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

Ghent University Hospital (UZ)

Status: Terminated

Conditions: Postoperative Ileus

Treatments: Dietary Supplement: Beetroot juice; Dietary Supplement: Water; Dietary Supplement: Nitrate-depleted beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT03772444

EC/2017/1476

Details and patient eligibility

About

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).

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 18 to 95 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 3 patient groups, including a placebo group

Beetroot juice

Active Comparator group

Treatment:

Dietary Supplement: Beetroot juice

Control group 1

Placebo Comparator group

Treatment:

Dietary Supplement: Nitrate-depleted beetroot juice

Control group 2

Sham Comparator group

Treatment:

Dietary Supplement: Water