Postoperative IleusBEET ITNCT03772444
Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
A study testing Beetroot juice, Nitrate-depleted beetroot juice and Water in people with Postoperative Ileus, run by University Hospital, Ghent at 1 site in Belgium.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Postoperative Ileus
- What is being tested?
- Beetroot juice, Nitrate-depleted beetroot juice and Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteBelgium
- Study dates
- 15 Jan 2018to 25 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing colonic or upper rectum laparoscopic surgery.
Who cannot join
- 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)
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Postoperative Ileus
- Being tested
- Beetroot juice, Nitrate-depleted beetroot juice, Water
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
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.
Nitrate-depleted beetroot juiceDietary supplement
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.
WaterDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Active comparator | Not described Receives: Dietary Supplement: Beetroot juice |
| Control group 1 | Placebo comparator | Not described Receives: Dietary Supplement: Nitrate-depleted beetroot juice |
| Control group 2 | Sham comparator | Not described Receives: Dietary Supplement: Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days after surgery
Secondary outcomes (3)
Time until passage of stool, flatus or until tolerance of (semi-)solid oral diet (in days).
Measured: up to 30 days after surgery
Overall post-operative complication rate defined according to the Clavien-Dindo Classification.
Measured: 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.
Measured: up to 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start15 Jan 2018
- Primary completion25 May 2019
- Study completion25 May 2019
Why it stopped: The pilot study was set up to assess whether the used dosing regimen of beetroot juice demonstrated to reach the therapeutic objective. The study was terminated early, as the deadline for the grant application for a larger study was approaching.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative IleusStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- University Ghent
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772444
- Sponsor's protocol ID
- EC/2017/1476
- Acronym
- BEET IT
- Status last verified
- Jan 2023
- First submitted
- 5 Dec 2018
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Beetroot Juice to Protect Against Postoperative Ileus (POI) Following Colorectal Surgery: a Pilot Study.
- ClinicalTrials.gov ID
- NCT03772444
- Acronym / sponsor ID
- BEET IT / EC/2017/1476
- Conditions
- Postoperative Ileus
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The pilot study was set up to assess whether the used dosing regimen of beetroot juice demonstrated to reach the therapeutic objective. The study was terminated early, as the deadline for the grant application for a larger study was approaching.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- University Ghent
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 25 May 2019 (actual)
- Study completion
- 25 May 2019 (actual)
- First posted
- 11 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Active comparator | Dietary Supplement: Beetroot juice |
| Control group 1 | Placebo comparator | Dietary Supplement: Nitrate-depleted beetroot juice |
| Control group 2 | Sham comparator | Dietary Supplement: Water |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing colonic or upper rectum laparoscopic surgery.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juicePatients 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. | Dietary supplement | Beetroot juice |
| Nitrate-depleted beetroot juicePatients 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. | Dietary supplement | Control group 1 |
| WaterPatients 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. | Dietary supplement | Control group 2 |
Primary outcome
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.
3 secondary outcomes
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.
Time frame: up to 30 days after surgery
Results and safety
The study was stopped early (reason given: The pilot study was set up to assess whether the used dosing regimen of beetroot juice demonstrated to reach the therapeutic objective. The study was terminated early, as the deadline for the grant application for a larger study was approaching.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot juice, Nitrate-depleted beetroot juice and Water in people with Postoperative Ileus, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The pilot study was set up to assess whether the used dosing regimen of beetroot juice demonstrated to reach the therapeutic objective. The study was terminated early, as the deadline for the grant application for a larger study was approaching.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time until recovery of gastrointestinal function. (time frame: up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.