Polish Microbiome Map

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04169867

Enrollment

1160

Registered

2019-11-20

Start date

2018-01-01

Completion date

2020-12-31

Last updated

2019-11-20

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

Conditions

Healthy Volunteers, Immunotherapy, Melanoma, Metagenome, Microbiome

Keywords

Microbiome, Melanoma, Healthy Volunteers, Immunotherapy, Stool samples, Cancer, Metagenome, Neoplasms, Intestinal microbiota, Nivolumab, Ipilimumab, Atezolizumab

Brief summary

Knowledge about the correlations between the composition of the gut microbiome and a wide range of diseases has substantially increased in recent years. Nonetheless, there is no reference set of information about the microbiome in Poland. The development of such a reference will allow polish scientists conducting research in the field of interaction between gut flora components and such characteristics as lifestyle, certain diseases or patient's responses for treatment. Following the example of such countries as the United States, investigators propose to build a unique set of scientific processed information describing the variability of the polish population microbiome (Polish Microbiome Map). The investigators will provide a reliable dataset that will characterize the gut microbiomes and their diversity in the polish population. Additionally, thanks to the creation of the standard protocol for microbiome data collection the research conducted by the MMP users will be comparable with the information deposited in MMP.

Interventions

BIOLOGICALCollection of stool samples

Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ).

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for Healthy Volunteers group: * Men or women ≥18 years of age * Patients with informed consent to participate in the study. Inclusion Criteria for Melanoma group: * Men or women ≥18 years of age * Patients with melanoma * Patients with informed consent to participate in the study. * Patients receiving routine treatment (immunotherapy using anti-PD1 / anti-PDL1 and / or anti CTLA4 antibodies), financed by the Polish National Health Fund (NFZ). * The applied immunotherapy should be the first or second line of treatment.

Exclusion criteria

* Patients or Healthy Volunteers who are unable to understand, read and / or sign the informed consent * Patients or Healthy Volunteers who can not collect stools * Patients with a fecal transplant * The applied immunotherapy is not the first or second line of treatment.

Design outcomes

Primary

Measure	Time frame	Description
Microbial diversity in stool samples	Inclusion	Microbial DNA - stool samples sequenced by next-generation sequencing platform.
Eating habits and health survey	Inclusion	It includes questions about healthy volunteers' and patients' eating habits that may relate to their health.

Countries

Poland

Contacts

Primary ContactAnna Philips, PhD

gmp.mmp@ibch.poznan.pl+48 61 852 89 19

Backup ContactEmilia Strycharz-Angrecka

emilia.strycharz-angrecka@ardigen.com+48 12 340 94 94

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026