Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05094765
Other study ID # XCT4843002
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date November 1, 2021
Est. completion date March 2, 2023

Study information

Verified date September 2021
Source Shenzhen Xbiome Biotech Co., Ltd.
Contact yanli zhao
Phone 0316-3306412
Email 13121053519@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 15
Est. completion date March 2, 2023
Est. primary completion date March 2, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 1. GVHD within 100 days after allogeneic hematopoietic stem cell transplantation (allo HSCT); 2. Age 18 - 65 years old, regardless of gender; 3. Patients with grade 3 or 4 gastrointestinal involvement (aGVHD) according to the International Alliance (Magic) classification standard; 4. 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. 5. ECoG 3 points or less; 6. Stop prophylactic antibiotics at least 12 hours before FMT treatment; 7. Be able and willing to sign informed consent; 8. Patients who are capable of swallowing capsules and can complete the study; Exclusion Criteria: - 1. There are active but uncontrolled infections, except GVHD complicated with infectious diarrhea; 2. Gastrointestinal perforation, active gastrointestinal bleeding, small intestinal obstruction, toxic megacolon or other serious gastrointestinal diseases not caused by GVHD; 3. Have a history of severe allergic reaction; Or known to be allergic to any ingredient of intestinal bacteria capsule xbi-302; 4. Any serious disease that can increase the risk of patients participating in the study; 5. Female subjects with positive pregnancy test and lactation, or female subjects of childbearing age who refuse to take contraceptive measures during the study; 6. 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. 7. HIV, HBV, HCV and syphilis are positive; 8. After colectomy; 9. Participate in other intervention clinical studies within 4 weeks before the screening period; 10. The expected survival time is less than 12 weeks; 11. 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; 12. There is any situation that the researcher thinks is not suitable for inclusion (any history of medical history, treatment history or abnormal test data that may confuse the results of this study, interfere with the subject's whole participation in the study, or harm the interests of the subject).

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
FMT
Fecal Microbiota Transplantation

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Shenzhen Xbiome Biotech Co., Ltd.

Outcome

Type Measure Description Time frame Safety issue
Other Metabonomics The changes of calprotectin, Is, SCFA and bile acid were compared up to 25 weeks
Other biomarkers The changes of IL-6?IL-8?sTNFR1?sST2?Reg3a?Elafin were compared up to 25 weeks
Other Immunohistochemistry The phenotypes and subsets of CD4 and CD8 positive T cells, B cells, NK cells and monocytes were compared up to 25 weeks
Other Proportion of patients Proportion of patients with hormone dosage = 20mg / day equivalent to equivalent converted dose of prednisolone up to 25 weeks
Other The proportion of patients who stopped antibiotics was compared. up to 25 weeks
Other Percentage of patients Percentage of patients who died due to GVHD up to 25 weeks
Primary ORR assessed by Overall Response Rate (ORR) at Day 28 Day 28
Primary AE assessed all related a grade 3 or above adverse event (AE) at Day 28 Day 28
Secondary AE assessed all related adverse event (AE) up to 25 weeks
Secondary Shannon index changes of Shannon index up to 25 weeks
Secondary colonization bacteria analysis the number and relative abundance of bacteria that originally existed only in the capsule but could still be detected in the stool samples of subjects up to 25 weeks
Secondary PFS Kaplan-Meier Curve up to 25 weeks
See also
  Status Clinical Trial Phase
Completed NCT02942173 - CD45RA Depleted T-cell Infusion for Prevention of Infections After TCRab/CD19-depleted Allo-HSCT Phase 2/Phase 3
Completed NCT02066051 - IPL and Meibomian Gland Expression to Treat Ocular Rosacea Ocular GVHD N/A
Terminated NCT01940796 - Phase I Trial of Brentuximab Vedotin for Refractory Chronic Graft-vs.-Host Disease (GVHD) Phase 1
Not yet recruiting NCT05544448 - In Vitro Effect Study of Interleukin-2 Muteins on Regulatory T Cells of Patients With Different Autoimmune, Allo-immune or Inflammatory Diseases N/A
Completed NCT01295710 - Study of US-ATG-F to Prevent Chronic Graft Versus Host Disease (GVHD) Phase 3
Not yet recruiting NCT06000982 - Comparison of Different Dose of Post-transplantation Cyclophosphamide as Graft Versus Host Disease Prophylaxis Phase 3
Not yet recruiting NCT06075225 - MAP-guided Preemptive Therapy of aGvHD by Ruxolitinib Phase 2
Active, not recruiting NCT03680092 - Comparing Cyclophosphamide and Abatacept With Standard of Care Treatment Following Stem Cell Transplantation Phase 2
Not yet recruiting NCT06083129 - Phase III Study Comparing GVHD Prophylaxis With ATG-thymoglobulin to ATLG-grafalon in Elderly Patients With Acute Myeloid Leukemia or Myelodysplasic Syndrome and Receiving an Allogeneic Hematopoietic Stem Cell Transplantation With a 10/10 HLA Matched Unrelated Donor Phase 3
Active, not recruiting NCT05415410 - Proof-of-concept Trial of Apraglutide in GVHD Phase 2
Completed NCT02441075 - 70% Ethanol for Decontamination of CVL Exposed to Calcineurine Inhibitors Version 1.0, 1/9/2014 N/A
Completed NCT02588339 - Panobinostat (LBH589): Acute Graft Versus Host Disease (aGVHD) Prevention Phase 2
Not yet recruiting NCT06334367 - Prophylaxis of Graft-versus-host Disease With Anti-CD25 Antibody in Patients Underwent HSCT Phase 2
Completed NCT03846479 - Itacitinib for Low Risk GVHD Phase 2
Completed NCT02891603 - A Phase I/II GVHD Prevention Trial Combining Pacritinib With Sirolimus-Based Immune Suppression Phase 1/Phase 2
Completed NCT02712762 - Ocular Surface Disease in Chronic Graft-Versus-Host Disease (GVHD) Patients
Completed NCT03945591 - High-Dose Post-Transplant Cyclophosphamide and Bortezomib (CyBor) for the Prevention of Graft-versus-Host Disease Following Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) Phase 2
Not yet recruiting NCT06411184 - Safety and Efficacy of Treg Cell in the Treatment of GVHD Phase 1/Phase 2
Terminated NCT02338232 - Study of TelmisartanFor the Prevention of Acute GVHD Post Allogeneic Hematopoietic Stem Cell Transplantation N/A
Completed NCT02156479 - Clinical Validation of Lophius Biosciences Kit T-Track® CMV in Allo-HSCT Recipients