Bacteriophages for Gut Health
(Phage-CLEAR Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to test the effectiveness of two bacteriophage treatments, MuniPhage and RenuPhage, in improving gut and skin health. Bacteriophages are tiny viruses that attack specific bacteria in the body. The trial targets certain strains of E. coli and Staphylococcus aureus that may cause digestive issues and skin problems. It suits individuals aged 18 to 75 who frequently experience mild to moderate digestive troubles, such as bloating, constipation, or diarrhea. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research on innovative treatments for common health issues.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that bacteriophages, such as those in MuniPhage and RenuPhage, are generally safe for people. One study found that these phages are well-tolerated and target harmful bacteria in the gut, promoting the growth of beneficial bacteria. Another study noted that some patients using phage therapy experienced side effects, but most were not serious.
For RenuPhage, research suggests that a mix of four bacteriophages is safe and tolerable. These phages specifically attack certain harmful bacteria, leaving human cells and beneficial bacteria unharmed. This reduces the risk of side effects like drug toxicity, which can occur with some medications.
Overall, current research indicates that both MuniPhage and RenuPhage are safe treatments.12345Why are researchers excited about this trial's treatments?
Unlike the standard treatments for gut-related issues, which often involve antibiotics or probiotics, MuniPhage and RenuPhage utilize bacteriophages, which are viruses that specifically target and destroy harmful bacteria. MuniPhage is designed to target specific pro-inflammatory E. coli strains, while RenuPhage focuses on reducing Staphylococcus aureus in the gut and potentially on the skin. This targeted approach offers a precision that antibiotics lack, potentially minimizing side effects and preserving beneficial bacteria. Researchers are excited because these treatments promise a novel mechanism of action that could revolutionize gut health management by directly targeting harmful bacteria without disturbing the overall microbiome balance.
What evidence suggests that this trial's treatments could be effective for gut and skin health?
Research has shown that bacteriophages, like those in MuniPhage, can restore gut balance by targeting harmful bacteria, such as certain types of E. coli. Studies have found that these phages reduce inflammation and improve gut health by specifically targeting and reducing harmful bacteria. In this trial, participants may receive MuniPhage, designed for this purpose.
RenuPhage, another treatment option in this trial, targets Staphylococcus aureus in the gut, which might also alleviate skin problems linked to these bacteria. This method works because bacteriophages selectively infect and kill specific bacteria, potentially improving gut and skin health. Both treatments aim to create a healthier balance of bacteria in the gut, which may benefit overall health.678910Who Is on the Research Team?
Tiffany Weir, PhD
Principal Investigator
Colorado State University
Are You a Good Fit for This Trial?
This trial is for adults with gut or skin issues who want to improve their gastrointestinal symptoms or skin quality. People with serious health conditions, recent antibiotic use, or allergies to study ingredients may not be able to join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive bacteriophage-based treatments targeting specific strains of Escherichia coli and Staphylococcus Aureus for gut and skin health improvement
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- MuniPhage
- RenuPhage
Trial Overview
The study tests two types of bacteriophage treatments—MuniPhage and RenuPhage—that target specific bacteria in the gut and on the skin. Participants will take these treatments or a placebo daily for 4 weeks to see if they help gut and skin health.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Dietary supplement containing 1 x 10E6 PFU of phage strains LG91, BD117, CD007, and PD23 designed to target S. aureus in the gut which may also reduce S. aureus load on the skin.
1 x 10E6 Plaque Forming Units (PFU) of bacteriophage strains PBH34, CAH57, BFX121, and DNK95 that have been designed to target specific pro-inflammatory E. coli strains in the gut.
Rice maltodextrin
Find a Clinic Near You
Who Is Running the Clinical Trial?
Colorado State University
Lead Sponsor
Citations
1.
springermedizin.de
springermedizin.de/bacteriophages-in-the-gastrointestinal-tract-and-their-implicati/13943044Bacteriophages in the gastrointestinal tract and their ...
Furthermore, recent data suggest that phages may mediate the beneficial effects of fecal microbiota transplantation (FMT). Therefore, evidence is accumulating ...
2.
enviromedica.com
enviromedica.com/blogs/learn/bacteriophages-and-the-human-microbiome?srsltid=AU7gw4XheTJYp4f-TUSSWRUU75lJsNkHkFpCvTIDW5CopcrM0T-OV8CMCan Bacteriophages Improve Gut Health?
Bacteriophages may help restore balance in the human gut microbiome caused by pathogenic microbes. ➡️ Learn more! 60 capsules / 30 servings $59.95
PHAGE Study: Bacteriophages as Novel Prebiotics
The goal of this study is to see if PreforPro consumption improves gut bacteria profiles in individuals relative to a placebo control and is ...
Evaluation of bacteriophages as a signature of microbiome ...
We aimed to test whether viromes can be used as broad signatures of microbiome health using previously published results across systems. Of the 69 studies that ...
5.
nutraingredients.com
nutraingredients.com/Article/2022/08/04/Phage-combination-may-boost-gut-health-by-precisely-targeting-IBD-related-bugs/Phage combination may boost gut health by precisely ...
New data published in the journal Cell now showcases the possibility of using phages for modulating the gut microbiome to improve health.
6.
researchgate.net
researchgate.net/publication/374419032_The_Role_of_Bacteriophages_in_the_Gut_Microbiota_Implications_for_Human_HealthThe Role of Bacteriophages in the Gut Microbiota
Bacteriophages (phages) are nano-sized viruses characterized by their inherent ability to live off bacteria. They utilize diverse mechanisms ...
a cautionary tale for evaluation of bacteriophage therapy ...
Endemic bacteriophages: a cautionary tale for evaluation of bacteriophage therapy and other interventions for infection control in animals.
Study Details | NCT04650607 | Phage Safety Cohort Study
Inclusion Criteria: Patient 18 years of age or older with a serious infection treated at CRIOAc Lyon by phage therapy; Patient who did not object to ...
Phage treatment of multidrug-resistant bacterial infections ...
This review describes clinical cases and preclinical studies in which phage therapy has been effective in both human and veterinary medicine, ...
Trial | NCT03269617
These phages are generally regarded as safe for human consumption and work by infecting bad bacteria in the gut, which allows beneficial bacteria populations to ...
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