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

NCT06791993 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-01-24

No results posted yet for this study

Summary

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.

Conditions

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

Interventions

DRUG

Placebo Capsule

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.

DIETARY_SUPPLEMENT

Probiotic with Human Milk Oligosaccharides (HMO)

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.

Sponsors & Collaborators

  • Acibadem University

    collaborator OTHER

  • Acibadem Maslak Hospital

    lead OTHER

Principal Investigators

  • Javad Parvizi, Prof. Dr. · International Joint Center Acibadem, Parvizi Surgical Innovation

  • Emanuele Chisari, Dr., Ph.D. · Parvizi Surgical Innovation, University of Groningen

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-01
Primary Completion
2025-08-01
Completion
2025-10-01
FDA Drug
Yes

Countries

  • United States
  • Thailand
  • Turkey (Türkiye)

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06791993 on ClinicalTrials.gov