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

NCT07423897 | Active Not Recruiting

• 1 other identifier: PS19
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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 pneumoniae without adverse effects.

Conditions

Gastrointestinal; Gut Health

Keywords

Gastrointestinal; Gut Health; GI; Probiotic

Outcome Measures

Primary Outcomes (1)

• 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.

  4 weeks

Secondary Outcomes (5)

• Gastrointestinal Symptoms

  6 weeks

• Daily Gastrointestinal Symptoms

  4 weeks

• Impact on Gut Microbiota

  6 weeks

• Safety of Probiotic (Blood Hematology Profile)

  4 weeks

• Safety of Probiotic (Blood Chemistry Profile)

  4 weeks

Study Arms (2)

Placebo Arm

PLACEBO COMPARATOR

Matching Placebo

Dietary Supplement: Placebo

Study Product Arm

ACTIVE COMPARATOR

Participants taking the Probiotic Supplement

Dietary Supplement: Bifidobacterium pseudocatenulatum

Interventions

Bifidobacterium pseudocatenulatum DIETARY_SUPPLEMENT

Probiotic Supplement

Study Product Arm

Placebo DIETARY_SUPPLEMENT

Matching placebo

Placebo Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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:
• 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:

Sponsors & Collaborators

• Synbiotic Health: lead
• People Science, Inc.: collaborator

Study Sites (1)

People Science, Inc.

Los Angeles, California, 90045, United States

Location

Study Officials

• Noah Craft, M.D., Ph.D.

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

• Azure Grant

  People Science, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2026
• First Posted: February 20, 2026
• Study Start: February 2, 2026
• Primary Completion: June 17, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

US (1)