ED02 Probiotic for Gut Health

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Synbiotic Health
Must be taking: Anxiety medications

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the probiotic Bifidobacterium pseudocatenulatum ED02 can improve gut health and combat harmful infections, such as those caused by Klebsiella pneumoniae. Participants will take either this probiotic or a placebo to assess its impact on their digestive system without negative side effects. It suits individuals interested in understanding their gut health who are stable on medications for anxiety or regularly use cannabis or nicotine. Participants should not follow special diets like carnivore or liquid diets and must be willing to provide stool samples. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in gut health.

Do I need to stop taking my current medications for the trial?

You don't need to stop your current medications, but if you're taking anxiety medications, cannabis, or nicotine products, you must be on a stable dose for at least 4 weeks before and during the study. You cannot take antibiotics, probiotics, prebiotics, immunosuppressive medications, or certain other medications that affect gut health.

Is there any evidence suggesting that Bifidobacterium pseudocatenulatum ED02 is safe?

Research has shown that Bifidobacterium pseudocatenulatum ED02 is a safe and effective probiotic. This strain originates from a healthy human and lacks harmful genes. Studies indicate it can combat infections from harmful bacteria like Klebsiella pneumoniae without causing adverse effects. Available data do not report any side effects linked to this probiotic, suggesting it is well-tolerated in humans.12345

Why are researchers excited about this trial?

Unlike other treatments for gut health that often rely on dietary changes or medications to address symptoms, Bifidobacterium pseudocatenulatum ED02 is a probiotic supplement that introduces beneficial bacteria directly into the gut. Researchers are excited about this treatment because it offers a novel approach by potentially restoring the natural balance of gut flora. This could lead to improved digestion and overall gut health without the side effects commonly associated with traditional medications.

What evidence suggests that Bifidobacterium pseudocatenulatum ED02 might be an effective treatment for gut health?

Research shows that Bifidobacterium pseudocatenulatum ED02 is a promising probiotic. Studies have found it to be safe and effective, protecting the gut from infections without causing harm. This trial will evaluate Bifidobacterium pseudocatenulatum ED02, administered to participants in the study product arm, to determine if it reduces inflammation and improves gut health by increasing beneficial bacteria in the digestive system. Additionally, B. pseudocatenulatum has been linked to better recovery of the gut's natural balance after diarrhea. While these findings are encouraging, they should be viewed as part of ongoing research.12367

Who Is on the Research Team?

NC

Noah Craft, M.D., Ph.D.

Principal Investigator

People Science, Inc.

AG

Azure Grant

Principal Investigator

People Science, Inc.

Are You a Good Fit for This Trial?

This trial is for adults (18+) in good general health, living in the US, interested in gut health, able to use a smartphone app, and willing to avoid probiotics/prebiotics during the study. People with recent antibiotic or probiotic use, GI illnesses, certain medical conditions or medications, pregnancy/breastfeeding cannot join.

Inclusion Criteria

Willing to practice a reliable method of contraception for the duration of the study
I have been on the same dose of anxiety medication for at least 4 weeks.
Willingness to refrain from taking probiotics or prebiotics during the study period
See 10 more

Exclusion Criteria

Do not have a personal smartphone, internet access, or unwilling to download Chloe
I have used antibiotics, probiotics, or prebiotics in the past 4 weeks.
I am taking medications or supplements that affect my immune system or gut health.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the probiotic supplement or placebo to evaluate impact and tolerability

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of gastrointestinal symptoms and gut microbiota

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Bifidobacterium pseudocatenulatum ED02

Trial Overview

The study compares a probiotic supplement containing Bifidobacterium pseudocatenulatum ED02 against a placebo to see how safe and well-tolerated it is and its effects on gut health. Participants are randomly assigned to either group.

How Is the Trial Designed?

2

Treatment groups

Active Control

Placebo Group

Group I: Study Product ArmActive Control1 Intervention
Group II: Placebo ArmPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Synbiotic Health

Lead Sponsor

People Science, Inc.

Industry Sponsor

Trials
7
Recruited
730+

Citations

Consumer Health Study Aims to Evaluate the Safety ...

The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor.

ED02 Probiotic for Gut Health · Info for Participants

The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human ...

Consumer Health Study Aims to Evaluate the Safety ...

The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor.

4.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/30251018/

Bifidobacterium pseudocatenulatum CECT 7765 ...

B. pseudocatenulatum CECT 7765 intake together with dietary recommendations can improve inflammatory status in children with obesity and insulin resistance.

Consumer Health Study Aims to Evaluate the Safety, ...

The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor. Research by the ...

Role of Bifidobacterium pseudocatenulatum in Degradation ...

The results described here provide biochemical and genetic evidence for primary xylan utilization by human-derived Bifidobacterium pseudocatenulatum.

NCT07423897 | Clinical Trial | Drug Landscape

The Study Team identified Bifidobacterium pseudocatenulatum ED02 as a safe and effective probiotic strain isolated from a healthy human donor.