ED02 Probiotic for Gut Health
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?
Noah Craft, M.D., Ph.D.
Principal Investigator
People Science, Inc.
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the probiotic supplement or placebo to evaluate impact and tolerability
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of gastrointestinal symptoms and gut microbiota
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
Participants taking the Probiotic Supplement
Matching Placebo
Find a Clinic Near You
Who Is Running the Clinical Trial?
Synbiotic Health
Lead Sponsor
People Science, Inc.
Industry Sponsor
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.
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.
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