Impact of Probiotics on Gut Microbiome During Antibiotic Prophylaxis in Elective Orthopedic Surgery

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Acibadem Maslak Hospital
Study ID
NCT06791993
Phase
PHASE4
Status
Not Yet Recruiting

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Conditions

  • Antibiotic Prophylaxis
  • Dysbiosis
  • Gut -microbiota
  • Microbiome Analysis
  • Probiotic

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Placebo Capsule — DRUG
    Participants will receive an inert placebo capsule that matches the probiotic capsule in size, shape, and color. The placebo will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.
  • Probiotic with Human Milk Oligosaccharides (HMO) — DIETARY_SUPPLEMENT
    Participants will receive a dual-strain probiotic containing Human Milk Oligosaccharides (HMO) in capsule form. The probiotic will be administered orally twice daily, starting 2 weeks before surgery and continuing for 2 weeks postoperatively.

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
Jan 2025
Primary completion
Aug 1, 2025
Completion
Oct 1, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Placebo Comparator: Routine Antibiotic Prophylaxis + Placebo
    This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a placebo capsule to match the probiotic intervention.
  • Experimental: Routine Antibiotic Prophylaxis + Probiotics
    This arm receives routine antibiotic prophylaxis with a single dose of intravenous Cefazolin and a dual-strain probiotic containing Human Milk Oligosaccharides (HMO).

Primary Outcome Measure

Maintenance of Gut Microbiome Balance [ Time Frame: 2 weeks preoperatively (T0) to 1 month postoperatively (T4). ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Parvizi Surgical InnovationPhiladelphiaPennsylvania19107
Emanuele Chisari, Dr., Ph.D
[email protected]
+1 646 806 8067
Emanuele Chisari, Dr., Ph.D

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By research site
Parvizi Surgical Innovation· Philadelphia, PA

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