NCT06602388

Brief Summary

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
21mo left

Started Dec 2024

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

September 16, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 19, 2024

Completed
3 months until next milestone

Study Start

First participant enrolled

December 30, 2024

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

September 20, 2024

Status Verified

September 1, 2024

Enrollment Period

3 years

First QC Date

September 16, 2024

Last Update Submit

September 19, 2024

Conditions

Keywords

Biologicalsamplescollection

Outcome Measures

Primary Outcomes (1)

  • The number of analyzable samples collected for scientific purposes.

    The number of analyzable samples collected for scientific purposes at the end of inclusion periode

    3 years after the first inclusion

Study Arms (1)

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

Interventions

Collection of biological samples from healthy volunteers: Stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair

Healthy volunteers (Bioaster employees)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy volunteers (Bioaster employees)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Biospecimen

Retention: SAMPLES WITHOUT DNA

biological samples: stool, urine, saliva, buccal swab, nasal swab, superficial skin swab, hair

Study Officials

  • Cyril GUYARD, Study Director

    Bioaster

    STUDY DIRECTOR
  • Dr Xavier MORGE

    Bioaster

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

December 30, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

September 20, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share