Fecal Microbiota Transplantation for Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease
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|ClinicalTrials.gov Identifier: NCT03214289|
Recruitment Status : Unknown
Verified April 2018 by Dr. Shouval Roni, Sheba Medical Center.
Recruitment status was: Recruiting
First Posted : July 11, 2017
Last Update Posted : April 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplant Complications Graft Versus Host Disease, Acute Fecal Microbiota Transplantation||Biological: Fecal Microbiota Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for Treatment of Steroid Resistant and Steroid Dependent Gut Acute Graft Versus Host Disease- a Pilot Study|
|Actual Study Start Date :||July 12, 2017|
|Estimated Primary Completion Date :||July 20, 2019|
|Estimated Study Completion Date :||December 20, 2019|
Experimental: Fecal Microbiota Transplantation (FMT)
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.
Biological: Fecal Microbiota Transplantation
Thirty fecal microbiota capsules produced from a single healthy donor, unrelated to the participant.
- Serious adverse events [ Time Frame: 28 days following FMT. ]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
- Non-serious adverse events [ Time Frame: 28 days following FMT. ]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
- Gut acute Graft-versus-Host Disease (aGvHD) response. [ Time Frame: up to 28 days following FMT. ]
Participants will be evaluated on days 7 and 28 following transplantation for response to therapy.
Response criteria for steroid-resistant patients is as follows:
- Complete response: resolution of all gastrointestinal signs and symptoms
- Partial response: decrease in severity of gut GVHD by at least one stage
- Progression: Progressive worsening of gut GVHD
- No change: No significant change in gut GVHD
Response criteria for steroid-dependent patients is as follows:
- Complete response: reduction of the steroid dose to 5 mg or less of prednisone (or a steroid equivalent) per day.
- Partial response: a reduction of ≥40% in the dose of steroid
- Progression: an increase of >=10% in the steroid dose
- No change: any other option
- aGvHD severity [ Time Frame: up to 28 days following FMT. ]
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
- Reduction in the dose of steroids. [ Time Frame: up to 28 days following FMT. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03214289
|Contact: Roni Shouval, MDfirstname.lastname@example.org|
|Chaim Sheba Medical Center||Recruiting|
|Ramat Gan, Israel|
|Principal Investigator:||Roni Shouval, MD||Sheba Medical Center|