Polish Microbiome Map

November 19, 2019 updated by: Ardigen
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

1160

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Poznań, Poland
        • Recruiting
        • The Institute of Bioorganic Chemistry, Polish Academy of Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers or oncology patients with primary care clinic

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Healthy Volunteers
This cohort will consist of 1000 healthy volunteers from Poland.
Melanoma
This cohort will consist of 160 patients with melanoma.
Biological: Collection 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).
Other Names:
  • Atezolizumab
  • Nivolumab
  • Ipilimumab

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ardigen

Collaborators

National Center for Research and Development, Poland
The Institute of Bioorganic Chemistry, Polish Academy of Sciences

Investigators

  • Principal Investigator: Anna Philips, PhD, The Institute of Bioorganic Chemistry, Polish Academy of Sciences
  • Principal Investigator: Jan Majta, Ardigen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

July 31, 2020

Study Completion (Anticipated)

December 31, 2020

Study Registration Dates

First Submitted

November 18, 2019

First Submitted That Met QC Criteria

November 19, 2019

First Posted (Actual)

November 20, 2019

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

November 19, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMP
  • POIR.04.01.02-00-0025/17 (Other Grant/Funding Number: The National Centre for Research and Development)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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