NCT03812705CompletedPhase 2
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
Source: ClinicalTrials.gov · Last updated 23 Apr 2024
Brief summary (registry, in English)
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200\~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 6 (actual)
- First submitted
- 19 Jan 2019
- Start date
- 13 Dec 2018
- Primary completion date
- 30 Mar 2024
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Diseases
- Childhood cancers
- NCT number
- NCT03812705
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 6
- From 13 Dec 2018 to the primary completion date, 30 Mar 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
Lab values
- Absolute neutrophil count (ANC) \<0.5×10e9/L or platelet count (PLT) \< 20×10e9/L
Other
- Participating other clinical trials.
- Pregnant women.
Who the study is looking for
- Age\>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
- Signed consent form.
Age in the registry: 14 years to 60 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Jiao Tong University Affilated First People's Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
| Shanghai Jiao Tong University Affilated Shanghai General Hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.