Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05352269
Other study ID # XBI302CT9001
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 21, 2022
Est. completion date October 2022

Study information

Verified date April 2022
Source Shenzhen Xbiome Biotech Co., Ltd.
Contact Xuemei Liu
Phone 010-83605200-855
Email xuemei.liu@gohealtharo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a two-part, randomized, double-blind, placebo-controlled, single center study to investigate the safety and tolerability of XBI-302 administered orally in healthy volunteers. The hypothesis of this study is that XBI-302 is safe and well tolerated with the proposed dosing regimens.


Read more »

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
XBI-302
Fecal Microbiota Transplantation Capsules
XBI-302 Placebo
XBI-302 Placebo

Locations

Country Name City State
China Bejing Goboard Boren Hospital Beijing

Sponsors (2)

Lead Sponsor Collaborator
Shenzhen Xbiome Biotech Co., Ltd. Beijing Improve-Quality Tech.Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence and severity of all AEs and SAEs The incidence and severity of all AEs and SAEs that are determined to be related to XBI-302 through Day 28. Day 28
Secondary The incidence of all AEs and SAEs The incidence of all AEs and SAEs through Day 28 and Week 12. Day 28 and Week 12
Secondary Change in laboratory data of pre- and post-intervention as a measure of safety. Compare changes laboratory data via hematology, blood chemistry, urinalysis, and routine stool testing before and after using FMT capsules. Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Secondary Change in functions of all organ systems via standard complete physical examinations. Change in functions of all organ systems via standard complete physical examinations. Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Secondary Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations. Change in functions of heart, lungs, abdomen and other organ that involve the gastrointestinal tract and digestive system via targeted physical examinations. Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Secondary Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety. Change in vital signs in ear temperature, pulse, respirations, and blood pressure as a measure of safety. Baseline, Weeks 1, 2, 3, 4, and 12 (if applicable for the arm)
Secondary The incidence of gastrointestinal AEs Compare the incidence of gastrointestinal AEs on the dosing day(s) between treatment groups. Weeks 1, 2, 3, and 4 (if applicable for the arm)
Secondary The level of difficulty of swallowing FMT capsules as a measure of tolerability. Estimate degree of difficulty of swallowing FMT capsules via daily diary cards by selecting easy, ok, hard (must rest frequently to complete all capsules), or very hard (stuck to my throat all the time, took a long time to finish all capsules). Weeks 1, 2, 3, and 4 (if applicable for the arm)
Secondary The subjective experience of the taste acceptance as a measure of tolerability. Estimate degree of taste acceptance of FMT capsules via daily diary cards by selecting none, ok, a strange taste, or strong taste that makes me nauseous. Weeks 1, 2, 3, and 4 (if applicable for the arm)
Secondary The gut microbiome profile Compare the gut microbiome profile before and after the transplantation between treatment groups. Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
Secondary The gut microbiome profile Compare the gut microbiome profile before and after the transplantation between donors and participants. Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
Secondary The colonization of microbiota from donor Compare the effects of diet and lifestyle on the colonization of microbiota from donor before and after FMT. Baseline, Weeks 1, 2, 3, 4, 6, 8, 10, and 12 (if applicable for the arm)
See also
  Status Clinical Trial Phase
Terminated NCT03557749 - Monitoring of Immune and Microbial Reconstitution in (HCT) and Novel Immunotherapies
Completed NCT05121142 - Study of Ruxolitinib for Acute and Chronic Graft Versus Host Disease Phase 1
Completed NCT02175615 - Pharmacological Predictors of Successful Cyclosporine Acute GVHD Prophylaxis in Children Undergoing HSCT
Recruiting NCT05078073 - HBOT in the Treatment and Prevention of aGVHD N/A
Not yet recruiting NCT03605940 - A Study Comparing Corticosteroids Alone Versus Corticosteroids and Extracorporal Photopheresis (ECP) as First-line Treatment of Standard II Acute Graft-versus-host Disease Phase 2
Completed NCT04014790 - RGI-2001 for the Prevention of Acute Graft-vs-Host Disease in Subjects Following Allogeneic Hematopoietic Stem Cell Transplantation Phase 2
Recruiting NCT03148743 - Fecal Microbiota Transplantation in Gut aGVHD Treated
Recruiting NCT03805789 - The Safety and Efficacy of Alpha-1 Antitrypsin (AAT) for the Prevention of Graft-Versus-host Disease (GVHD) in Patients Receiving Hematopoietic Cell Transplant Phase 2/Phase 3
Recruiting NCT04291261 - Extracorporal Photopheresis With UVADEX Plus Standard Steroid Treatment for High Risk Acute Graft-versus-host Disease Phase 2
Recruiting NCT05123040 - Ruxolitinib, Human Chorionic Gonadotropin (uhCG/EGF), and Dose De-escalated Corticosteroids Phase 1/Phase 2
Recruiting NCT04686929 - Abatacept s.c. for aGVHD Prevention in Haplo-HCT Phase 1/Phase 2
Completed NCT03763318 - A Study to Evaluate the Safety, Tolerability, PK, PD, and Clinical Activity of EQ001 in Subjects With aGVHD Phase 1/Phase 2
Recruiting NCT03764228 - Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation N/A
Completed NCT03339297 - An Open-Label Study of Defibrotide for the Prevention of Acute Graft-versus-Host-Disease (AGvHD) Phase 2
Active, not recruiting NCT03847844 - UCMSCs as Front-line Approach of Treatment for Patients With aGVHD Phase 1/Phase 2
Recruiting NCT05149365 - Sitagliptin for Prevention of aGVHD After Alternative Donor Transplantation Phase 3
Not yet recruiting NCT04883918 - ASC930 in Patients With Steroid-Refractory Acute Graft Versus Host Disease (SR-aGVHD) Phase 2
Terminated NCT01220297 - Sirolimus & Mycophenolate Mofetil as GvHD Prophylaxis in Myeloablative, Matched Related Donor HCT Phase 2
Recruiting NCT05263999 - A Study of Itolizumab in Combination With Corticosteroids for the First-Line Treatment of Acute Graft Versus Host Disease (EQUATOR) Phase 3
Not yet recruiting NCT02392780 - Cannabidiol for the Treatment of Severe (Grades III/IV) Acute Graft-versus-host Disease Phase 2