Safety and Tolerability Evaluationof Phascolarcobacterium Faecium

Spanish National Research Council

Status and phase: Completed; Phase 1

Conditions: Obesity & Overweight; Health; Obesity Type 2 Diabetes Mellitus

Treatments: Dietary Supplement: Bacterium P. faecium

Study type: Interventional

Funder types: Other

Identifiers

NCT07285317

217/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18-65 years
• stable body weight and dietary habits during the previous three months
• written informed consent

Exclusion criteria

• the presence of gastrointestinal disorders
• immunodeficiency
• eating disorders
• antibiotic use within one month before the study
• chronic antidiabetic therapy
• substance (drug) abuse
• restrictive diets
• any other condition deemed inappropriate for participation by the clinician

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

P. faecium in healthy normal weight individuals

Experimental group

Description:

Healthy normal weight individuals will receive a daily dose of P. faecium for 15 days to evaluate the tolerability and safety of short-term administration.

Treatment:

Dietary Supplement: Bacterium P. faecium

P. faecium in overweight individuals with mild alterations in glucose homeostasis

Experimental group

Description:

Overweight individuals with mild alterations in glucose homeostasis will receive P. faecium for 15 days to evaluate its safety and tolerability in the target population.

Treatment:

Dietary Supplement: Bacterium P. faecium