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

Running, not enrolling · Not applicable · Has a placebo group

Conditions studied: Gastrointestinal, Gut Health

In brief

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.

Key facts

Study ID

NCT07423897

Run by

Synbiotic Health

People needed

35

Starts

2026-02-02

Expected to finish

2026-08-31

Last updated by the study team

2026-04-01

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

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:
• 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)

Where it is running

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

Full record on ClinicalTrials.gov

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