HealthPhase 1NCT07285317
Safety and Tolerability Evaluationof Phascolarcobacterium Faecium
A Phase 1 study testing Bacterium P. faecium in people with Health and Obesity Type 2 Diabetes Mellitus, run by Spanish National Research Council at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Health, Obesity Type 2 Diabetes Mellitus, Obesity & Overweight
- What is being tested?
- Bacterium P. faecium
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 1 Feb 2024to 31 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years
- stable body weight and dietary habits during the previous three months
- written informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Spain1 site
Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
Valencia
About this study
Official title: 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.
Read the 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.
- Being tested
- Bacterium P. faecium
- Keywords
- Gut microbiota, Obesity, Metabolic health, Probiotic, Phascolarctobacterium faecium
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacterium P. faeciumDietary supplement
The participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days.
| Study group | Role | What they receive |
|---|---|---|
| P. faecium in healthy normal weight individuals | Experimental | 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. Receives: Dietary Supplement: Bacterium P. faecium |
| P. faecium in overweight individuals with mild alterations in glucose homeostasis | Experimental | 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. Receives: Dietary Supplement: Bacterium P. faecium |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start1 Feb 2024
- Primary completion30 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish National Research Council
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yolanda Sanz Herranz, Spanish National Research Council
- Investigators
- Yolanda Sanz, Professor, Principal investigator, Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285317
- Sponsor's protocol ID
- 217/2023
- Status last verified
- Dec 2025
- First submitted
- 14 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liebana-Garcia R, Lopez-Almela I, Olivares M, Romani-Perez M, Manghi P, Torres-Mayo A, Tolosa-Enguis V, Flor-Duro A, Bullich-Vilarrubias C, Rubio T, Rossini V, Segata N, Sanz Y. Gut commensal Phascolarctobacterium faecium retunes innate immunity to mitigate obesity and metabolic disease in mice. Nat Microbiol. 2025 Jun;10(6):1310-1322. doi: 10.1038/s41564-025-01989-7. Epub 2025 May 6.
PubMed 40328980
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo Exploratorio Para Evaluar la Tolerancia de Una Bacteria Con Potencial probiótico (Phascolarcobacterium Faecium) de Nueva generación Para Proteger la Salud metabólica en Humanos
- ClinicalTrials.gov ID
- NCT07285317
- Acronym / sponsor ID
- 217/2023
- Keywords
- Gut microbiota, Obesity, Metabolic health, Probiotic, Phascolarctobacterium faecium
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Spanish National Research CouncilOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| P. faecium in healthy normal weight individuals | Experimental | Dietary Supplement: Bacterium P. faeciumHealthy normal weight individuals will receive a daily dose of P. faecium for 15 days to evaluate the tolerability and safety of short-term administration. |
| P. faecium in overweight individuals with mild alterations in glucose homeostasis | Experimental | Dietary Supplement: Bacterium P. faeciumOverweight individuals with mild alterations in glucose homeostasis will receive P. faecium for 15 days to evaluate its safety and tolerability in the target population. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 years
- stable body weight and dietary habits during the previous three months
- written informed consent
Key exclusion criteria (8 listed)
- the presence of gastrointestinal disorders
- immunodeficiency
- eating disorders
- antibiotic use within one month before the study
- chronic antidiabetic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacterium P. faeciumThe participants will be given Phascolarctobacterium faecium orally (pill form) for 15 consecutive days. | Dietary supplement | P. faecium in healthy normal weight individuals, P. faecium in overweight individuals with mild alterations in glucose homeostasis |
Primary outcome
Incidence of adverse events and general health status
Time frame: 21 days
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.
Systemic safety of P. faecium intake assessed in all the clinical trial participants by biochemical markers
Time frame: 15 days
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.
Tolerability assessment measured by stool habit
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of heartburn.
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of abdominal bloating.
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of constipation.
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of diarrhea.
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of nausea.
Time frame: 15 days
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.
Tolerability assessment measured by the frequency of flatulence.
Time frame: 15 days
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- Background: PubMed 40328980Liebana-Garcia R, Lopez-Almela I, Olivares M, Romani-Perez M, Manghi P, Torres-Mayo A, Tolosa-Enguis V, Flor-Duro A, Bullich-Vilarrubias C, Rubio T, Rossini V, Segata N, Sanz Y. Gut commensal Phascolarctobacterium faecium retunes innate immunity to mitigate obesity and metabolic disease in mice. Nat Microbiol. 2025 Jun;10(6):1310-1322. doi: 10.1038/s41564-025-01989-7. Epub 2025 May 6.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yolanda Sanz, Professor principal investigator
Instituto de Agroquímica y Tecnología de Alimentos (IATA-CSIC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Bacterium P. faecium in people with Health and Obesity Type 2 Diabetes Mellitus, run by Spanish National Research Council at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of adverse events and general health status (time frame: 21 days). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07285317, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.