Hematopoietic and Lymphoid Cell NeoplasmPhase 2FEMITGIGVHDNCT03812705
Fecal Microbiota Transplantation for Steroid Resistant/Dependent Acute GI GVHD
A Phase 2 study testing fecal microbiome transplantation in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Read more about this study
- Who is it for?
- Ages 14 to 60 years
- Conditions the study is for
- Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- fecal microbiome transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 13 Dec 2018to 15 Apr 2024
- Phase
- Phase 2
- 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 14 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
- Signed consent form.
Who cannot join
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
- Participating other clinical trials.
- Pregnant women.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Shanghai Jiao Tong University Affilated First People's Hospital
Shanghai, Shanghai Municipality, 200080
Shanghai Jiao Tong University Affilated Shanghai General Hospital
Shanghai, Shanghai Municipality, 200080
About this study
Official title: Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.
Read the detailed description
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD).
Inclusion criteria:
- Age>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- ECOG score ≤2;
- signed consent form.
Exclusion criteria:
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
- Participating other clinical trials.
- Pregnant women.
Treatment:
- Stop antibiotics treatment 1 day before FMT;
- Fasting food 6 hours before FMT;
- Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;
- Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
- If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response;
- If patient's condition is not improved after the second FMT, stop FMT.
Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response.
Minor endpoints:
- Time to response of acute gastrointestinal GVHD;
- Duration of response of acute gastrointestinal GVHD.
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- fecal microbiome transplantation
- Keywords
- allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fecal microbiome transplantationBiological
- Stop antibiotics treatment 1 day before fecal microbiome transplantation;
- Fasting food 6 hours before fecal microbiome transplantation;
- Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention;
- Perform fecal microbiome transplantation under colonoscopy or gastroscopy;
- Perform up to 4 times if patient response;
- Stop if no response after twice fecal microbiome transplantation.
| Study group | Role | What they receive |
|---|---|---|
| fecal microbiome transplantation | Experimental | 1. Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
2. If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response;
3. If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation. Receives: Biological: fecal microbiome transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response rate
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
Measured: 12 weeks within FMT
Secondary outcomes (2)
Time to response
Time to response of acute gastrointestinal GVHD
Measured: 12 weeks within FMT
Duration of response
Duration of response of acute gastrointestinal GVHD
Measured: 12 weeks within FMT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2019
- Study start13 Dec 2018
- Primary completion30 Mar 2024
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphoid Cell NeoplasmStudies of the same condition, open and under way.
- More trials run by Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liping Wan, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Liping Wan, MD, Principal investigator, Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03812705
- Sponsor's protocol ID
- SHSYXY-FMT-GVHD-2018002
- Acronym
- FEMITGIGVHD
- Status last verified
- Apr 2024
- First submitted
- 19 Jan 2019
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Microbiota Transplantation for the Treatment of Steroid Resistant/Dependent Acute Gastrointestinal Graft Versus Host Disease
- ClinicalTrials.gov ID
- NCT03812705
- Acronym / sponsor ID
- FEMITGIGVHD / SHSYXY-FMT-GVHD-2018002
- Conditions
- Hematopoietic and Lymphoid Cell Neoplasm
- Keywords
- allogeneic hematopoeitic stem cell transplantation, acute gastrointestinal graft versus host disease, fecal microbiome transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Shanghai General Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 13 Dec 2018 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 23 Jan 2019 (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.
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD). The patient will cease antibiotics treatment 1 day before FMT, and stop taking food 6 hours before FMT. Patients will be given Ondansetron intravenously 1 hour before FMT. Patients will be injected 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenal tube by gastroscopy. If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response. If patient's condition is not improved after the second FMT, ceasing FMT.
Detailed description
The purpose of this study is to evaluate the efficacy and safety of fecal microbiome transplantation in patients with steroid resistant/dependent acute gastrointestinal graft-versus-host disease (GVHD).
Inclusion criteria:
- Age>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- ECOG score ≤2;
- signed consent form.
Exclusion criteria:
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
- Participating other clinical trials.
- Pregnant women.
Treatment:
- Stop antibiotics treatment 1 day before FMT;
- Fasting food 6 hours before FMT;
- Give Ondansetron intravenously 1 hour before FMT for vomiting prevention;
- Injection of 200~300 ml fecal microbiome fluid to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy;
- If patient's condition is stable or improved within 1 week, second FMT may be performed 1 week later, up to 4 times will be performed if patient response;
- If patient's condition is not improved after the second FMT, stop FMT.
Major endpoint Response rate of acute gastrointestinal GVHD with 12 weeks after FMT, including complete response and partial response.
Minor endpoints:
- Time to response of acute gastrointestinal GVHD;
- Duration of response of acute gastrointestinal GVHD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- fecal microbiome transplantation for patients with steroid resistant/dependent acute gastroinstestinal graft versus host disease
| Arm | Type | Receives |
|---|---|---|
| fecal microbiome transplantation | Experimental | Biological: fecal microbiome transplantation1. Perform fecal microbiome transplantation to patient under colonoscopy or gastroscopy: injection of 200~300 ml fecal microbiome fluid as fecal microbiome transplantation to left colon by Colonoscopy or duodenum through duodenum tube by gastroscopy; 2. If patient's condition is stable or improved within 1 week, second fecal microbiome transplantation may be performed 1 week later, up to 4 times will be performed if patient response; 3. If patient's condition is not improved after the second fecal microbiome transplantation, stop fecal microbiome transplantation. |
Who may qualify
- Ages
- 14 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age>= 14 yrs ≤60 yrs.
- Diagnosed with hematological diseases.
- Recipients of allogeneic peripheral blood stem cell transplantation.
- Steroid resistant/dependent acute intestinal graft-versus-host disease (GVHD) within 100 days post-transplantation. The definition of steroid resistant/dependent acute intestinal GVHD is progression within 3 days of starting treatment or an incomplete response by 7 days or recurrence after initial dose reduction.
- Eastern Cooperative Oncology Group (ECOG) score ≤2;
Key exclusion criteria (6 listed)
- Complicated with uncontrolled severe infection except intestine and colon.
- High risk of hemorrhage, dysfunction of coagulation, active gastrointestinal hemorrhage;
- Absolute neutrophil count (ANC) <0.5×10e9/L or platelet count (PLT) < 20×10e9/L
- Severe organ dysfunction, including heart failure, respiratory failure, renal failure, epilepsy or central nervous system dysfunction.
- Participating other clinical trials.
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 microbiome transplantation1. Stop antibiotics treatment 1 day before fecal microbiome transplantation; 2. Fasting food 6 hours before fecal microbiome transplantation; 3. Give Ondansetron intravenously 1 hour before fecal microbiome transplantation for vomiting prevention; 4. Perform fecal microbiome transplantation under colonoscopy or gastroscopy; 5. Perform up to 4 times if patient response; 6. Stop if no response after twice fecal microbiome transplantation. | Biological | fecal microbiome transplantation |
Primary outcome
Response rate
Time frame: 12 weeks within FMT
Response rate of acute gastrointestinal GVHD after FMT, including complete response and partial response.
2 secondary outcomes
Time to response
Time frame: 12 weeks within FMT
Duration of response
Time frame: 12 weeks within FMT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
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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.
Liping Wan, MD principal investigator
Shanghai Jiao Tong University Affiliated Shanghai General Hospiatal
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing fecal microbiome transplantation in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response rate (time frame: 12 weeks within FMT). 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 23 Apr 2024.