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

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.

Study Overview

• Status: Completed
• Conditions: Health; Obesity & Overweight; Obesity Type 2 Diabetes Mellitus
• Intervention / Treatment: Dietary supplement: Bacterium P. faecium

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 1

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Bacterium P. faecium; The participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days.
Experimental: 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.	Dietary supplement: Bacterium P. faecium; The participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of adverse events and general health status	Participants will have access to a 24-hour contact number to report any inconvenience or adverse effects. All adverse effects will be recorded throughout the intervention period and for one additional week after completion. Outcomes will be reported as the presence or absence of adverse effects.	21 days
Systemic safety of P. faecium intake assessed in all the clinical trial participants by biochemical markers	Complete hemogram and biochemical analysis will be permormed at baseline and after bacterum intervention and includes red blood cells, white blood cells, and assessments of lipid profile (triglycerides, total cholesterol, LDL cholesterol, HDL cholesterol, and non-HDL cholesterol), renal function (urea, creatinine, and uric acid), hepatic function (total protein, AST, and ALT), and glucose homeostasis (glucose, insulin, HbA1c, and HOMA-IR). All parameters will be measured using standard units commonly applied in clinical practice, and results will be compared before and after the intervention. It will be interpreted as either unchanged or altered relative to baseline values.	15 days
Tolerability assessment measured by stool habit	To assess the tolerability of P. faecium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, capturing both weekly bowel movement frequency and stool consistency using the Bristol Stool Scale. Stool habits will be evaluated by integrating these two variables: a normal habit will be defined as 4-14 bowel movements per week together with a Bristol score of 3-5, whereas any deviation from these ranges will be classified as an altered stool habit.	15 days
Tolerability assessment measured by the frequency of heartburn.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of heartburn. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days
Tolerability assessment measured by the frequency of abdominal bloating.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of abdominal bloating. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days
Tolerability assessment measured by the frequency of constipation.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of constipation. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days
Tolerability assessment measured by the frequency of diarrhea.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of diarrhea. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days
Tolerability assessment measured by the frequency of nausea.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of nausea. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days
Tolerability assessment measured by the frequency of flatulence.	Use of probiotic bacteria may occasionally elicit mild gastrointestinal discomfort, including bloating, gas or abdominal cramps. To assess the tolerability of the tested bacterium, participants will complete gastrointestinal symptom questionnaires before and after the intervention, which also capture the frequency of flatulence. Response options include: "all the time," "most of the time," "sometimes," "a few times," and "never." Changes in frequency will be compared between pre- and post-treatment assessments.	15 days

Collaborators and Investigators

• Sponsor: Spanish National Research Council
• Investigators: Principal Investigator: Yolanda Sanz, Professor, Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 31, 2025

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: December 2, 2025
• First Posted (Actual): December 16, 2025

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 2, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; Gut microbiota; Probiotic; Metabolic health; Phascolarctobacterium faecium
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity
• Other Study ID Numbers: 217/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No