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NCT06313346: FLORABIOTIC

Effect of a Probiotic on Microbiota Associated with the Immune System and Inflammation.

Completed NA Last updated 19 November 2024
What this trial tests

NA trial testing Probiotic in Probiotic in 60 participants. Completed in 15 June 2024.

Timeline
8 January 2024
Primary endpoint
24 April 2024
15 June 2024

Quick facts

Lead sponsorClinica Universidad de Navarra, Universidad de Navarra
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposeprevention
Enrollment60
Start date8 January 2024
Primary completion24 April 2024
Estimated completion15 June 2024
Sites1 location across Spain

Drugs / interventions tested

Conditions studied

Sponsor

Clinica Universidad de Navarra, Universidad de Navarra

Who can join

Adults 40 to 65, any sex, with Probiotic or Microbiota. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The goal of this randomized clinical trial is to learn about the effect of consuming a probiotic on the microbiota associated with immune health and inflammation in healthy women and men after 6 weeks of intervention. The main questions to answer are: 1. To study changes in the intestinal microbiota associated with immune health and inflammation related to probiotic intake. 2. To evaluate changes in salivary cortisol after ingestion of the probiotic. 3. To compile the number and intensity of catarrhal episodes suffered by the participants along the study. For this purpose, a randomized, double blind parallel study has been designed. Target sample size is 60 subjects. Participants will be allocated in two groups for 6 weeks: * Experimental group (n=30): daily consumption of one probiotic capsule. * Placebo group (n=30): daily consumption of one placebo capsule.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Probiotic

Trials testing the same drug.

Other recruiting trials for Probiotic

Currently open trials in the same condition.

Other Clinica Universidad de Navarra, Universidad de Navarra trials

Trials by the same sponsor.

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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/NCT06313346.

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