Human MicrobiomeNCT03942159
Modification of the Human Colon and Oral Microbiome by Allogenic HSCT
An observational study of Human Microbiome and HSCT, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
Trial summary
Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Human Microbiome, HSCT
- How many people
- 15 participants
- Where
- 1 siteRussia
- Study dates
- 14 May 2019to Mar 2023
- Phase
- Observational
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology
Who may be able to join
- indications to alloHSCT
- nursing healthy donors 3-55 y.o.
Who cannot join
- unable to give samples for the test
- graft rejection
- previous HSCT
Trial locations and contacts
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
Dmitry Rogachev National Research Center of Pediatric Hematology, Oncology and Immunology
Moscow, 117997
Zhanna Shekhovtsova, MD, 4956647078 ext. 7538, zhanna.shekhovtsova@fccho-moscow.ru
Michael Maschan, PhD
About this study
Official title: Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.
- Conditions
- Human Microbiome, HSCT
- Keywords
- Microbiome, stem cell transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Donors | HLA-matched or haploidentical nursing relative donors | |
| Patients | recipients of allogeneic HSCT |
What is being measured
The primary outcome is the main question the study is designed to answer.
beta-index dynamics
biodiversity (beta-index) dynamics between time points before and after HSCT
Measured: 7 days before HSCT
beta-index dynamics
biodiversity (beta-index) dynamics between time points before and after HSCT
Measured: 7 days after HSCT
beta-index dynamics
biodiversity (beta-index) dynamics between time points before and after HSCT
Measured: 60 days after HSCT
Secondary outcomes (8)
Proportion of patients with microbial domination after HSCT
evaluation of the dynamics of the microbial domination between time points before and after HSCT
Measured: 7 days after HSCT
Proportion of patients with microbial domination after HSCT
evaluation of the dynamics of the microbial domination between time points before and after HSCT
Measured: 60 days after HSCT
Shannon-index dynamics
biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT
Measured: 7 days before HSCT
Shannon-index dynamics
biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT
Measured: 7 days after HSCT
Shannon-index dynamics
biodiversity (Shannon-index - an information statistic index, which means it assumes all species are represented in a sample and that they are randomly sampled) dynamics between time points before and after HSCT
Measured: 60 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
sensitivity of NGS as a method of biodiversity evaluation
Measured: 7 days before HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
sensitivity of NGS as a method of biodiversity evaluation
Measured: 7 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
sensitivity of NGS as a method of biodiversity evaluation
Measured: 60 days after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2019
- Study start14 May 2019
- Primary completionMar 2021 (estimated)
- Study completionMar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human MicrobiomeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and Immunology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Maschan, PhD, Principal investigator, National Research Center for Pediatric Hematology , Moscow, Russian Federation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03942159
- Sponsor's protocol ID
- NCHPOI-2019-01
- Status last verified
- Apr 2020
- First submitted
- 29 Apr 2019
- Last updated
- 7 Apr 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor
- ClinicalTrials.gov ID
- NCT03942159
- Acronym / sponsor ID
- NCHPOI-2019-01
- Conditions
- Human Microbiome, HSCT
- Keywords
- Microbiome, stem cell transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Federal Research Institute of Pediatric Hematology, Oncology and ImmunologyUniversity, hospital or other
- Study start
- 14 May 2019 (actual)
- Primary completion
- Mar 2021 (estimated)
- Study completion
- Mar 2023 (estimated)
- First posted
- 8 May 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.
Allogenic HSCT brings significant changes in biodiversity and composition of the gut microbiome through antibiotic usage, the mucosal damage due to the chemo- and radiotherapy toxicity; compromised oral nutritional intake and graft-versus-host disease with gut damage as the complication. Aim of the study is to investigate the composition of the microbiota in both recipient and nursing relative donor, reveal changes in biodiversity after HSCT via 3-time points V3V4 16S rRNA and NGS sequencing of the colon and oral swabs, 3-indoxyl-sulfate measurement in the urine.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donors | – | –HLA-matched or haploidentical nursing relative donors |
| Patients | – | –recipients of allogeneic HSCT |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric recipients and their donors receiving treatment in the Dmitry Rogachev National Medical Research Center Of Pediatric Hematology, Oncology, and Immunology
Key inclusion criteria (2 listed)
- indications to alloHSCT
- nursing healthy donors 3-55 y.o.
Key exclusion criteria (3 listed)
- unable to give samples for the test
- graft rejection
- previous HSCT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
beta-index dynamics
Time frame: 7 days before HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
beta-index dynamics
Time frame: 7 days after HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
beta-index dynamics
Time frame: 60 days after HSCT
biodiversity (beta-index) dynamics between time points before and after HSCT
8 secondary outcomes
Proportion of patients with microbial domination after HSCT
Time frame: 7 days after HSCT
Proportion of patients with microbial domination after HSCT
Time frame: 60 days after HSCT
Shannon-index dynamics
Time frame: 7 days before HSCT
Shannon-index dynamics
Time frame: 7 days after HSCT
Shannon-index dynamics
Time frame: 60 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time frame: 7 days before HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time frame: 7 days after HSCT
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)
Time frame: 60 days after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2020.
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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.
Michael Maschan, PhD principal investigator
National Research Center for Pediatric Hematology , Moscow, Russian Federation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Microbiome and HSCT, run by Federal Research Institute of Pediatric Hematology, Oncology and Immunology at 1 site in Russia.
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 2 inclusion and 3 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 7 Apr 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 Russia. 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 Zhanna Shekhovtsova (84956647078 ext. 7538, zhanna.shekhovtsova@fccho-moscow.ru), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
beta-index dynamics (time frame: 7 days before HSCT). The study lists 3 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 7 Apr 2020.