Aging, HealthyLONGEVIBIOMENCT07912164
Fecal Microbiota Transplantation (FMT) to Slow Biological Aging
A study testing Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps) in people with Aging, Healthy and Aging and Cognitive Health, run by Human Biome S.A..
Trial summary
The goal of this clinical trial is to evaluate if multi-dose fecal microbiota transplantation (FMT) capsules can safely and effectively slow down biological aging and reduce chronic low-grade inflammation in adults aged 45 to 80 with metabolic neglect. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Aging, Healthy, Aging and Cognitive Health, Inflammation
- What is being tested?
- Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- Dec 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary written informed consent signed prior to any study-related procedures.
- Age between 45 and 80 years (inclusive) at the time of screening.
- Classified as "metabolically neglected" with documented pre-disease conditions or regulated early-stage chronic disorders.
- Accelerated biological aging rate 1.1, OR between 1.05 and 1.099 combined with chronic low-grade inflammation (inflammaging).
- Preserved cognitive function with a Montreal Cognitive Assessment (MoCA) score between 24 and 30 points.
- Physical ability to perform computerized cognitive tests on a touch-screen tablet.
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- Commitment to maintaining stable dietary and physical activity habits throughout the study period.
- Possession of a home freezer and ability to strictly comply with cold-chain storage logistics for investigational products and stool samples.
- Demonstrated ability to swallow large capsules.
- Adequate baseline laboratory parameters (such as blood counts and kidney function).
- For women of childbearing potential: agreement to use a highly effective method of contraception throughout the study and for 30 days post-intervention.
- Readiness to ensure presence at the registered home address to receive scheduled frozen-chain courier shipments.
Who cannot join
- Systemic antibiotic therapy within 12 weeks prior to baseline.
- Supplementation with any commercial pre- or probiotics within 4 weeks prior to baseline.
- Diagnosed malignancy within the past 5 years (except fully cured basal cell carcinoma or cervical cancer in situ).
- Participation in any other clinical study or trial within 30 days prior to consent or during this study.
- Pregnancy, breastfeeding, or planning a pregnancy during the study and for 30 days post-intervention.
- Known hypersensitivity, intolerance, or allergy to any component of the investigational product (MBiotix HBI Caps), placebo, preparation antibiotics (Neomycin, Metronidazole), antibiotic placebo, or bowel cleansing solution (macrogols).
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- Pre-existing hearing loss, chronic tinnitus, or diagnosed vestibular disorder. History of or active peripheral neuropathy of any etiology.
- Myasthenia gravis or other neuromuscular transmission disorders.
- Concurrent, ongoing use of loop diuretics, other aminoglycoside antibiotics, or known nephrotoxic drugs.
- Severe, unstable, or uncontrolled comorbidities, including NYHA Class III/IV heart failure, unstable angina, or myocardial infarction within the past 6 months.
- Severe hepatic impairment (Child-Pugh Class C) or severe renal impairment (eGFR < 30 mL/min/1.73 m²).
- Active, severe psychiatric disorders (e.g., severe depression with active suicidal ideation, psychotic disorders, unstable bipolar disorder).
- Diagnosis of progressive neurodegenerative diseases (Parkinson's, Alzheimer's) or moderate-to-advanced dementia.
- Active, clinically significant inflammatory bowel disease (Crohn's disease, ulcerative colitis) or other severe gastrointestinal disorders.
- Evidence of gastrointestinal mucosal damage (ulceration, perforation, bleeding) within 7 days prior to the first product dose.
- Clinically significant immunosuppression, including chronic systemic corticosteroids, HIV infection with a CD4+ cell count < 200/µl, history of solid organ or hematopoietic stem cell transplantation.
- Active infection requiring antibiotics during the induction phase or anticipated antibiotic use during the first 7 days post-induction.
- Prior fecal microbiota transplantation (FMT) treatment for indications other than recurrent C. difficile infection.
- Significant dysphagia precluding safe capsule ingestion.
- Inadequate baseline laboratory parameters (such as blood counts and kidney function).
- Any medical condition or circumstance judged by the Principal Investigator to compromise participant safety or protocol adherence.
- Anticipated inability to comply with study procedures, such as missing scheduled follow-up visits, lacking reliable home freezer storage, or having a lifestyle/occupation that prevents proper cold-chain product handling or consistent attendance.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Research Study Evaluating the Efficacy and Safety of Multi-dose Fecal Microbiota Transplantation (FMT) in Capsule Form as an Intervention to Slow Down the Rate of Biological Aging.
The goal of this clinical trial is to evaluate if multi-dose fecal microbiota transplantation (FMT) capsules can safely and effectively slow down biological aging and reduce chronic low-grade inflammation in adults aged 45 to 80 with metabolic neglect.
The main questions it aims to answer are:
Read more
- Can oral FMT capsules significantly slow the biological pace of aging as measured by the DunedinPACE epigenetic clock?
- Can FMT successfully reduce chronic systemic inflammation (measured by markers such as suPAR, IL-6, and hs-CRP)?
Researchers will compare participants receiving the active product to those receiving a matching placebo to see if the microbiome intervention improves metabolic health and cognitive function via the gut-brain axis.
Participants will:
- Undergo a short-term preparation phase involving targeted antibiotics and standard bowel cleansing.
- Receive an 2 initial induction doses of active product (or placebo) followed by 5 regular booster cycles administered approximately every 4 weeks.
- Attend periodic clinical visits for physical examinations, blood draws, stool sample collection (at home), and cognitive testing using the CANTAB platform and MoCA scale.
- Maintain a participant diary to record adverse events (AE), product administration, stool sample collection, and dietary habits.
- Conditions
- Aging, Healthy, Aging and Cognitive Health, Inflammation, Metabolic Syndrome, Fecal Microbiota Transplantation (FMT), Longevity
- Being tested
- Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps), PLACEBO for Fecal microbiota delivery through oral capsules
- Keywords
- Fecal Microbiota Transplantation (FMT), Gut Microbiome, Biological Aging, DunedinPACE, Metabolic Neglect, Inflammaging, Longevity, Healthy Aging, Multi-dose FMT
- Medical subject headings
- Inflammation, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps)Procedure or surgery
Fecal microbiota transplantation (FMT) capsules administered in an initial induction phase followed by subsequent booster cycles. Frozen oral capsules containing full-spectrum human gut microbiota given as an initial induction (comprising a single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks.
PLACEBO for Fecal microbiota delivery through oral capsulesProcedure or surgery
Placebo Capsules (Comparator): Frozen oral capsules identical in appearance, packaging, and dosing schedule to the active product, containing pharmacologically inert substances. Administered as an initial induction phase (single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| MBiotix HBI Caps | Experimental | MBiotix HBI Caps (FMT capsules) + Preparation antibiotics (Neomycin and Metronidazole) + Standard bowel cleansing (Macrogols). Participants receive targeted preparation antibiotics followed by bowel cleansing, and then a multi-dose regimen of fecal microbiota transplantation (FMT) capsules (MBiotix HBI Caps) in an initial induction phase and subsequent booster cycles. Receives: Procedure: Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps) |
| Placebo | Placebo comparator | Placebo Capsules (matching MBiotix HBI Caps) + Antibiotics Placebo (matching two active antibiotics) + Standard bowel cleansing (Macrogols). Participants receive matching placebo treatments for both the preparation antibiotics and the oral capsules (MBiotix HBI placebo), along with the same standard bowel cleansing and multi-dose schedule (an initial induction phase and subsequent booster cycles). Receives: Procedure: PLACEBO for Fecal microbiota delivery through oral capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Clinical and Biological Response (Responder Rate)
The primary outcome is the proportion of participants categorized as "Responders" following multi-dose fecal microbiota transplantation (MBiotix HBI Caps) compared to placebo. A participant is classified as a Responder if they demonstrate objective physiological improvement from Baseline to Week 13 and/or Week 26, defined as meeting at least one of the following two pre-specified criteria:
- Epigenetic Deceleration: A reduction of at least 5% from baseline in the DunedinPACE biological pace-of-aging algorithm.
- Attenuation of Inflammaging: A reduction of at least 25% from baseline in at least one circulating systemic inflammatory marker from the predefined panel (provided the marker was significantly elevated at baseline per study inclusion criteria).
Results will be reported as the percentage of participants in each treatment arm meeting this composite response definition.
Measured: Baseline, Week 13, and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startDec 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aging, HealthyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Human Biome S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912164
- Sponsor's protocol ID
- 13/HBI/2026
- Acronym
- LONGEVIBIOME
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Research Study Evaluating the Efficacy and Safety of Multi-dose Fecal Microbiota Transplantation (FMT) in Capsule Form as an Intervention to Slow Down the Rate of Biological Aging.
- ClinicalTrials.gov ID
- NCT07912164
- Acronym / sponsor ID
- LONGEVIBIOME / 13/HBI/2026
- Conditions
- Aging, Healthy, Aging and Cognitive Health, Inflammation, Metabolic Syndrome, Fecal Microbiota Transplantation (FMT), Longevity
- Keywords
- Fecal Microbiota Transplantation (FMT), Gut Microbiome, Biological Aging, DunedinPACE, Metabolic Neglect, Inflammaging, Longevity, Healthy Aging, Multi-dose FMT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Human Biome S.A.Industry (pharma, biotech, devices)
- Study start
- Dec 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (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 clinical trial is to evaluate if multi-dose fecal microbiota transplantation (FMT) capsules can safely and effectively slow down biological aging and reduce chronic low-grade inflammation in adults aged 45 to 80 with metabolic neglect.
The main questions it aims to answer are:
- Can oral FMT capsules significantly slow the biological pace of aging as measured by the DunedinPACE epigenetic clock?
- Can FMT successfully reduce chronic systemic inflammation (measured by markers such as suPAR, IL-6, and hs-CRP)?
Researchers will compare participants receiving the active product to those receiving a matching placebo to see if the microbiome intervention improves metabolic health and cognitive function via the gut-brain axis.
Participants will:
- Undergo a short-term preparation phase involving targeted antibiotics and standard bowel cleansing.
- Receive an 2 initial induction doses of active product (or placebo) followed by 5 regular booster cycles administered approximately every 4 weeks.
- Attend periodic clinical visits for physical examinations, blood draws, stool sample collection (at home), and cognitive testing using the CANTAB platform and MoCA scale.
- Maintain a participant diary to record adverse events (AE), product administration, stool sample collection, and dietary habits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MBiotix HBI Caps | Experimental | Procedure: Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps)MBiotix HBI Caps (FMT capsules) + Preparation antibiotics (Neomycin and Metronidazole) + Standard bowel cleansing (Macrogols). Participants receive targeted preparation antibiotics followed by bowel cleansing, and then a multi-dose regimen of fecal microbiota transplantation (FMT) capsules (MBiotix HBI Caps) in an initial induction phase and subsequent booster cycles. |
| Placebo | Placebo comparator | Procedure: PLACEBO for Fecal microbiota delivery through oral capsulesPlacebo Capsules (matching MBiotix HBI Caps) + Antibiotics Placebo (matching two active antibiotics) + Standard bowel cleansing (Macrogols). Participants receive matching placebo treatments for both the preparation antibiotics and the oral capsules (MBiotix HBI placebo), along with the same standard bowel cleansing and multi-dose schedule (an initial induction phase and subsequent booster cycles). |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Voluntary written informed consent signed prior to any study-related procedures.
- Age between 45 and 80 years (inclusive) at the time of screening.
- Classified as "metabolically neglected" with documented pre-disease conditions or regulated early-stage chronic disorders.
- Accelerated biological aging rate 1.1, OR between 1.05 and 1.099 combined with chronic low-grade inflammation (inflammaging).
- Preserved cognitive function with a Montreal Cognitive Assessment (MoCA) score between 24 and 30 points.
Key exclusion criteria (22 listed)
- Systemic antibiotic therapy within 12 weeks prior to baseline.
- Supplementation with any commercial pre- or probiotics within 4 weeks prior to baseline.
- Diagnosed malignancy within the past 5 years (except fully cured basal cell carcinoma or cervical cancer in situ).
- Participation in any other clinical study or trial within 30 days prior to consent or during this study.
- Pregnancy, breastfeeding, or planning a pregnancy during the study and for 30 days post-intervention.
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 |
|---|---|---|
| Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps)Fecal microbiota transplantation (FMT) capsules administered in an initial induction phase followed by subsequent booster cycles. Frozen oral capsules containing full-spectrum human gut microbiota given as an initial induction (comprising a single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks. | Procedure or surgery | MBiotix HBI Caps |
| PLACEBO for Fecal microbiota delivery through oral capsulesPlacebo Capsules (Comparator): Frozen oral capsules identical in appearance, packaging, and dosing schedule to the active product, containing pharmacologically inert substances. Administered as an initial induction phase (single dose on Day 7 and split daily doses on Days 9-14) following preparation, followed by intermittent 6-day booster cycles administered approximately every 4 weeks | Procedure or surgery | Placebo |
Primary outcome
Percentage of Participants Achieving Clinical and Biological Response (Responder Rate)
Time frame: Baseline, Week 13, and Week 26
The primary outcome is the proportion of participants categorized as "Responders" following multi-dose fecal microbiota transplantation (MBiotix HBI Caps) compared to placebo. A participant is classified as a Responder if they demonstrate objective physiological improvement from Baseline to Week 13 and/or Week 26, defined as meeting at least one of the following two pre-specified criteria: * Epigenetic Deceleration: A reduction of at least 5% from baseline in the DunedinPACE biological pace-of-aging algorithm. * Attenuation of Inflammaging: A reduction of at least 25% from baseline in at least one circulating systemic inflammatory marker from the predefined panel (provided the marker was significantly elevated at baseline per study inclusion criteria). Results will be reported as the percentage of participants in each treatment arm meeting this composite response definition.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal microbiota transplantation delivery through oral capsules (HBI MBiotix Caps) in people with Aging, Healthy and Aging and Cognitive Health, run by Human Biome S.A..
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 12 inclusion and 22 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: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Percentage of Participants Achieving Clinical and Biological Response (Responder Rate) (time frame: Baseline, Week 13, and Week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Nov 2026.