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NCT06746220: AP-Pro-Fem

Effect of Physical Activity and/or Probiotics on Body Composition and Physiological Parameters in Women

Recruiting now NA Last updated 30 December 2025
What this trial tests

NA trial testing Microbiota sample in Healthy Women in 120 participants. Currently enrolling.

Timeline
16 September 2024
Primary endpoint
15 September 2027
15 December 2027

Quick facts

Lead sponsorCentre Hospitalier Régional d'Orléans
PhaseNA
StatusRecruiting now
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment120
Start date16 September 2024
Primary completion15 September 2027
Estimated completion15 December 2027
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Hospitalier Régional d'Orléans

Who can join

18 and older, female only, with Healthy Women. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a prospective, comparative, double-blind, randomized, monocentric study. The objective of this project is to evaluate the effects on health of probiotic supplementation (PS) with or without physical activity (PA). Participants who meet the study criteria will be randomized into 4 groups: probiotic and physical activity group (A+), probiotic and non-physical activity group (A-), placebo and physical activity group (T+), placebo and non-physical activity group (T-). The probiotics used are Lactibiane® Reference provided by Pileje Laboratory. The study population are healthy women (university students) who do not practice sports. A total of 120 participants will participate. At inclusion, each participant will undergo a medical examination, collect microbiota and salivary samples and perform different tests (questionnaires, assessments of strength and endurance). Then, a follow up phase will last 6 weeks. Each participant will receive a pillbox containing capsules (probiotic or placebo in a double-blind manner). Participants which randomized in the PA groups (A+ and A-) will perform 2 physical activity sessions per week for 6 weeks. At the end of this follow up phase, tests conducting during inclusion will be performed again.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Healthy Women

Currently open trials in the same condition.

Other Centre Hospitalier Régional d'Orléans trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06746220.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing