GastrointestinalNCT07423897
Consumer Health Study Aims to Evaluate the Safety, Tolerability and Impact of ED02 Probiotic Supplement on Gastrointestinal Outcomes
A study testing Bifidobacterium pseudocatenulatum in people with Gastrointestinal and Gut Health, run by Synbiotic Health at 1 site in United States.
Trial summary
The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal, Gut Health
- What is being tested?
- Bifidobacterium pseudocatenulatum
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Feb 2026to 3 Aug 2026
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years and older, inclusive.
- Willingness to refrain from taking probiotics or prebiotics during the study period.
- Interested in understanding more about their gut health and the use of probiotic products.
- If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
- If using any cannabis-containing products, must be on a stable dose regimen for at least 4 weeks prior to randomization and throughout the course of the study.
- If using any nicotine-containing products, must be on a stable regimen for at least 4 weeks prior to randomization and throughout the course of the study.
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- Willing to practice a reliable method of contraception for the duration of the study.
- In good general health at the time of screening (Investigator discretion).
- Able to read and understand English.
- Able to read, understand, and provide informed consent.
- Able to use a personal smartphone device and download Chloe by People Science.
- Able to receive shipment of the product at an address within the United States.
- Able to complete study assessments over the course of up to 15 weeks.
Who cannot join
- Any potential participants who:
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
- Plan to make major changes in their diet during the study period.
- Are not willing to complete stool samples.
- Concomitant Therapies:
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- Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
- Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
- Participants using immunomodulating supplements, immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
- Participants currently taking fiber supplements
- Participants currently taking laxatives
- Participants taking chronic NSAIDs
- Participants taking Metformin
- Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:
- Participants with a clinical diagnosis of any gastrointestinal illness, including but not limited to:
- Inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)
- Gastroesophageal reflux disease (GERD)
- Gastric or duodenal ulcers
- Celiac disease
- Diverticular disease
- Chronic pancreatitis
- Gastroparesis
- Severe liver disease (e.g., cirrhosis, hepatitis, NAFLD acceptable)
- Gallbladder disease (e.g., cholecystitis, cholelithiasis)
- Gastrointestinal cancer (Colorectal, Intestinal, Stomach, Liver, Gallbladder)
- Participants with a known or suspected gastrointestinal infection, such as:
- Clostridium difficile infection
- Helicobacter pylori infection
- Parasitic infections (e.g., Giardia, Cryptosporidium)
- Participants with a history of gastrointestinal bleeding or perforation.
- Participants with autoimmune conditions, such as:
- Lupus
- Multiple sclerosis
- Rheumatoid Arthritis
- Participants with an immunocompromised status.
- Participants with uncontrolled diabetes.
- Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
- Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
- Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
- Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
- Have a significant illness, disease or condition which, in the opinion of the principal investigator, may impact their ability to participate in the study or impact the study outcomes.
- Known hypersensitivity or previous allergic reaction to microcrystalline cellulose, magnesium stearate, or silicon dioxide.
- Are unlikely for any reason to be able to comply with the trial or considered unsuited for participation in the study by the Principal Investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Pilot Study Evaluating the Safety, Tolerability and Impact of Synbiotic Health's Bifidobacterium Pseudocatenulatum ED02 Probiotic Supplement on Gastrointestinal Outcomes
The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella pneumoniae without adverse effects.
Read the detailed description
Species within the genus Bifidobacterium are vital components of the human microbiome across all life stages, with B. pseudocatenulatum being a primary species found in adults. The Study Team highlighted that the specific strain ED02 was isolated from the fecal matter of a healthy adult after being enriched with the prebiotic xylooligosaccharides. To ensure the strain's safety for therapeutic use, the Study Team performed genome sequencing, which confirmed the absence of any virulence factors or antibiotic resistance genes. Furthermore, in vivo testing conducted by the Study Team demonstrated that ED02 provided significant health improvements in mice infected with hypervirulent Klebsiella pneumoniae. Throughout these trials, the Study Team observed no adverse events, supporting the potential of ED02 as a safe intervention for gastrointestinal and systemic health.
- Conditions
- Gastrointestinal, Gut Health
- Being tested
- Bifidobacterium pseudocatenulatum, Placebo
- Keywords
- Gastrointestinal, Gut Health, GI, Probiotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium pseudocatenulatumDietary supplement
Probiotic Supplement
PlaceboDietary supplement
Matching placebo
| Study group | Role | What they receive |
|---|---|---|
| Placebo Arm | Placebo comparator | Matching Placebo Receives: Dietary Supplement: Placebo |
| Study Product Arm | Active comparator | Participants taking the Probiotic Supplement Receives: Dietary Supplement: Bifidobacterium pseudocatenulatum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact and Tolerability
The primary objective of the study is to evaluate the impact and tolerability of the probiotic study product. This is measured by assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.
Measured: 4 weeks
Secondary outcomes (5)
Gastrointestinal Symptoms
To evaluate the impact of the probiotic study product on gastrointestinal symptom rating. This will be measured by using changes in mean Gastrointestinal Symptom Rating Scale (GSRS) scores between placebo and study product groups during the study period.
Measured: 6 weeks
Daily Gastrointestinal Symptoms
The goal is to evaluate the impact of the probiotic study product on daily gastrointestinal symptoms by using the changes in average scores of gastrointestinal symptoms (i.e. flatulence, bloating, abdominal discomfort) between placebo and study product group as measured by daily survey questions.
Measured: 4 weeks
Impact on Gut Microbiota
To evaluate the impact of the probiotic study product on gut microbiota composition, diversity, and function assessed using metagenomic sequencing of fecal samples by using the changes from baseline to end treatment at Week 4 between study product and placebo group. Sample obtained at 2 weeks after the last dose will be compared as well.
Measured: 6 weeks
Safety of Probiotic (Blood Hematology Profile)
To evaluate the impact of the probiotic on safety by using changes in blood parameters from baseline to end of treatment between placebo and probiotic study groups. Blood biomarkers assessed by Complete Blood Count (CBC).
Measured: 4 weeks
Safety of Probiotic (Blood Chemistry Profile)
To evaluate the impact of the probiotic on safety by using changes in blood biomarkers from baseline to end of treatment between placebo and probiotic study groups. Blood biomarkers assessed by Comprehensive Metabolic Panel (CMP).
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start2 Feb 2026
- Primary completion28 Jul 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastrointestinalStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Synbiotic Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Responsible party
- Sponsor
- Investigators
- Noah Craft, M.D., Ph.D., Principal investigator, People Science, Inc.Azure Grant, Principal investigator, People Science, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423897
- Sponsor's protocol ID
- PS19
- Status last verified
- Oct 2026
- First submitted
- 5 Feb 2026
- Last updated
- 19 Oct 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Pilot Study Evaluating the Safety, Tolerability and Impact of Synbiotic Health's Bifidobacterium Pseudocatenulatum ED02 Probiotic Supplement on Gastrointestinal Outcomes
- ClinicalTrials.gov ID
- NCT07423897
- Acronym / sponsor ID
- PS19
- Conditions
- Gastrointestinal, Gut Health
- Keywords
- Gastrointestinal, Gut Health, GI, Probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Synbiotic HealthIndustry (pharma, biotech, devices)
- Collaborators
- People Science, Inc.
- Study start
- 2 Feb 2026 (actual)
- Primary completion
- 28 Jul 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 20 Feb 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 Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the Study Team indicates that this strain lacks harmful genetic traits and can successfully mitigate infections from hypervirulent pathogens like Klebsiella pneumoniae without adverse effects.
Detailed description
Species within the genus Bifidobacterium are vital components of the human microbiome across all life stages, with B. pseudocatenulatum being a primary species found in adults. The Study Team highlighted that the specific strain ED02 was isolated from the fecal matter of a healthy adult after being enriched with the prebiotic xylooligosaccharides. To ensure the strain's safety for therapeutic use, the Study Team performed genome sequencing, which confirmed the absence of any virulence factors or antibiotic resistance genes. Furthermore, in vivo testing conducted by the Study Team demonstrated that ED02 provided significant health improvements in mice infected with hypervirulent Klebsiella pneumoniae. Throughout these trials, the Study Team observed no adverse events, supporting the potential of ED02 as a safe intervention for gastrointestinal and systemic health.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Arm | Placebo comparator | Dietary Supplement: PlaceboMatching Placebo |
| Study Product Arm | Active comparator | Dietary Supplement: Bifidobacterium pseudocatenulatumParticipants taking the Probiotic Supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age 18 years and older, inclusive.
- Willingness to refrain from taking probiotics or prebiotics during the study period.
- Interested in understanding more about their gut health and the use of probiotic products.
- If taking any OTC or prescription medications for anxiety (e.g. magnesium, anticholinergics, Buspirone, Tricyclics, MAOIs,) or other class of medication for anxiety, must be on a stable dose for at least 4 weeks prior to randomization and throughout the course of the study.
- If using any cannabis-containing products, must be on a stable dose regimen for at least 4 weeks prior to randomization and throughout the course of the study.
Key exclusion criteria (43 listed)
- Do not have a personal smartphone, internet access, or unwilling to download Chloe.
- Currently on a carnivore diet, raw food diet, fruitarian, liquid diet (does not include vegans or vegetarians).
- Plan to make major changes in their diet during the study period.
- Are not willing to complete stool samples.
- Concomitant Therapies:
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 |
|---|---|---|
| Bifidobacterium pseudocatenulatumProbiotic Supplement | Dietary supplement | Study Product Arm |
| PlaceboMatching placebo | Dietary supplement | Placebo Arm |
Primary outcome
Impact and Tolerability
Time frame: 4 weeks
The primary objective of the study is to evaluate the impact and tolerability of the probiotic study product. This is measured by assessment of the number, frequency, and severity of adverse events (AEs), serious adverse events (SAEs) and AE withdrawals reported over the study product/placebo use period.
5 secondary outcomes
Gastrointestinal Symptoms
Time frame: 6 weeks
Daily Gastrointestinal Symptoms
Time frame: 4 weeks
Impact on Gut Microbiota
Time frame: 6 weeks
Safety of Probiotic (Blood Hematology Profile)
Time frame: 4 weeks
Safety of Probiotic (Blood Chemistry Profile)
Time frame: 4 weeks
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 19 Oct 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. This study is not recruiting at the moment.
Noah Craft, M.D., Ph.D. principal investigator
People Science, Inc.
Azure Grant principal investigator
People Science, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium pseudocatenulatum in people with Gastrointestinal and Gut Health, run by Synbiotic Health at 1 site in United States.
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 13 inclusion and 43 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 19 Oct 2026. 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 United States. 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. 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?
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?
Impact and Tolerability (time frame: 4 weeks). 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 19 Oct 2026.