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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06206707
Other study ID # 1-10-72-105-23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 23, 2024
Est. completion date March 31, 2025

Study information

Verified date December 2023
Source University of Aarhus
Contact Trine L Laursen, BSc
Phone +4540408207
Email trnlau@rm.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Description:

As above


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 31, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 years or above. 2. Histologically proven diagnosis of malignant melanoma and/or kidney cancer. 3. Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks. 4. Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7. 5. Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea. 6. Signed written informed consent. Exclusion Criteria: 1. Diagnosed bacterial infection requiring antibiotic treatment at inclusion. 2. Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test. 3. Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease. 4. Unable to ingest capsules. 5. Unable to understand written or oral patient information.

Study Design


Intervention

Procedure:
Faecal Microbiota Transplantation (FMT)
Capsule FMT
Placebo
Placebo capsules

Locations

Country Name City State
Denmark Aarhus University Hospital Aarhus N

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. At 42 days after intervention treatment
Secondary 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. At 42 days after intervention treatment
Secondary 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. At 42 days after intervention treatment
Secondary 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. Up to 12 weeks after intervention treatment
Secondary 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. Up to 12 weeks after intervention treatment
Secondary 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. Up to 12 weeks after intervention treatment
Secondary 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. At 42 days after intervention treatment
Secondary 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. At 12 weeks after intervention treatment
Secondary Faecal microbiota composition Changes in faecal microbiome composition from baseline to week 6 after the last intervention. Up to 6 weeks after intervention treatment
Secondary Gut mucosa-associated microbiome Changes in mucosa-associated microbiome from baseline to week 6 after the last intervention. Up to 6 weeks after intervention treatment
Secondary Faecal-calprotectin Percentual change in faecal-calprotectin from prior to intervention to week 6 after the last intervention. Up to 6 weeks after intervention treatment
Secondary Blood immunological parameters Changes in blood immunological parameters (including circulating cytokines) from baseline and at week 6 after the last intervention. Up to 6 weeks after intervention treatment
Secondary Hospitalisation Hospitalisation defined as the total number of days hospitalised, during 12 weeks of follow-up. Up to 12 weeks after intervention treatment
Secondary Colectomy Colectomy during 12 weeks of follow-up. Up to 12 weeks after intervention treatment
Secondary Mortality Mortality during the 12 weeks of follow-up. Up to 12 weeks after intervention treatment
Secondary Accumulated steroid dose Accumulated steroid dose (total dose in mg) during 12 weeks following experimental treatment. Up to 12 weeks after intervention treatment
Secondary Resumption of immune checkpoint inhibitor therapy Number of patients resuming immune checkpoint inhibitor therapy during the 12 weeks of follow-up. Up to 12 weeks after intervention treatment
Secondary 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). Up to 12 weeks after intervention treatment
Secondary 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. At 42 days after intervention treatment
Secondary Health-related quality of life Changes in health-related quality of life assessed by EQ-5D-5L at baseline and week 6. At 42 days after intervention treatment
Secondary Endoscopic response Endoscopic response, defined as decrease in Mayo endoscopic score =1 grade, at week 6 after the last intervention treatment. Up to 6 weeks after intervention treatment
Secondary Endoscopic remission Endoscopic remission, defined as Mayo endoscopic score 0, at week 6 after the last intervention treatment. Up to 6 weeks after intervention treatment
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