Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT

Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04711967

Enrollment

Registered

2021-01-15

Start date

2021-03-10

Completion date

2023-12-31

Last updated

2021-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Graft Versus Host Disease in Intestine

Keywords

Acute-graft-versus-host Disease, Fecal microbiota transplantation

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.

Interventions

BIOLOGICALFecal Microbiota Transplantation

fecal microbiota transplantation

DRUGdrug

drug

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
change in times of stool	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	Change in times of stool per day within 28 days after FMT
change in volume of stool	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	Change in volume of stool per day within 28 days after FMT

Secondary

Measure	Time frame	Description
Change in life quality up to 28 days	day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.	The change quality of patients life within 28 days after FMT is assessed by EORTC Quality of Life measurement Scale QLQ-C30 (V3.0) with a score ranged 0\ 100. And the higher the score, the better the functional status and quality of life

Countries

China

Contacts

Primary ContactShuqian Xu

shuqian.xu@email.sdu.edu.cn+86 0531-88382169

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026