Fecal Microbiota Transplant (FMT) Capsule for Improving the Efficacy of GI-aGVHD

NCT05094765 | Unknown Early Phase 1

• 1 other identifier: XCT4843002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to determine whether the fecal microbiota transplant (FMT) capsule improves the response rate of GI-aGVHD in patients with glucocorticoid-refractory acute graft vs. host disease after allogeneic stem cell transplantation

Conditions

GVHD

Outcome Measures

Primary Outcomes (2)

• ORR

  assessed by Overall Response Rate (ORR) at Day 28

  Day 28

• AE

  assessed all related a grade 3 or above adverse event (AE) at Day 28

  Day 28

Secondary Outcomes (4)

• AE

  up to 25 weeks

• Shannon index

  up to 25 weeks

• colonization bacteria analysis

  up to 25 weeks

• PFS

  up to 25 weeks

Other Outcomes (6)

• Metabonomics

  up to 25 weeks

• biomarkers

  up to 25 weeks

• Immunohistochemistry

  up to 25 weeks

Study Arms (1)

FMT

EXPERIMENTAL

60 capsules per day for 2 day

Biological: FMT

Interventions

FMT BIOLOGICAL

Fecal Microbiota Transplantation

FMT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. GVHD within 100 days after allogeneic hematopoietic stem cell transplantation (allo HSCT);
• \. Age 18 - 65 years old, regardless of gender;
• \. Patients with grade 3 or 4 gastrointestinal involvement (aGVHD) according to the International Alliance (Magic) classification standard;
• \. Patients with glucocorticoid resistant GI aGVHD are diagnosed. According to the expert consensus of Chinese allogeneic hematopoietic stem cell transplantation for the treatment of hematological diseases (III) - acute graft-versus-host disease (2020 Edition), the definition of glucocorticoid resistant acute GVHD is Thomas' hematopoietic cell transplantation: stem cell transplantation (5th Edition) Glucocorticoid resistance was defined as PD at 3 days, NR at 7 days or Cr not reached at 14 days after first-line treatment.
• \. ECoG 3 points or less;
• \. Stop prophylactic antibiotics at least 12 hours before FMT treatment;
• \. Be able and willing to sign informed consent;
• \. Patients who are capable of swallowing capsules and can complete the study;

You may not qualify if:

• \. There are active but uncontrolled infections, except GVHD complicated with infectious diarrhea;
• \. Gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by GVHD;
• \. Have a history of severe allergic reaction; Or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302;
• \. Any serious disease that can increase the risk of patients participating in the study;
• \. Female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study;
• \. According to the judgment of the researcher, the patients with high dynamic diarrhea can not stay in the intestine for enough time to dissolve the capsule.
• \. HIV, HBV, HCV and syphilis are positive;
• \. After colectomy;
• \. Participate in other intervention clinical studies within 4 weeks before the screening period;
• \. The expected survival time is less than 12 weeks;
• \. The basic body function test is inferior to the following standards: total neutrophils (neu) \< 0.5 (x109 / L), platelet count (PLT) \< 30 (x109 / L), serum creatinine (CR) \> 1.5 times the maximum normal value (ULN), albumin (ALB) \< 25g / L;

Sponsors & Collaborators

• Shenzhen Xbiome Biotech Co., Ltd.: lead

Central Study Contacts

yanli zhao

CONTACT

0316-3306412; 13121053519@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2021
• First Posted: October 26, 2021
• Study Start: November 1, 2021
• Primary Completion: March 2, 2023
• Study Completion: March 2, 2023
• Last Updated: October 26, 2021

Record last verified: 2021-09