NCT07285317

Safety and Tolerability Evaluationof Phascolarcobacterium Faecium

Ensayo Exploratorio Para Evaluar la Tolerancia de Una Bacteria Con Potencial probiótico (Phascolarcobacterium Faecium) de Nueva generación Para Proteger la Salud metabólica en Humanos

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Spanish National Research Council · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this interventional study is to assess the safety and tolerability of the daily administratrion of bacterium Phascolarctobacterium faecium in healthy adults with normal weight, and in individuals with overweight and alterations in glucose metabolism. The main questions this study aims to answer are: Is the bacterium intake safe? Is the bacterium intake well tolerated? The objecitves are to assess if the intake of the bacterium is well tolerated by assessing gastrointenstinal symptoms, and safe, by assessing biochemical markers, incidence of adverse events and the general health status. Participants will take daily the bacterium for 15 days. Study assessments include stool collection for microbiota analysis; blood sampling form biochemical tests, anthropometric measurements, and validated questionnaires on diet, physical activity, and perceived health.

Detailed description

A total of 20 adult volunteers will consume a daily dose of Phascolarctobacterium faecium once per day for 15 consecutive days. Stool and blood samples will be collected at baseline and after the intervention; blood draws will be performed following an overnight fasting of at least 8 hours. Participants will also complete online questionnaires assessing sociodemographic characteristics, gastrointestinal symptoms, bowel habits, general health status, physical activity, and dietary habits. In addition, body composition parameters will be evaluated.

Conditions

• Health
• Obesity Type 2 Diabetes Mellitus
• Obesity & Overweight

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Bacterium P. faecium	The participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days.

Timeline

• Start date: 2024-02-01
• Primary completion: 2025-01-30
• Completion: 2025-01-31
• First posted: 2025-12-16
• Last updated: 2025-12-16

Locations

1 site across 1 country: Spain