Probiotics in the Prevention of Complications After Colorectal Surgery

NCT02313519 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 164

Last updated 2014-12-10

No results posted yet for this study

Summary

Based on the need of large-scale, trials to explore the use of probiotics to reduce post-operative complication rate, a randomized controlled trial is designed to investigate the impact of a probiotics treatment protocol on postoperative morbidity in an open elective colonic surgery cohort. The major objective is reduction of post-operative complications after 30 days.

Conditions

  • Postoperative Complications

Interventions

DIETARY_SUPPLEMENT

Probiotics

Probiotics are prepared in capsule form

DIETARY_SUPPLEMENT

Placebo

Glucose powder

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    collaborator OTHER
  • Evangelos J. Giamarellos-Bourboulis, M.D.

    lead OTHER

Principal Investigators

  • Katerina Kotxampassi, MD, PhD · AXEPA University of Thessaloniki, 1st Department of Propedeutic Surgery, Thessaloniki, Greece

  • Evangelos Giamarellos-Bourboulis, MD, PhD · University of Athens, 4th Department of Internal Medicine, Athens, Greece

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2014-07-31
Completion
2014-08-31

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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 NCT02313519 on ClinicalTrials.gov