NCT06248177

Probiotic Effect on Gastrointestinal Symptoms (FLORABIOTIC REFUERZO).

Effect of a Probiotic Consumption on Gastrointestinal Symptoms in Adults Men and Women (FLORABIOTIC REFUERZO).

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Clinica Universidad de Navarra, Universidad de Navarra · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this randomized clinical trial is to evaluate the effect on the microbiota and the reduction in the number and/or intensity of symptoms of gastrointestinal discomfort of consuming a probiotic or placebo for 6 weeks in adult women and men. The main questions to answer are: 1. To study changes in the alpha diversity of the microbiota. 2. To evaluate changes in the salivary cortisol. For this purpose, a randomized, double blind crossover study has been designed. Target sample size is 30 subjects. Participants will be allocated in two groups for 16 weeks (6 weeks consuming one of the products + 4 weeks wash-out period + 6 weeks consuming the other product). * Group 1 (n=15): 6 weeks daily consumption of one probiotic capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one placebo capsule. * Group 2 (n=15): 6 weeks daily consumption of one placebo capsule + 4 weeks wash-out period+ 6 weeks daily consumption of one probiotic 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 4 visits distributed in two phases of 6 weeks separated by 4 weeks of wash-out period. At the beginning and at the end of each phase there will be a clinical visit. In all visits anthropometric and body composition measurements, stool and saliva samples, as well as data about dietary and physical activity will be collected.

Conditions

• Probiotic
• Gastrointestinal Symptoms
• Microbiota

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic capsules
DIETARY_SUPPLEMENT	Placebo	Placebo capsules

Timeline

• Start date: 2024-01-16
• Primary completion: 2024-06-30
• Completion: 2024-07-30
• First posted: 2024-02-08
• Last updated: 2024-11-19

Locations

1 site across 1 country: Spain