Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease Clinical Trial
Official title:
Investigator-initiated Trial to Explore the Efficacy and Safety of Fecal Microbiota Transplant (FMT) Capsule in the Treatment of Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease Patients
| NCT number | NCT04622475 |
| Other study ID # | XBI-302CT1004 |
| Secondary ID | |
| Status | Recruiting |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | November 2020 |
| Est. completion date | June 2022 |
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD. Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection. The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD. This study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.
| Status | Recruiting |
| Enrollment | 10 |
| Est. completion date | June 2022 |
| Est. primary completion date | August 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility | Inclusion Criteria: 1. Patients must be willing and able to sign the informed consent form and complete the follow-up visits. 2. 18-75 years old. No gender limitation. 3. Patients who can swallow the capsules without chewing. 4. Patients who were clinically diagnosed as steroid refractory GI-aGvHD. The diagnosis criteria are: experiencing GI-aGvHD clinical manifestations (e.g., abdominal cramps, diarrhea, stool blood) within 100 days after receiving hematopoietic stem cell transplant (HSCT); having Grade 2-4 gastrointestinal clinical symptoms; excluding diarrhea caused solely by pathogen infection; after adequate steroid treatment, disease progression on day 3, or with no change on day 7, or without complete response on day 14. 5. Patients who had complicated infection after the diagnosis of aGvHD, but are able to discontinue all the antibiotic therapy 12 hours before receiving FMT treatment. 6. ECOG scale =3 7. Basic body function indexes reach the following criteria: total neutrophil=0.5*10^9/L, platelet count=100*10^9/L, serum creatinine =1.5×upper limit of normal (ULN) or creatinine clearance=40 mL/min, albumin=25g/L. Exclusion Criteria: 1. Patients with extremely serious grade IV aGvHD (life-threatening or with serious non-GvHD complication). 2. Refractory malignant condition. 3. Patients who have received two or more HSCT. 4. Patients who have active infection that has not been controlled and must receive antibiotic therapy, including diarrhea (non-GvHD diarrhea) caused by infection or antibiotics, excluding GvHD complicated infective diarrhea. 5. Patients who have gastrointestinal perforation or toxic intestinal. 6. Patients who have a history of severe allergic reactions. 7. Any condition in which PI do not consider it appropriate to participate (e.g., any medical history, treatment history, or abnormal history of testing data that may confuse the study results, or interfere with the patient's full participation in the study, or hurt the patient's benefit) 8. Female patients who have positive pregnancy test results or are breastfeeding. Women of childbearing age who refuse to use contraception one month after FMT treatment. |
| Country | Name | City | State |
|---|---|---|---|
| China | Nanfang Hospital, Southern Medical University | Guangzhou | Guangdong |
| Lead Sponsor | Collaborator |
|---|---|
| Nanfang Hospital of Southern Medical University |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The number of adverse events (AEs)/serious adverse events (SAEs) | The number of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT). | 28 days | |
| Primary | The severity of AEs/SAEs | The severity of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT). | 28 days | |
| Secondary | Response rate | GI-aGvHD response rate (Complete response+Partial response) on Day 28 after the first dose of FMT (Day 1 is the last day of the first dose of FMT). | 28 days | |
| Secondary | Changes in gut microbiota | Compare the gut microbiota diversity and major bacterial genus before and 28, 43(for subjects recieved 2 dose of FMT), 84 and 168 days after FMT treatment. | Days 28, 43, 84, and 168 | |
| Secondary | The number of AEs/SAEs | The number of FMT capsule associated AEs/SAEs occurring from the first FMT treatment to Weeks 12 and 24 after the first FMT treatment. | Weeks 12 and 24 | |
| Secondary | The severity of AEs/SAEs | The severity of FMT capsule associated AEs/SAEs occurring from the first FMT treatment to Weeks 12 and 24 after the first FMT treatment. | Weeks 12 and 24 |