An interventional study of Beetroot juice and Nitrate-depleted beetroot juice in Postoperative Ileus, sponsored by University Hospital, Ghent. Terminated at 1 site in Belgium. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2023-01-20.
Sponsored by University Hospital, Ghent · Not applicable, Interventional, and Prevention
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).
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's enrollment of 12 is below the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →University Hospital, Ghent is the lead sponsor of 689 studies on the registry; 160 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Beetroot juice
Dietary Supplement: Nitrate-depleted beetroot juice
Dietary Supplement: Water
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.
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.
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.
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.
Time frame: up to 30 days after surgery
Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
Time frame: up to 30 days after surgery
Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
Time frame: 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.
Time frame: up to 30 days after surgery
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beet juice