Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06313346
Study type Interventional
Source Clinica Universidad de Navarra, Universidad de Navarra
Contact Fermín I Milagro Yoldi, PhD
Phone +34948425600
Email fmilagro@unav.es
Status Recruiting
Phase N/A
Start date January 8, 2024
Completion date June 15, 2024

See also
  Status Clinical Trial Phase
Withdrawn NCT03239197 - Project SHARE (motherS Have All the Right microbEs) N/A
Completed NCT04117802 - Effects of Maple Syrup on Gut Microbiota Diversity and Metabolic Syndrome N/A
Recruiting NCT06144905 - Norwegian Microbiota Study in Anorexia Nervosa
Completed NCT05864352 - The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
Recruiting NCT04138979 - Intestinal Microbiota of Breast Cancer Patients Undergoing Chemotherapy
Recruiting NCT04132713 - Study on Skin Microbiome of HFS
Completed NCT05726435 - Effects of Soluble Dietary Fiber on Sport Efficiency and Fatigue Delay in Top Basketball Players N/A
Recruiting NCT02695784 - Probiotics After Discharge Phase 4
Completed NCT03543891 - Intestinal Microbiota and Thyroid Cancer
Completed NCT05242913 - Effects of Resistant Potato Starch on the Gut Microbiota N/A
Recruiting NCT04200521 - The Effect of Bariatric Procedures on Gut Microbiota in Obese Individuals in United Arab Emirates and Lebanon
Recruiting NCT05891977 - Effect of Tomato Paste Consumption on the Microbiota-gut-brain Axis in Healthy Adults N/A
Completed NCT02988349 - Ecological Effect of Arginine Dentifrice on Oral Microbiota N/A
Completed NCT05352724 - Clinical Trial to Evaluate the Efficacy of a Sport Drink After High-intensity Aerobic Exercise N/A
Completed NCT04674839 - The Impact of MS-20 on Gut Microbiota Composition in Adult Individuals N/A
Completed NCT03754504 - Effects of Cranberry Powder Supplements on Gut Microbiota Diversity and Metabolic Syndrome N/A
Completed NCT05394948 - Circular Economy and the Design of Healthy and Sustainable Food and Ingredients N/A
Terminated NCT03752372 - Microbiome Alterations in IL10RA-deficient Patients After HSCT
Completed NCT05974124 - Effectiveness of Ophthalmic Antiseptic Preparations N/A
Recruiting NCT02005003 - Cognitive and Metabolic Effects of a Probiotic Supplement N/A