Clinical trial NCT04711967: Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT
Official title: Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Graft Versus Host Disease in Intestine
Keywords: Acute-graft-versus-host Disease
Fecal microbiota transplantation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
Collaborators: name: Peking University People's Hospital
First posted: 2021-01-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.

Detailed description: Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.

Eligibility criteria: Inclusion Criteria:

1. received allo-HSCT due to a hematopoietic disease
2. corticosteroid resistant/dependent intestinal GVHD
3. ECOG≤2
4. Sign informed Consent
5. No major organ dysfunction

Exclusion Criteria:

1. uncontrolled or severe infections
2. patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
3. high-risk bleeding
4. ANC\<0.5×10\^9/L or PLT\<20x10\^9/L
5. hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
6. patients participating in other clinical trials
7. patienta who suffer from mental illness

Primary outcomes:
measure: change in times of stool
timeFrame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
measure: change in volume of stool
timeFrame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Secondary outcomes:
measure: Change in life quality up to 28 days
timeFrame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking university people's hospital
state: Beijing
city: Jinan
country: China
facility: Shandong university qilu hospital
state: Shandong
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Shuqian Xu
role: PRINCIPAL_INVESTIGATOR
References: