Consumer Health Study Aims to Evaluate the Safety, Tolerability and Impact of ED02 Probiotic Supplement on Gastrointestinal Outcomes

March 31, 2026 updated by: Synbiotic Health

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90045
        • People Science, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.
  • 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.

Exclusion Criteria:

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:

    1. Participants receiving any investigational therapies or treatments within 30 days prior to randomization.
    2. Participants currently taking or have taken antibiotics, probiotic, or prebiotic supplements within the past 4 weeks prior to randomization.
    3. Participants using immunomodulating supplements, immunosuppressive medications, systemic steroids, antifungals or other medications known to significantly impact gastrointestinal function or microbiota.
    4. Participants currently taking fiber supplements
    5. Participants currently taking laxatives
    6. Participants taking chronic NSAIDs
    7. Participants taking Metformin

  • Other Illnesses or Conditions: Participants who have the following comorbidities or gastrointestinal illnesses are excluded:

    1. 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)

    2. Participants with a known or suspected gastrointestinal infection, such as:

      • Clostridium difficile infection
      • Helicobacter pylori infection
      • Parasitic infections (e.g., Giardia, Cryptosporidium)
    3. Participants with a history of gastrointestinal bleeding or perforation.

    4. Participants with autoimmune conditions, such as:

      • Lupus
      • Multiple sclerosis
      • Rheumatoid Arthritis
    5. Participants with an immunocompromised status.
    6. Participants with uncontrolled diabetes.
    7. Participants with a history of gastrointestinal surgery, excluding appendectomy and cholecystectomy.
    8. Currently diagnosed with Alcohol Use Disorder and/or Substance Use Disorder.
    9. Currently pregnant, planning to become pregnant in the next 3 months, or breastfeeding.
    10. Any underlying medical conditions or comorbidities that may confound the assessment of digestive symptoms or the evaluation of the study outcomes.
    11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Arm
Matching Placebo
Dietary supplement: Placebo
Matching placebo
Active Comparator: Study Product Arm
Participants taking the Probiotic Supplement
Dietary supplement: Bifidobacterium pseudocatenulatum
Probiotic Supplement

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Gastrointestinal Symptoms
Time Frame: 6 weeks
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.
6 weeks
Daily Gastrointestinal Symptoms
Time Frame: 4 weeks
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.
4 weeks
Impact on Gut Microbiota
Time Frame: 6 weeks
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.
6 weeks
Safety of Probiotic (Blood Hematology Profile)
Time Frame: 4 weeks
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).
4 weeks
Safety of Probiotic (Blood Chemistry Profile)
Time Frame: 4 weeks
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).
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Synbiotic Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
People Science, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noah Craft, M.D., Ph.D., People Science, Inc.
  • Principal Investigator: Azure Grant, People Science, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 17, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 1, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PS19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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