Steroid-refractory Gastrointestinal Acute Graft Versus Host DiseaseNCT04622475
Efficacy and Safety of FMT Capsule Treating Steroid-refractory GI-aGvHD
A study testing Fecal Microbiota Transplant (FMT) Capsule in people with Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
Trial summary
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease
- What is being tested?
- Fecal Microbiota Transplant (FMT) Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- Nov 2020to Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must be willing and able to sign the informed consent form and complete the follow-up visits.
- 18-75 years old. No gender limitation.
- Patients who can swallow the capsules without chewing.
- Patients who were clinically diagnosed as steroid refractory GI-aGvHD. The diagnosis criteria are: experiencing GI-aGvHD clinical manifestations (e.g., abdominal cramps, diarrhea, stool blood) within 100 days after receiving hematopoietic stem cell transplant (HSCT); having Grade 2-4 gastrointestinal clinical symptoms; excluding diarrhea caused solely by pathogen infection; after adequate steroid treatment, disease progression on day 3, or with no change on day 7, or without complete response on day 14.
- Patients who had complicated infection after the diagnosis of aGvHD, but are able to discontinue all the antibiotic therapy 12 hours before receiving FMT treatment.
- ECOG scale ≤3
- Basic body function indexes reach the following criteria: total neutrophil≥0.5*10^9/L, platelet count≥100*10^9/L, serum creatinine ≤1.5×upper limit of normal (ULN) or creatinine clearance≥40 mL/min, albumin≥25g/L.
Who cannot join
- Patients with extremely serious grade IV aGvHD (life-threatening or with serious non-GvHD complication).
- Refractory malignant condition.
- Patients who have received two or more HSCT.
- Patients who have active infection that has not been controlled and must receive antibiotic therapy, including diarrhea (non-GvHD diarrhea) caused by infection or antibiotics, excluding GvHD complicated infective diarrhea.
- Patients who have gastrointestinal perforation or toxic intestinal.
- Patients who have a history of severe allergic reactions.
- Any condition in which PI do not consider it appropriate to participate (e.g., any medical history, treatment history, or abnormal history of testing data that may confuse the study results, or interfere with the patient's full participation in the study, or hurt the patient's benefit)
- Female patients who have positive pregnancy test results or are breastfeeding. Women of childbearing age who refuse to use contraception one month after FMT treatment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital, Southern Medical University
Guangzhou, Guangdong, 510515
Fen Huang, +86-020-62787883, 13826204917@163.com
About this study
Official title: Investigator-initiated Trial to Explore the Efficacy and Safety of Fecal Microbiota Transplant (FMT) Capsule in the Treatment of Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease Patients
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD.
Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection.
Read more
The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.
This study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.
Read the detailed description
This trial is designed to reconstruct the intestinal micro-ecology of patients with steroid-refractory gastrointestinal acute graft versus host disease (GI-aGvHD) by FMT. The primary objective is to evaluate the safety of FMT capsule in the treatment of steroid-refractory GI-aGvHD patients. The secondary objectives are as follows.
To observe the efficacy of FMT capsule in the treatment of steroid-refractory GI-aGvHD 28 days after the first administration.
To explore the characteristics of gut microbiota changes after FMT capsule treating steroid-refractory GI-aGvHD.
To evaluate the safety of FMT capsule treating steroid-refractory GI-aGvHD 12 weeks and 24 weeks after the first administration.
- Being tested
- Fecal Microbiota Transplant (FMT) Capsule
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota Transplant (FMT) CapsuleBiological
When enrolled in the study, subjects will ingest 20 FMT capsules/day orally for 3 consecutive days. If the syndrome is not completely recovered or relapse 14 days after the first administration, the subject will receive a booster dose (20 capsules/day for 3 consecutive days).
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Fecal Microbiota Transplant (FMT) Capsule Receives: Biological: Fecal Microbiota Transplant (FMT) Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of adverse events (AEs)/serious adverse events (SAEs)
The number of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT).
Measured: 28 days
The severity of AEs/SAEs
The severity of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT).
Measured: 28 days
Secondary outcomes (4)
Response rate
GI-aGvHD response rate (Complete response+Partial response) on Day 28 after the first dose of FMT (Day 1 is the last day of the first dose of FMT).
Measured: 28 days
Changes in gut microbiota
Compare the gut microbiota diversity and major bacterial genus before and 28, 43(for subjects recieved 2 dose of FMT), 84 and 168 days after FMT treatment.
Measured: Days 28, 43, 84, and 168
The number of AEs/SAEs
The number of FMT capsule associated AEs/SAEs occurring from the first FMT treatment to Weeks 12 and 24 after the first FMT treatment.
Measured: Weeks 12 and 24
The severity of AEs/SAEs
The severity of FMT capsule associated AEs/SAEs occurring from the first FMT treatment to Weeks 12 and 24 after the first FMT treatment.
Measured: Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2020
- Study startNov 2020 (estimated)
- Primary completionAug 2021 (estimated)
- Study completionJun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-refractory Gastrointestinal Acute Graft Versus Host DiseaseStudies of the same condition, open and under way.
- More trials run by Nanfang Hospital, Southern Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qifa Liu, Nanfang Hospital, Southern Medical University
- Investigators
- Qifa Liu, Principal investigator, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04622475
- Sponsor's protocol ID
- XBI-302CT1004
- Status last verified
- Nov 2020
- First submitted
- 28 Oct 2020
- Last updated
- 10 Nov 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigator-initiated Trial to Explore the Efficacy and Safety of Fecal Microbiota Transplant (FMT) Capsule in the Treatment of Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease Patients
- ClinicalTrials.gov ID
- NCT04622475
- Acronym / sponsor ID
- XBI-302CT1004
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Jun 2022 (estimated)
- First posted
- 10 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gastro-Intestinal Acute Graft Versus Host Disease (GI-aGVHD) is a complication of allogeneic stem cell transplant which is usually treated with steroids. When aGVHD does not respond to steroids it is described as steroid-refractory aGVHD. There is no standard therapy for steroid-refractory GI-aGVHD.
Fecal Microbiota Transplantation (FMT) is the transfer of fecal material from a healthy donor to a patient in order to restore the diversity of the intestinal microbiota. FMT is currently indicated for the treatment of recurrent Clostridium Difficile infection.
The investigators hypothesize that perturbations in the intestinal microbiota following allogeneic hematopoietic stem cell transplantation (HSCT) are essential for the development and propagation of acute graft-versus-host disease. Therefore, modification of HSCT recipients' gut microbiota using fecal transplantation from a healthy donor could be used to treat gut acute GVHD.
This study evaluates safety and feasibility of fecal microbiota transplantation with frozen capsules from healthy donors for the treatment of steroid resistant or steroid dependent acute graft-versus-host disease of the gut.
Detailed description
This trial is designed to reconstruct the intestinal micro-ecology of patients with steroid-refractory gastrointestinal acute graft versus host disease (GI-aGvHD) by FMT. The primary objective is to evaluate the safety of FMT capsule in the treatment of steroid-refractory GI-aGvHD patients. The secondary objectives are as follows.
To observe the efficacy of FMT capsule in the treatment of steroid-refractory GI-aGvHD 28 days after the first administration.
To explore the characteristics of gut microbiota changes after FMT capsule treating steroid-refractory GI-aGvHD.
To evaluate the safety of FMT capsule treating steroid-refractory GI-aGvHD 12 weeks and 24 weeks after the first administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Biological: Fecal Microbiota Transplant (FMT) CapsuleFecal Microbiota Transplant (FMT) Capsule |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients must be willing and able to sign the informed consent form and complete the follow-up visits.
- 18-75 years old. No gender limitation.
- Patients who can swallow the capsules without chewing.
- Patients who were clinically diagnosed as steroid refractory GI-aGvHD. The diagnosis criteria are: experiencing GI-aGvHD clinical manifestations (e.g., abdominal cramps, diarrhea, stool blood) within 100 days after receiving hematopoietic stem cell transplant (HSCT); having Grade 2-4 gastrointestinal clinical symptoms; excluding diarrhea caused solely by pathogen infection; after adequate steroid treatment, disease progression on day 3, or with no change on day 7, or without complete response on day 14.
- Patients who had complicated infection after the diagnosis of aGvHD, but are able to discontinue all the antibiotic therapy 12 hours before receiving FMT treatment.
Key exclusion criteria (8 listed)
- Patients with extremely serious grade IV aGvHD (life-threatening or with serious non-GvHD complication).
- Refractory malignant condition.
- Patients who have received two or more HSCT.
- Patients who have active infection that has not been controlled and must receive antibiotic therapy, including diarrhea (non-GvHD diarrhea) caused by infection or antibiotics, excluding GvHD complicated infective diarrhea.
- Patients who have gastrointestinal perforation or toxic intestinal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Microbiota Transplant (FMT) CapsuleWhen enrolled in the study, subjects will ingest 20 FMT capsules/day orally for 3 consecutive days. If the syndrome is not completely recovered or relapse 14 days after the first administration, the subject will receive a booster dose (20 capsules/day for 3 consecutive days). | Biological | Treatment |
Primary outcome
The number of adverse events (AEs)/serious adverse events (SAEs)
Time frame: 28 days
The number of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT).
The severity of AEs/SAEs
Time frame: 28 days
The severity of FMT capsule associated AEs/SAEs occurring from the first administration of FMT to Day 28 (Day 1 is the last day of the first dose of FMT).
4 secondary outcomes
Response rate
Time frame: 28 days
Changes in gut microbiota
Time frame: Days 28, 43, 84, and 168
The number of AEs/SAEs
Time frame: Weeks 12 and 24
The severity of AEs/SAEs
Time frame: Weeks 12 and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2020.
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RecruitingPhase 3
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Qifa Liu principal investigator
Nanfang Hospital, Southern Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplant (FMT) Capsule in people with Steroid-refractory Gastrointestinal Acute Graft Versus Host Disease, run by Nanfang Hospital, Southern Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fen Huang (13826204917, 13826204917@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of adverse events (AEs)/serious adverse events (SAEs) (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2020.