Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID05133024

Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

Led by University Hospital, Ghent · Updated on 2026-02-10

170

Participants Needed

6

Research Sites

65 weeks

Total Duration

On this page

Sponsors

U

University Hospital, Ghent

Lead Sponsor

R

Research Foundation Flanders

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating if drinking beetroot juice before laparoscopic colorectal surgery can improve recovery of the digestive system and reduce how long postoperative ileus (POI) lasts. POI is a common complication after abdominal surgery, causing nausea, vomiting, and delayed bowel movements, sometimes lasting longer and leading to more health problems and longer hospital stays. Beetroot juice is rich in nitrate, which may help restore nitric oxide levels important in healing and inflammation, potentially aiding recovery. This study is a phase II multicenter, double-blind, randomized controlled trial involving adult patients undergoing elective colorectal surgery. Participants are randomly assigned to one of two groups: one group drinks seven daily 70 mL shots of concentrated beetroot juice before surgery, while the other group drinks nitrate-depleted beetroot juice as a placebo for the same period. The intervention starts one week before surgery. The beetroot juice is provided by BEET IT sport NITRATE 400, and both active and placebo shots are taken once daily in the morning for seven consecutive days. The study includes blood, tissue, and fecal sample collection at specific times before and after surgery to analyze markers of inflammation, oxidative stress, and gastrointestinal function. Participants are followed from one week before surgery until three months after surgery. Researchers will monitor recovery times of gastrointestinal function, including times until first passage of gas and stool, and tolerance of liquids and foods. They will also track the incidence of prolonged POI, length of hospital stay, postoperative complications up to three months, and biomarker levels at four time points. The study uses quadruple masking to ensure unbiased results and takes place at five hospitals in Flanders, Belgium.

CONDITIONS

Brief Title

Use of Beetroot Juice to Protect Against Postoperative Ileus Following Colorectal Surgery: BEET IT Study

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients undergoing elective colonic and upper rectum laparoscopic surgery requiring an anastomosis, without need for conversion
Not Eligible

You will not qualify if you...

  • Under 18 years of age
  • Pregnancy or breastfeeding
  • Psychiatric conditions affecting understanding or judgment
  • History of inflammatory bowel disease
  • Chronic vascular disease affecting intestines
  • Chronic constipation (2 or fewer bowel movements per week)
  • Previous abdominal or pelvic radiation treatment
  • Recent or current intra-abdominal infection or inflammation (within 3 months)
  • Use of medications affecting gut motility (e.g., tricyclic antidepressants, chronic laxatives)
  • Use of nitrates including daily beetroot juice unless stopped for one month before intervention
  • Low blood pressure (less than 100/60 mmHg)
  • Uncontrolled diabetes mellitus
  • Kidney or liver failure
  • Known allergy or intolerance to beetroot or nitrates/nitrites
  • Participation in other clinical trials unless approved by Ethics Committee
  • History of prior colorectal surgery
  • Emergency surgery
  • Open surgery
  • Colorectal surgery not requiring an anastomosis
  • More than one bowel anastomosis planned
  • Required additional surgical procedures (e.g., liver or lung metastases resection)
  • Planned protective stoma

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 7 days before surgery

Participants take 7 daily shots of either concentrated beetroot juice or nitrate-depleted placebo juice in the morning for 7 consecutive days before surgery.

7 daily visits or self-administrations before surgery

Surgery and Immediate Post-operative Care

Duration - Until hospital discharge after surgery

Participants undergo laparoscopic colorectal surgery followed by immediate post-operative care focusing on gastrointestinal recovery.

Hospital stay visits until discharge

Post-operative Follow-up

Duration - Up to 3 months after surgery

Participants are monitored for postoperative complications and gastrointestinal function recovery for up to 3 months after surgery.

Follow-up visits during 3 months post-surgery

Trial Site Locations

Total: 6 locations

1

Antwerp University Hospital

Edegem, Belgium, 2650

Actively Recruiting

2

Hospital East-Limburg

Genk, Belgium, 3600

Active, Not Recruiting

3

AZ Sint-Lucas Ghent

Ghent, Belgium, 9000

Actively Recruiting

4

Ghent University Hospital

Ghent, Belgium, 9000

Actively Recruiting

5

University Hospital Leuven

Leuven, Belgium, 3000

Actively Recruiting

6

VITAZ

Sint-Niklaas, Belgium, 9100

Actively Recruiting

Loading map...

Research Team

W

Wim Ceelen, MD, PhD

K

Karen De Meuleneir, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

Similar Trials

Dexamethasone in the Prevention of Post-spinal Paralytic Ile...

Postoperative Ileus

Actively Recruiting

1 location

A Multicenter, Randomized Controlled Trial to Evaluate the E...

Colorectal Cancer

Actively Recruiting

1 location

Gastrointestinal Stimulation As a Treatment of Postoperative...

Postoperative Ileus

Actively Recruiting

1 location

Frequently Asked Questions

Have more questions? Get in touch with our team for quick support

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here