Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study
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|ClinicalTrials.gov Identifier: NCT03549676|
Recruitment Status : Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : March 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fecal Microbiota Transplantation in GVHD||Biological: Fecal Microbiota Transplantation||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||15 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Fecal Microbiota Transplantation for Treatment of Refractory Graft Versus Host Disease-a Pilot Study|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||May 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: HSCT patients with refractory GVHD
Patients will accept FilmArray Gastrointestinal (GI) panel test before pre-treatment of HSCT and 28±3 days post-HSCT. Patients will receive 50ml fecal microbiota from unrelated healthy donors through nasojejunal tube and monitored under gastroscopy. Patients receiving FMT treatment will be followed for at least 6 months. The ideal follow up time is 2 year. Stool and blood samples will be serially collected and tested (before pre-treatment, 1/3/6/12 months after FMT).
Biological: Fecal Microbiota Transplantation
For patients who do not respond or partial respond for first time FMT treatment, a second time FMT treatment using different donor should be considered.
- Efficacy of FMT in the treatment of refractory GVHD on day 7 [ Time Frame: 7 days following FMT ]Participants will be evaluated on days 7 following FMT. The volume and frequency of daily diarrhoea will be continuous observed and recorded in 7 days.
- Efficacy of FMT in the treatment of refractory GVHD on day 28 [ Time Frame: 28 days following FMT ]Participants will be evaluated on days 28 following FMT. The volume and frequency of daily diarrhoea will be continuous observed and recorded in 28 days.
- Treatment-related AEs and SAEs [ Time Frame: up to 28 days following FMT ]The overall safety of the study will be evaluated with the incidence of all Adverse Events (AEs) and Serious Adverse Events (SAEs) within 28 days following FMT. The relationship of any kind AEs and FMT will be seriously evaluated. Non-serious AEs include: dyspepsia, abdominal pain, nausea, vomiting, diarrhea, constipation, fever, inhalation without mechanical ventilation, etc. SAEs include: death, sepsis, aspiration pneumonia, gastrointestinal hemorrhage, septic shock, etc.
- GVHD severity [ Time Frame: up to 28 days following FMT ]Patients will be evaluated on days 7 and 28 following transplantation for severity of GVHD. GVHD severity is graded by the International Bone Marrow Transplant Registry Severity Index grading system.
- Implantation rate [ Time Frame: through study completion, an average of 6 months ]The data will be compared with patients who had not participated in clinical trials.
- Survival rate [ Time Frame: through study completion, an average of 6 months ]The data will be compared with patients who had not participated in clinical trials.
- Change in biomarkers [ Time Frame: up to 28 days following FMT ]Change in levels of albumin and C-reactive protein between days 0 and days 28 will serve as a secondary endpoint.
- Number of patients with infectious disorders [ Time Frame: through study completion, an average of 6 months ]Evaluation of FMT activity on infectious disorder.
- Quality of Life [ Time Frame: up to 6 months following FMT ]The quality of life of patients will be measured using a standardized quality of life questionnaire (EORTC QLQ-C30) prior to transplantation and on days 7, 14, 21, 28 and 180 following transplantation.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03549676
|Contact: Qing Cao, MD||+86 email@example.com|
|Contact: Yue Tao, PhD||+86 firstname.lastname@example.org|
|Study Director:||Qing Cao, MD||Shanghai Children's Medical Center|