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Safety and Tolerability Evaluationof Phascolarcobacterium Faecium

NCT ID: NCT07285317

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-01-31

Brief Summary

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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

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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

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Health Obesity Type 2 Diabetes Mellitus Obesity & Overweight

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

This study uses a parallel interventional model with two predefined groups: normal-weight individuals and individuals with overweight and mild alterations in glucose metabolism. All participants receive Phascolarctobacterium faecium. All participants follow the same intervention and assessment schedule, allowing for within-group comparisons before and after supplementation, as well as exploratory analyses between the two population subgroups.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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P. faecium in healthy normal weight individuals

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.

Group Type EXPERIMENTAL

Bacterium P. faecium

Intervention Type DIETARY_SUPPLEMENT

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

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

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.

Group Type EXPERIMENTAL

Bacterium P. faecium

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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Bacterium P. faecium

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Spanish National Research Council

OTHER_GOV

Sponsor Role lead

Responsible Party

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Yolanda Sanz Herranz

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yolanda Sanz, Professor

Role: PRINCIPAL_INVESTIGATOR

Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Locations

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Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Valencia, , Spain

Site Status

Countries

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Spain

References

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Xu Y, Xu Z, Zhang J. A comparison of nursing education curriculum in China and the United States. J Nurs Educ. 2002 Jul;41(7):310-6. doi: 10.3928/0148-4834-20020701-07. No abstract available.

Reference Type BACKGROUND
PMID: 12137122 (View on PubMed)

Other Identifiers

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217/2023

Identifier Type: -

Identifier Source: org_study_id