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

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ClinicalTrials.gov Identifier: NCT03772444
Recruitment Status : Unknown
Verified December 2018 by GIHeelkunde, University Hospital, Ghent.
Recruitment status was:  Recruiting
First Posted : December 11, 2018
Last Update Posted : December 13, 2018
Sponsor:
Collaborator:
University Ghent
Information provided by (Responsible Party):
GIHeelkunde, University Hospital, Ghent

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Postoperative Ileus Dietary Supplement: Beetroot juice Dietary Supplement: Nitrate-depleted beetroot juice Dietary Supplement: Water Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Patients undergoing colorectal surgery will be randomized (n=10) to receive one week daily 70 ml of beetroot juice (~ 7 mmol inorganic nitrate) or (n=10) an equivalent volume of nitrate-depleted beetroot juice (control group 1). An additional control group (n=10) is added to the pilot study, in which patients will receive an equivalent volume of water (control group 2); this allows us to investigate whether the antioxidants present in beetroot juice contribute to the protective effect of beetroot juice in POI. Beetroot juice and nitrate-depleted beetroot juice cause discoloration of urine (beeturia) and feces from the purple betacyanin pigments in beetroot; for the control group that receives water, this will not be the case and blinding for this group is thus not possible.
Primary Purpose: Prevention
Official Title: Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. Time until recovery of gastrointestinal function. [ Time Frame: up to 30 days after surgery ]
    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.


Secondary Outcome Measures :
  1. Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days). [ Time Frame: up to 30 days after surgery ]
  2. Overall post-operative complication rate defined according to the Clavien-Dindo Classification. [ Time Frame: 3 months postoperatively ]
  3. Presence of prolonged postoperative ileus. [ Time Frame: up to 30 days after surgery ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03772444


Contacts
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Contact: Wim Ceelen +32(0)93326251 wim.ceelen@ugent.be
Contact: Sarah Cosyns +32(0)93321562 sarah.cosyns@ugent.be

Locations
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Belgium
Ghent University Hospital Recruiting
Gent, Belgium, 9000
Contact: Wim Ceelen    +32(0)93326251    wim.ceelen@ugent.be   
Sub-Investigator: Sarah Cosyns         
Sponsors and Collaborators
University Hospital, Ghent
University Ghent
More Information
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Responsible Party: GIHeelkunde, Prof. Dr. Wim Ceelen, University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT03772444    
Other Study ID Numbers: EC/2017/1476
First Posted: December 11, 2018    Key Record Dates
Last Update Posted: December 13, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ileus
Intestinal Obstruction
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases