Probiotics for Gut Microbiome Imbalance
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether probiotics can help maintain gut health for individuals undergoing certain orthopedic surgeries. Antibiotics used to prevent infections during surgery can disrupt gut bacteria balance. Researchers aim to determine if adding probiotics, specifically those with Human Milk Oligosaccharides, can preserve this balance. The study includes two groups: one receives probiotics with their antibiotics, while the other receives a placebo (a pill with no active ingredients). Suitable candidates for this trial are adults undergoing low-risk surgeries, such as knee arthroscopy, who have not recently used antibiotics or probiotics. As a Phase 4 trial, this research seeks to understand how the already FDA-approved treatment benefits a broader range of patients.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you've used antibiotics, probiotics, vitamins, or herbal supplements recently. It's best to discuss your specific medications with the trial team.
What is the safety track record for this treatment?
A previous study found probiotics and human milk oligosaccharides (HMOs) to be safe and easy for people to handle. When combined, probiotics and HMOs did not cause any serious side effects. Research has shown that these supplements help create a healthy gut, which is important for digestion and overall health.
Another study found that a probiotic formula with HMOs was well-accepted by infants, supporting their growth and possibly improving their gut health. These findings suggest that using probiotics and HMOs together is generally safe for people.
This treatment is still under study, so joining a clinical trial can contribute to understanding its safety and benefits.12345Why are researchers enthusiastic about this study treatment?
Most treatments for gut microbiome imbalance typically involve antibiotics or standard probiotics. However, this new treatment is unique because it combines probiotics with Human Milk Oligosaccharides (HMO), a component found in human breast milk, believed to support beneficial gut bacteria more effectively. Researchers are excited because HMOs could enhance the probiotic's ability to restore gut balance and potentially improve gut health faster and more sustainably than current options. This combination could offer a more targeted approach to nurturing a healthy gut environment.
What evidence suggests that probiotics might be an effective treatment for gut microbiome imbalance?
This trial will evaluate the effects of probiotics with Human Milk Oligosaccharides (HMOs) on gut health. Participants in one arm of the trial will receive routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing HMOs. Research has shown that probiotics with HMOs can maintain gut health by promoting the growth of beneficial bacteria. Studies also suggest they might reduce inflammation and boost the immune system. Specifically, the probiotic strain B. infantis M-63 works effectively with HMOs to support gut health. This combination may help manage gut issues caused by antibiotics, keeping the gut balanced and healthy.13467
Who Is on the Research Team?
Javad Parvizi, Prof. Dr.
Principal Investigator
International Joint Center Acibadem, Parvizi Surgical Innovation
Emanuele Chisari, Dr., Ph.D.
Principal Investigator
Parvizi Surgical Innovation, University of Groningen
Are You a Good Fit for This Trial?
This trial is for patients undergoing elective orthopedic surgery who will receive antibiotics to prevent infection. It's designed to see if probiotics can keep their gut bacteria balanced during treatment. People with conditions that might affect the study or those on other treatments affecting gut health are not eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Preoperative
Participants receive routine antibiotic prophylaxis and either probiotics or placebo 2 weeks before surgery
Perioperative
Participants undergo elective orthopedic surgery with continued administration of antibiotics and probiotics/placebo
Postoperative
Participants continue receiving probiotics/placebo and are monitored for gut microbiome balance and overall well-being
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Probiotic with Human Milk Oligosaccharides (HMO)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Acibadem Maslak Hospital
Lead Sponsor
Acibadem University
Collaborator