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Safety and Tolerability Evaluationof Phascolarcobacterium Faecium

NCT07285317 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-12-16

No results posted yet for this study

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.

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Bacterium P. faecium

The participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days.

Sponsors & Collaborators

  • Spanish National Research Council

    lead OTHER_GOV

Principal Investigators

  • Yolanda Sanz, Professor · Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-02-01
Primary Completion
2025-01-30
Completion
2025-01-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07285317 on ClinicalTrials.gov