NCT06313346

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

Effect of a Probiotic Consumption on Microbiota Associated with the Immune System and Inflammation in Adult Women and Men (FLORABIOTIC INMUNITARIO).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Volunteers who wish to participate in the study will be interviewed by phone to verify that they meet the main inclusion criteria. Volunteers who meet the main inclusion criteria will be invited to an information and screening visit to resolve any doubts. Volunteers who agree to participate in the study will sign the informed consent and will be randomly allocated to one of the two arms of the study and will be provided with any required material. During the intervention, volunteers will attend two Clinical investigation visits. The first one will be carried out on the first day of the study and the last one will take place at the end of the 6 weeks. In both visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary, physical activity and catarrhal episodes will be taken.

Conditions

• Probiotic
• Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic capsules
DIETARY_SUPPLEMENT	Placebo	Placebo capsules

Timeline

• Start date: 2024-01-08
• Primary completion: 2024-04-24
• Completion: 2024-06-15
• First posted: 2024-03-15
• Last updated: 2024-11-19

Locations

1 site across 1 country: Spain