Modification of the Human Colon and Oral Microbiome by Allogenic HSCT

Modification of the Human Colon and Oral Microbiome by Allogeneic HSCT in Recipients and Correlation With the Microbiome of the Donor

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03942159

Enrollment

Registered

2019-05-08

Start date

2019-05-14

Completion date

2023-03-31

Last updated

2020-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HSCT, Human Microbiome

Keywords

Microbiome, stem cell transplantation

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 18 Years

Healthy volunteers

Inclusion criteria

* indications to alloHSCT * nursing healthy donors 3-55 y.o.

Exclusion criteria

* unable to give samples for the test * graft rejection * previous HSCT

Design outcomes

Primary

Measure	Time frame	Description
beta-index dynamics	7 days before HSCT	biodiversity (beta-index) dynamics between time points before and after HSCT

Secondary

Measure	Time frame	Description
Proportion of patients with microbial domination after HSCT	7 days after HSCT	evaluation of the dynamics of the microbial domination between time points before and after HSCT
Shannon-index dynamics	7 days before HSCT	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
ROC (receiver operating characteristic)-curve of NGS (new-generation sequence)	7 days before HSCT	sensitivity of NGS as a method of biodiversity evaluation

Countries

Russia

Contacts

Primary ContactZhanna Shekhovtsova

zhanna.shekhovtsova@fccho-moscow.ru84956647078

Outcome results