Probiotics in the Prevention of Complications After Colorectal Surgery

NCT02313519 | Completed Phase 4 DMC

• 1 other identifier: LACT002
• Study Type: interventional
• Target: 164
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Infections; anastomotic leakage

Outcome Measures

Primary Outcomes (1)

• Postoperative complications

  The total of postoperative complications observes in each study group. These comprise: any anastomotic leakage; abdominal wound infection and dehiscence; organ specific infections, such as pneumonia, urinary tract and central vein port-site infections, and systemic infections \[bacteraemia, fungal infections\] as regularly defined by positive cultures, radiograms, increased white blood cell count or purulent material discharge; sepsis and septic shock

  30 days

Secondary Outcomes (3)

• Minor complications

  30 days

• Cytokine levels

  4 days

• Cytokine gene transcripts

  4 days

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Capsules of powdered glucose polymer given one capsule every 12 hours for 15 days

Dietary Supplement: Placebo

Probiotics

ACTIVE COMPARATOR

Capsules containing Lactobacillus acidophilus LA-5 \[1.75x10\^9 cfu\], Lactobacillus plantarum \[0.5x10\^9 cfu\], Bifidobacterium lactis BB-12 \[1.75x10\^9cfu\], and Saccharomyces boulardii \[1.5x10\^9\] per capsule. One capsule is given every 12 hours for 15 days

Dietary Supplement: Probiotics

Interventions

Probiotics DIETARY_SUPPLEMENT

Probiotics are prepared in capsule form

Also known as: Lactobacillus, Bifidobacterium and Saccharomyces boulardii

Probiotics

Placebo DIETARY_SUPPLEMENT

Glucose powder

Also known as: Placebo capsules

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Acceptable nutritional status and programmed for open surgery for colorectal cancer.
• Operation by the same consultant either as surgeon or as the primary assistant.

You may not qualify if:

• Inability to provide written informed consent
• The need only for emergency or palliative surgery
• American Society of Anaesthesiologists (ASA) class of IV
• Pregnancy or lactation
• Inflammatory bowel disease
• Use of antibiotics during the last 10 days before surgery
• Recent steroid therapy or preoperative neoadjuvant chemotherapy or radiotherapy
• Pre-existing signs of bacterial \[white cell count, body temperature\] or viral infection \[hepatitis B or C, human immunodeficiency virus, cytomegalovirus\].

Sponsors & Collaborators

• Evangelos J. Giamarellos-Bourboulis, M.D.: lead
• Aristotle University Of Thessaloniki: collaborator

Related Publications (3)

• Giamarellos-Bourboulis EJ, Bengmark S, Kanellakopoulou K, Kotzampassi K. Pro- and synbiotics to control inflammation and infection in patients with multiple injuries. J Trauma. 2009 Oct;67(4):815-21. doi: 10.1097/TA.0b013e31819d979e.

  PMID: 19820590 BACKGROUND

• Kotzampassi K, Giamarellos-Bourboulis EJ, Voudouris A, Kazamias P, Eleftheriadis E. Benefits of a synbiotic formula (Synbiotic 2000Forte) in critically Ill trauma patients: early results of a randomized controlled trial. World J Surg. 2006 Oct;30(10):1848-55. doi: 10.1007/s00268-005-0653-1.

  PMID: 16983476 BACKGROUND

• Kotzampassi K, Stavrou G, Damoraki G, Georgitsi M, Basdanis G, Tsaousi G, Giamarellos-Bourboulis EJ. A Four-Probiotics Regimen Reduces Postoperative Complications After Colorectal Surgery: A Randomized, Double-Blind, Placebo-Controlled Study. World J Surg. 2015 Nov;39(11):2776-83. doi: 10.1007/s00268-015-3071-z.

  PMID: 25894405 DERIVED

MeSH Terms

Conditions

Postoperative Complications; Infections; Anastomotic Leak

Interventions

Probiotics; Lacteol

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Katerina Kotxampassi, MD, PhD

  AXEPA University of Thessaloniki, 1st Department of Propedeutic Surgery, Thessaloniki, Greece

  STUDY CHAIR

• Evangelos Giamarellos-Bourboulis, MD, PhD

  University of Athens, 4th Department of Internal Medicine, Athens, Greece

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: December 8, 2014
• First Posted: December 10, 2014
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-12