Human Internal BIOASTER's Samples Collection (HIBISCUS)

September 19, 2024 updated by: Bioaster

Non-interventional, Monocentric Study Aimed at Building up a Collection of Biological Samples Collected From Bioaster Collaborators for Scientific Purposes

BIOASTER is a Technological Research Institute dedicated to microbiology and infectious diseases. BIAOSTER s areas of expertise are organized around four research programs: 1/ Antimicrobials; 2/ Vaccines; 3/ Microbiota; 4/ Diagnostics.

Hibiscus is a non-interventional, monocentric study aimed at building up a a collection of biological samples (stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair) collected from BIOASTER employees. These samples to be used for scientific purposes including the technological development of Bioaster s collaborative and in-house research projects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

Study Contact Backup

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy volunteers (Bioaster employees)

Description

Inclusion Criteria:

Some inclusion criteria can be defined according to the needs of the scientific objective. For example, it is up to volunteers to decide whether or not to participate if they meet the following criteria:

  • Age criteria (e.g.: specific, non-identifying range sought: 30-40 years)
  • BMI criteria (for example: BMI between 18.5 and 29 kg/m2)
  • Gender criteria (e.g.: women only)

Exclusion Criteria:

Some of the following non-inclusion criteria may be defined according to the needs of the project:

  • Minor subject
  • Health criteria (e.g. presence or absence illness/infection/vaccination/allergy/anti-infective treatment in the last 3 months prior to the date of sampling)
  • Smoker status
  • Severe chronic illness (active cancer, HIV, severe renal failure, ongoing severe heart, liver or biliary disorders, arthritis)
  • Diagnosed acute or chronic gastrointestinal disease or complication (e.g. celiac disease, gastroesophageal reflux, gastric or duodenal ulcer, Crohn's disease, hemorrhoids, irritable bowel syndrome),

In all cases, it will be requested that volunteers with the following criteria do not participate in the study:

  • Pregnant or breast-feeding women
  • Subjects under curatorship or guardianship
  • Subjects under legal protection.

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 (Bioaster employees)
Collection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair
Other: Biological sampling
Collection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of analyzable samples collected for scientific purposes.
Time Frame: 3 years after the first inclusion
The number of analyzable samples collected for scientific purposes at the end of inclusion periode
3 years after the first inclusion

Collaborators and Investigators

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

Sponsor

Bioaster

Investigators

  • Study Director: Cyril GUYARD, Study Director, Bioaster
  • Principal Investigator: Dr Xavier MORGE, Bioaster

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 (Estimated)

December 30, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 16, 2024

First Posted (Actual)

September 19, 2024

Study Record Updates

Last Update Posted (Actual)

September 20, 2024

Last Update Submitted That Met QC Criteria

September 19, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024-A00323-44

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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