NCT05878444

Evaluation of the Colonization Capacity of a Probiotic Bacterium.

Evaluate the Colonization Capacity of a New Generation Probiotic Within the Project: Valorization of an Intestinal Bacterium as a Functional Ingredient to Prevent the Development of Metabolic Syndrome and Diabetes -BIOPRED

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Valencian Innovation Agency · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to test the colonization of a new generation probiotic in normal weight and overweight/obese people. The main question aims to answer is if our bacteria is able to colonize the human intestine. Participants will recieve a probiotic pill every day during 15 consecutive days and fill in questionaries.

Detailed description

Normal weight and overweight volunteers will be recruited to evaluate the colonization capacity of the bacteria. In this case, stool samples will be taken before starting the intervention (T0), after the treatment (T1) and a week after fiinishing the administration of the probiotic (T2). All the subjects will receive the probiotic supplement in capsules taken daily, 7-8 normal weight subjects will take a concentration of 10\^9-10 CFU and 7-8 overweight subjects will take a concentration of 10\^9-10 CFU.

Conditions

• Obese
• Weight, Body

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Resistant gastrointestinal capsules will be provided daily to the participants.

Timeline

• Start date: 2023-06-01
• Primary completion: 2023-09-30
• Completion: 2024-01-31
• First posted: 2023-05-26
• Last updated: 2023-05-26

Locations

1 site across 1 country: Spain