024
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Open access publication, raw data available upon reasonable request and according to data protection regulation.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
- ClinicalTrials.gov ID
- NCT06206707
- Acronym / sponsor ID
- Immunobiome / 1-10-72-105-23
- Conditions
- Diarrhea, Colitis, Malignant Melanoma, Kidney Cancer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 16 Jan 2024 (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.
The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial.
The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC.
Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC.
Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.
Detailed description
As above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a double-blind, placebo controlled, randomised trial
| Arm | Type | Receives |
|---|---|---|
| Faecal microbiota transplantation (FMT) | Experimental | Procedure: Faecal Microbiota Transplantation (FMT)Patients receive two applications of capsule FMT with 3-7 days between applications. |
| Placebo | Placebo comparator | Procedure: PlaceboPatients receive two applications of placebo capsules with 3-7 days between applications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or above.
- Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
- Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
- Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.
- Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea.
Key exclusion criteria (5 listed)
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test.
- Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease.
- Unable to ingest capsules.
- Unable to understand written or oral patient information.
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 |
|---|---|---|
| Faecal Microbiota Transplantation (FMT)Also: Fecal Microbiota Transplantation, FMTCapsule FMT | Procedure or surgery | Faecal microbiota transplantation (FMT) |
| PlaceboPlacebo capsules | Procedure or surgery | Placebo |
Primary outcome
Clinical remission of immune-mediated diarrhea
Time frame: At 42 days after intervention treatment
Number of patients with steroid-free resolution of diarrhea, defined as < 3 liquid stools (Bristol <6) per 24 hours during day 40 and 41 after the last intervention treatment.
21 secondary outcomes
Remission of diarrhea defined by CTCAE
Time frame: At 42 days after intervention treatment
Remission of colitis defined by CTCAE
Time frame: At 42 days after intervention treatment
Therapy response of FMT
Time frame: Up to 12 weeks after intervention treatment
Number of days until CTCAE diarrhea grade 1
Time frame: Up to 12 weeks after intervention treatment
Number of days until resolution of diarrhea
Time frame: Up to 12 weeks after intervention treatment
Incidence of fecal microbiota transplantation (FMT)-related adverse events
Time frame: At 42 days after intervention treatment
Incidence of fecal microbiota transplantation (FMT)-related serious adverse events
Time frame: At 12 weeks after intervention treatment
Faecal microbiota composition
Time frame: Up to 6 weeks after intervention treatment
Gut mucosa-associated microbiome
Time frame: Up to 6 weeks after intervention treatment
Faecal-calprotectin
Time frame: Up to 6 weeks after intervention treatment
Blood immunological parameters
Time frame: Up to 6 weeks after intervention treatment
Hospitalisation
Time frame: Up to 12 weeks after intervention treatment
Colectomy
Time frame: Up to 12 weeks after intervention treatment
Mortality
Time frame: Up to 12 weeks after intervention treatment
Accumulated steroid dose
Time frame: Up to 12 weeks after intervention treatment
Resumption of immune checkpoint inhibitor therapy
Time frame: Up to 12 weeks after intervention treatment
Response to immune checkpoint inhibitor therapy
Time frame: Up to 12 weeks after intervention treatment
Patient and physician perceptions of FMT treatment
Time frame: At 42 days after intervention treatment
Health-related quality of life
Time frame: At 42 days after intervention treatment
Endoscopic response
Time frame: Up to 6 weeks after intervention treatment
Endoscopic remission
Time frame: Up to 6 weeks after intervention 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 17 Nov 2025.
- Centre for faecal microbiota transplantation (CEFTA)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Open access publication, raw data available upon reasonable request and according to data protection regulation.
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
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.
Christian L Hvas, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Faecal Microbiota Transplantation (FMT) in people with Diarrhea and Colitis, run by University of Aarhus at 1 site in Denmark.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Nov 2025. 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 Denmark. 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.
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?
Contact Trine L Laursen, BSc (+4540408207, trnlau@rm.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical remission of immune-mediated diarrhea (time frame: At 42 days after intervention treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Nov 2025.