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| ID | Type | Description | Link |
|---|---|---|---|
| 3822-16-SMC | Other Identifier | Sheba Medical Center, Tel-HaShomer, Israel |
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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fecal Microbiota Transplantation (FMT) | Experimental | Participants will receive a single dose of oral FMT, which is 15 capsules per day for 2 consecutive days (total of 30 capsules). All capsules administered to a participant are from the same unrelated donor. Participants will be asked to fast for 4 hours prior to and 1 hour following capsule intake. Participants will be asked to drink at least 360cc of water during administration. Treatment will be administered on an inpatient basis. In patients with no/partial response, the FMT may be repeated from the same or a different donor. Subjects receiving any amount of the FMT capsules will be followed for at least 6 months.Stool and blood samples will be serially collected. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fecal Microbiota Transplantation | Biological | Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant. |
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| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Participants will be evaluated for serious adverse events (SAEs) relating to FMT occurring within 28 days following transplantation. SAEs are defined as any adverse experience occurring during or after FMT that results in any of the following outcomes: death, life-threatening experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity or an important medical event events | 28 days following FMT. |
| Measure | Description | Time Frame |
|---|---|---|
| Non-serious adverse events | Participants will be evaluated for non-serious adverse events relating to FMT within 28 days following transplantation. Non-serious adverse events are defined as diarrhea, nausea and vomiting, fatigue and malaise, headache, and distension/bloating/abdominal discomfort/pain | 28 days following FMT. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Roni Shouval, MD | Contact | 972-3-5305830 | roni.shoval@sheba.health.gov.il |
| Name | Affiliation | Role |
|---|---|---|
| Roni Shouval, MD | Sheba Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chaim Sheba Medical Center | Recruiting | Ramat Gan | Israel |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 18, 2021 | |
| Reset | Feb 5, 2021 |
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| Gut acute Graft-versus-Host Disease (aGvHD) response. |
Participants will be evaluated on days 7 and 28 following transplantation for response to therapy. Response criteria for steroid-resistant patients is as follows:
Response criteria for steroid-dependent patients is as follows:
|
| up to 28 days following FMT. |
| aGvHD severity | Participants will be evaluated on days 7 and 28 following transplantation for severity of aGvHD. aGVHD severity is graded by the International Bone Marrow Transplant Registry Severity Index grading system | up to 28 days following FMT. |
| Reduction in the dose of steroids. | The dose of methylprednisolone, or an equivalent GCS, will be evaluated on day 7, and 28. The change in the dose at day 28, adjusted to the type of GCS used. | up to 28 days following FMT. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 18, 2021 | Feb 5, 2021 |
| ID | Term |
|---|---|
| D006086 | Graft vs Host Disease |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D000069467 | Fecal Microbiota Transplantation |
| ID | Term |
|---|---|
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
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