Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study. (BEET IT)

The BEET IT study investigates the possible protective effect of beetroot juice on POI following colorectal surgery in (partially) blinded single-center phase 2 randomized trial (pilot study).

Study Overview

• Status: Terminated
• Conditions: Postoperative Ileus
• Intervention / Treatment: Dietary supplement: Beetroot juice; Dietary supplement: Nitrate-depleted beetroot juice; Dietary supplement: Water

Detailed Description

Postoperative ileus (POI) is a transient impairment of gastrointestinal motility following abdominal surgery, which leads to increased morbidity, prolonged hospitalization and increased healthcare cost. The pathogenesis of POI involves inflammation and oxidative stress, similar to ischemia/reperfusion injury that can be counteracted with beetroot juice. Beetroot juice is a source of inorganic nitrate, which by conversion of nitrate to nitrite in the body, exerts its protective effect. We before demonstrated in a preclinical model that administration of exogenous nitrite was shown to protect against POI. The aim of this pilot study is to investigate the possible protective effect of beetroot juice ingestion on POI following colorectal surgery.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Wim Ceelen; Phone Number: +32(0)93326251; Email: wim.ceelen@ugent.be
• Study Contact Backup: Name: Sarah Cosyns; Phone Number: +32(0)93321562; Email: sarah.cosyns@ugent.be

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Ghent University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients undergoing colonic or upper rectum laparoscopic surgery.

Exclusion Criteria:

• Pregnancy or breast feeding
• Psychiatric pathology capable of affecting comprehension and judgment faculty
• History of metastatic disease
• History of prior abdominal bowel surgery
• Abdominal radiation treatment
• Chronic constipation (defined as two or fewer bowel movements per week)
• Gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
• Frequent use of mouthwash, as this affects the enterosalivary circulation of nitrate
• Current use of broad-spectrum antibiotics, which will affect the oral flora and likely affect the nitrate reductase activity
• More than one bowel anastomosis during this surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beetroot juice	Dietary supplement: Beetroot juice; Patients will drink 70 ml of beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
Placebo Comparator: Control group 1	Dietary supplement: Nitrate-depleted beetroot juice; Patients will drink 70 ml of nitrate-depleted beetroot juice daily in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.
Sham Comparator: Control group 2	Dietary supplement: Water; Patients will drink 70 ml of water in the week prior to surgery; the last dose will be administered via the nasogastric tube just before the start of the procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until recovery of gastrointestinal function.	Recovery of gastrointestinal function is defined as the interval (in days) from the end of surgery until passage of stool AND tolerance of solid food.	up to 30 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).		up to 30 days after surgery
Overall post-operative complication rate defined according to the Clavien-Dindo Classification.		3 months postoperatively
Presence of prolonged postoperative ileus.	Prolonged postoperative ileus is defined as presence of 2 or more of the following criteria on or after day 4 postoperatively: nausea or vomiting, inability to tolerate a solid or semi-solid oral diet, abdominal distension, absence of flatus and stool, radiological evidence of ileus.	up to 30 days after surgery

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2018
• Primary Completion (Actual): May 25, 2019
• Study Completion (Actual): May 25, 2019

Study Registration Dates

• First Submitted: December 5, 2018
• First Submitted That Met QC Criteria: December 10, 2018
• First Posted (Actual): December 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 20, 2023
• Last Update Submitted That Met QC Criteria: January 18, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Obstruction; Ileus
• Other Study ID Numbers: EC/2017/1476

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No