Acute Graft Versus Host Disease in IntestineNCT04711967
Prospective Study of FMT for Acute Intestinal GVHD After Allo-HSCT
A study testing Fecal Microbiota Transplantation and drug in people with Acute Graft Versus Host Disease in Intestine, run by Qilu Hospital of Shandong University at 2 sites in China.
Trial summary
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Graft Versus Host Disease in Intestine
- What is being tested?
- Fecal Microbiota Transplantation and drug
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesChina
- Study dates
- 10 Mar 2021to 31 Dec 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- received allo-HSCT due to a hematopoietic disease
- corticosteroid resistant/dependent intestinal GVHD
- ECOG≤2
- Sign informed Consent
- No major organ dysfunction
Who cannot join
- uncontrolled or severe infections
- patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
- high-risk bleeding
- ANC<0.5×10^9/L or PLT<20x10^9/L
- hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
- patients participating in other clinical trials
- patienta who suffer from mental illness
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking university people's hospital
Beijing, Beijing Municipality, 100044
Meng p Lv, 13701140918
- Not yet recruiting
Shandong university qilu hospital
Jinan, Shandong, 250012
Shuqian Xu, Ph. D, M. D., 18560087013, shuqian.xu@email.sdu.edu.cn
About this study
Official title: Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.
Read the detailed description
Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.
- Being tested
- Fecal Microbiota Transplantation, drug
- Keywords
- Acute-graft-versus-host Disease, Fecal microbiota transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Microbiota TransplantationBiological
fecal microbiota transplantation
drugDrug
drug
| Study group | Role | What they receive |
|---|---|---|
| Fecal Microbiota Transplantation group | Experimental | treat with FMT Receives: Biological: Fecal Microbiota Transplantation |
| Control group | Active comparator | treat with traditional medicine Receives: Drug: drug |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in times of stool
Change in times of stool per day within 28 days after FMT
Measured: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
change in volume of stool
Change in volume of stool per day within 28 days after FMT
Measured: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Secondary outcomes (1)
Change in life quality up to 28 days
The change quality of patients life within 28 days after FMT is assessed by "EORTC Quality of Life measurement Scale QLQ-C30 (V3.0)" with a score ranged 0~100. And the higher the score, the better the functional status and quality of life
Measured: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2021
- Study start10 Mar 2021
- Primary completion1 Jul 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft Versus Host Disease in IntestineStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University People's Hospital
- Responsible party
- Sponsor
- Investigators
- Shuqian Xu, Principal investigator, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04711967
- Sponsor's protocol ID
- 2020SDUCRCC015
- Status last verified
- Jan 2021
- First submitted
- 30 Dec 2020
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Fecal Microbiota Transplantation for Acute Intestinal GVHD After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT04711967
- Acronym / sponsor ID
- 2020SDUCRCC015
- Keywords
- Acute-graft-versus-host Disease, Fecal microbiota transplantation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Collaborators
- Peking University People's Hospital
- Study start
- 10 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 15 Jan 2021 (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.
Acute intestinal GVHD is the main cause of death after allo-HSCT, and FMT is a new treatment method for this disease. In this prospective study, the investigators will recruit intestinal GVHD patients to demonstrate the efficacy and safety of FMT.
Detailed description
Graft-versus-host disease (GVHD) is a common complication of allogeneic hematopoietic stem cell transplantation (allo-HSCT), of which intestinal GVHD is a particularly serious one, which is the main cause of death after allo-HSCT. Recent studies have demonstrated that intestinal flora imbalance is strongly associated with the risk of infection and mortality in patients with allo-HSCT. On the basis of this theory, fecal microbiota transplantation (FMT) may be an effective method for GVHD, that is, fecal suspension from healthy individuals is inputted into the digestive tract of patients through some methods, so as to restore the microbial community diversity of patients. In this prospective study, the investigators aimed to demonstrate the efficacy and safety of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fecal Microbiota Transplantation group | Experimental | Biological: Fecal Microbiota Transplantationtreat with FMT |
| Control group | Active comparator | Drug: drugtreat with traditional medicine |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- received allo-HSCT due to a hematopoietic disease
- corticosteroid resistant/dependent intestinal GVHD
- ECOG≤2
- Sign informed Consent
- No major organ dysfunction
Key exclusion criteria (7 listed)
- uncontrolled or severe infections
- patients with severe liver and kidney function, cardiopulmonary insufficiency, epilepsy, and central nervous system disorder
- high-risk bleeding
- ANC<0.5×10^9/L or PLT<20x10^9/L
- hepatitis B, tuberculosis, syphilis, and HIV antibody positive or acute phase of any infectious disease
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 Transplantationfecal microbiota transplantation | Biological | Fecal Microbiota Transplantation group |
| drugdrug | Drug | Control group |
Primary outcome
change in times of stool
Time frame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Change in times of stool per day within 28 days after FMT
change in volume of stool
Time frame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Change in volume of stool per day within 28 days after FMT
1 secondary outcome
Change in life quality up to 28 days
Time frame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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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.
Shuqian Xu principal investigator
Qilu Hospital of Shandong University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Microbiota Transplantation and drug in people with Acute Graft Versus Host Disease in Intestine, run by Qilu Hospital of Shandong University 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 5 inclusion and 7 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 31 Aug 2021. 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.
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 Shuqian Xu (+86 0531-88382169, shuqian.xu@email.sdu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in times of stool (time frame: day 0,day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 14, day 21 and day 28.). 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 31 Aug 2021.