An interventional study of Faecal Microbiota Transplantation (FMT) and Placebo in Diarrhea, Colitis and Malignant Melanoma, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-11-17.
Sponsored by University of Aarhus · Not applicable, Interventional, and Treatment
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.
As above
877 studies on the registry are indexed under Diarrhea; 76 are open to participants now.
This study's planned enrollment of 20 is below the median of 137 across 738 interventional studies indexed under Diarrhea.
Browse Diarrhea studies →University of Aarhus is the lead sponsor of 1,300 studies on the registry; 189 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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 diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
PD-1, PD-L1 and checkpoint inhibitors
PD-1, PD-L1 and CTLA-4 are proteins that act as brakes on the immune system. Checkpoint inhibitors, such as pembrolizumab or nivolumab, block them so the immune system can attack a cancer.
PD-L1 can also be measured in a tumour sample. Some scores count stained tumour cells only (TPS); others also count certain immune cells (CPS). The study names the score and the minimum it uses.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CTCAE grade
The US National Cancer Institute’s scale of how severe an adverse event is — any unwanted medical event during a study, such as a symptom, an illness or an abnormal test result, whether or not a treatment caused it. Whether it did is judged separately.
“Side effects of earlier treatment resolved to grade 1 or less” means they have settled to mild or gone.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients receive two applications of capsule FMT with 3-7 days between applications.
Procedure: Faecal Microbiota Transplantation (FMT)
Patients receive two applications of placebo capsules with 3-7 days between applications.
Procedure: Placebo
Capsule FMT
Also known as: Fecal Microbiota Transplantation, FMT
Placebo capsules
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.
Time frame: At 42 days after intervention treatment
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: At 12 weeks after intervention treatment
Faecal microbiota composition
Changes in faecal microbiome composition from baseline to week 6 after the last intervention.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 weeks after intervention treatment
Hospitalisation
Hospitalisation defined as the total number of days hospitalised, during 12 weeks of follow-up.
Time frame: Up to 12 weeks after intervention treatment
Colectomy
Colectomy during 12 weeks of follow-up.
Time frame: Up to 12 weeks after intervention treatment
Mortality
Mortality during the 12 weeks of follow-up.
Time frame: Up to 12 weeks after intervention treatment
Accumulated steroid dose
Accumulated steroid dose (total dose in mg) during 12 weeks following experimental treatment.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 6 weeks after intervention treatment
Plan to share: Yes — Open access publication, raw data available upon reasonable request and according to data protection regulation.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: Protocol: On request. Other: after study completion
Access criteria: Evaluated after email request, trnlau@rm.dk
Started Jan 2024 (actual). Primary completion is estimated for Jun 2026, 29 months after the start.
Of 129 non-industry interventional studies with no phase under Diarrhea, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 36. This study's planned 29 months is above that.
Counting every sponsor, half of 164 studies reached it within 14 months; a quarter within 5 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
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