Probiotics for Gut Microbiome Imbalance

Recruiting in Palo Alto (17 mi)

+5 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Acibadem Maslak Hospital

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study aims to evaluate whether probiotics can help maintain a healthy gut microbiome in patients receiving prophylactic antibiotics during elective orthopedic surgery. Antibiotics, while effective in preventing infections, can disrupt the balance of gut bacteria, leading to dysbiosis. The study hypothesizes that the use of probiotics during the perioperative period can prevent or reduce this disruption, supporting gut health and overall well-being. The research seeks to answer whether combining probiotics with routine antibiotic prophylaxis can preserve gut microbiome balance and improve patient outcomes.

Eligibility Criteria

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

I am between 18 and 65 years old.

I am scheduled for a minor orthopedic surgery.

Exclusion Criteria

Known allergy to beta-lactam or cephalosporin antibiotics

I have used probiotics, vitamins, or herbal supplements in the last 4 weeks.

I have an autoimmune or chronic inflammatory condition.

+3 more

Participant Groups

The study tests whether a probiotic capsule containing Human Milk Oligosaccharides (HMO) can protect the gut microbiome from disruption typically caused by antibiotics given during surgery, compared to a placebo.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Routine Antibiotic Prophylaxis + ProbioticsExperimental Treatment1 Intervention

This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).

Group II: Routine Antibiotic Prophylaxis + PlaceboPlacebo Group1 Intervention

This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.