Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05133024

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

352 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

The goal of the BEET IT study is to examine if preoperative intake of beetroot juice can ameliorate gastrointestinal (GI) recovery after colorectal surgery and thereby help to reduce the duration of postoperative ileus (POI) and prevent prolonged POI. Adult patients undergoing laparoscopic colorectal surgery are randomized 1:1 to consume either concentrated beetroot juice (active intervention) or nitrate-depleted concentrated beetroot juice (placebo) during the week before their surgery. Blood, tissue and/or fecal samples are collected at specific time points pre- and/or postoperatively to study markers related to inflammation, oxidative stress and GI function. Patients are followed from the week before surgery (start of the intervention) until 3 months post-surgery. The study takes place at 5 hospitals in Flanders, Belgium.

CONDITIONS

Official 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 the need of conversion
Not Eligible

You will not qualify if you...

General:

  • < 18 years of age
  • Pregnancy or breast feeding

Medical:

  • Psychiatric pathology capable of affecting comprehension and judgment faculty
  • History of inflammatory bowel disease
  • Chronic vascular disease affecting the intestines
  • Chronic constipation (<= 2 bowel movements/week)
  • Previous abdominal or pelvic radiation treatment
  • Recent (< 3 months before inclusion) or current intra-abdominal infection or inflammation (e.g. diverticulitis, appendicitis, cholecystitis)
  • Use of gut motility influencing agents (e.g. tricyclic antidepressants, chronic use of laxatives)
  • Use of nitrates (e.g. isosorbide dinitrate, nitroglycerin), including daily consumption of beetroot juice (unless stopped for a month prior to the intervention period)
  • Hypotension (< 100/60 mmHg)
  • Uncontrolled diabetes mellitus
  • Renal or hepatic insufficiency
  • Known allergies or intolerances to beetroot, nitrates/nitrites
  • Enrollment in other clinical trials/experiments, unless approved by the Ethics Committee(s)

Surgical:

  • History of prior colorectal surgery
  • Emergency surgery
  • Open surgery
  • Colorectal surgery not requiring an anastomosis (e.g. colotomy, wedge resection)
  • More than 1 bowel anastomosis planned
  • Concomitant surgical procedures required (e.g. resection of liver or lung metastases)
  • Protective stoma planned

AI-Screening

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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

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Research Team

W

Wim Ceelen, MD, PhD

CONTACT

K

Karen De Meuleneir, MSc

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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