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SURGIcal COmplication and MIcrobiome ChangeS in Colorectal Surgery

NCT05779254 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-03-22

No results posted yet for this study

Summary

The microbiome, the collection of microorganisms that live in our gut, plays an important role in maintaining our health, proper nutrient absorption, nutrient turnover and immunity. After birth, a symbiotic relationship develops with the strains of bacteria that colonise our gut, and the presence and proportion of bacteria is individualised and highly variable.

A healthy bacterial flora is essential for the cells of the intestinal mucosa. Glycoproteins in the cell surface mucus coat are important nutrients for bacteria, while some bacterial strains supply mucosal cells with nutrient molecules (e.g. short-chain fatty acids) that are their essential energy source.

An abnormal change in the proportion of bacterial strains that make up the microbiome, dysbacteriosis, in which pathogenic bacteria proliferate at the expense of members of the normal flora, can cause a number of pathologies. Nutrient supply to the cells of the mucosa is reduced, making them more vulnerable and leading to various pathological conditions.

The microbiome and the essential nutrients they produce have also been found to play an important role in wound healing. A decrease in the diversity of the microbiome, an increase in the relative number of pathogenic bacteria and a decrease in the proportion of 'beneficial' bacteria increases the risk of surgical complications of infection and suture failure.

Conditions

  • Anastomotic Leak
  • Microbial Colonization

Interventions

DRUG

Neomycin Sulfate

Postoperative day-1 Oral Antibiotic Prophylaxis + patients get po. 3x1000mg Neomycin sulfate and 3x500 mg Metronidazole

Sponsors & Collaborators

  • University of Debrecen

    collaborator OTHER

  • Csolnoky Ferenc Hospital

    collaborator UNKNOWN

  • Uzsoki Hospital

    lead OTHER

Principal Investigators

  • Peter Bay, Prof. · University of Debrecen

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-01-31
Completion
2026-01-31

Countries

  • Hungary

Study Locations

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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 NCT05779254 on ClinicalTrials.gov