Bowel PreparationDinNER1006NCT06651398
A Study to Investigate the Effect of a Meal At 6pm the Day Before the Colonoscopy on the Bowel Cleansing with Plenvu
A study testing Lenient diet in people with Bowel Preparation and Bowel Preparation for Colonoscopy, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Bowel Preparation, Bowel Preparation for Colonoscopy, Bowel Cleansing for Colonoscopy
- What is being tested?
- Lenient diet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 525 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Feb 2023to Nov 2024
- 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 40 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient referred for diagnostic colonoscopy
- Age between 40 and 85 years old
- Ability of normal oral ingestion
- Able to give informed consent by the patient or the legal representative
Who cannot join
- Participant has a history of (partial) colectomy, excluding appendectomy
- Inability of oral ingestion
- Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
- Uncontrolled coagulopathy
- Pregnancy
- Premenopausal women not adhering to any contraceptive method
Show all 19Show fewer
- Inflammatory bowel disease
- Lynch syndrome
- Familial adenomatosis polyposis syndrome
- Serrated polyposis syndrome
- hypersensitivity to the active substances of PLENVU as listed in the SmPC section 6.1
- gastrointestinal obstruction or perforation
- ileus
- gastric emptying disorders (e.g. gastroparesis, gastric retention, etc.)
- phenylketonuria (due to the presence of aspartame in PLENVU)
- glucose-6-phosphate dehydrogenase deficiency (due to the presence of ascorbate in PLENVU)
- toxic megacolon
- Any disorder, which in the Investigator's opinion might jeopardise the participant's safety or compliance with the protocol
- Any prior or concomitant treatment(s) that might jeopardise the participant's safety or that would compromise the integrity of the Trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy
Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.
- Conditions
- Bowel Preparation, Bowel Preparation for Colonoscopy, Bowel Cleansing for Colonoscopy, Healthy
- Being tested
- Lenient diet
- Keywords
- bowel preparation, colonoscopy preparation, bowel cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lenient dietBehavioural
The interventional goup receives the lenient diet instructions and will eat a light meal until 18h on the day before the colonoscopy. The first dose of Plenvu will be started at 20h. All the other bowel preparation instructions will be the same as in the control group.
| Study group | Role | What they receive |
|---|---|---|
| Lenient diet | Experimental | This group can have a less stringent diet compared to the current standard of care and eat a light meal until 18h before drinking the first dose of the bowel preparation on the day before the colonoscopy Receives: Behavioral: Lenient diet |
| Control group | No intervention | This group follows the strict diet similar to what is currently used in standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
Measured: Max 12 weeks
Secondary outcomes (4)
Number of patients with an optimal bowel preparation (BBPS 8-9)
Measured: Max 12 weeks
Detection rates
Adenoma Detection Rate (ADR), Polyp Detection Rate (PDR), Serrated Polyp Detection Rate (SPDR), Advanced Adenoma Detection Rate (aADR)
Measured: Max 12 weeks
Number of patients with high-quality right sided colon preparation (subscore = 3)
Measured: Max 12 weeks
Overall patient's tolerance, adherence and satisfaction based on the patient's diary
Measured: Max 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2024
- Study start14 Feb 2023
- Primary completionNov 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bowel PreparationStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 525 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- Norgine BV
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651398
- Sponsor's protocol ID
- S66191
- Acronym
- DinNER1006
- Status last verified
- Oct 2024
- First submitted
- 18 Oct 2024
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Dine or Not to Dine: Effect of Day-before Light Dinner on Bowel Cleansing Prior to Colonoscopy
- ClinicalTrials.gov ID
- NCT06651398
- Acronym / sponsor ID
- DinNER1006 / S66191
- Conditions
- Bowel Preparation, Bowel Preparation for Colonoscopy, Bowel Cleansing for Colonoscopy, Healthy
- Keywords
- bowel preparation, colonoscopy preparation, bowel cleansing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 525 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Collaborators
- Norgine BV
- Study start
- 14 Feb 2023 (actual)
- Primary completion
- Nov 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 21 Oct 2024 (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.
Bowel cleansing prior to colonoscopy is crucial to be able to perform a high-quality examination. Therefore maximum efforts are made to achieve optimal bowel cleansing including diet restriction and refraining from day-before dinner. However, the effect of this interdiction is currently not clear. On the other hand, patient compliance and experience with the entire procedure is important, especially for follow-up colonoscopies. Strict diets may interfere with this as an additional burden on the patient. In this study we want to assess whether a more lenient diet influences the quality of bowel preparation and whether it improves patient's experience.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lenient diet | Experimental | Behavioral: Lenient dietThis group can have a less stringent diet compared to the current standard of care and eat a light meal until 18h before drinking the first dose of the bowel preparation on the day before the colonoscopy |
| Control group | No intervention | –This group follows the strict diet similar to what is currently used in standard of care. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient referred for diagnostic colonoscopy
- Age between 40 and 85 years old
- Ability of normal oral ingestion
- Able to give informed consent by the patient or the legal representative
Key exclusion criteria (19 listed)
- Participant has a history of (partial) colectomy, excluding appendectomy
- Inability of oral ingestion
- Chronic severe constipation, defined as the need for daily laxative use of any kind or the need to use laxatives to obtain defaecation.
- Uncontrolled coagulopathy
- Pregnancy
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 |
|---|---|---|
| Lenient dietThe interventional goup receives the lenient diet instructions and will eat a light meal until 18h on the day before the colonoscopy. The first dose of Plenvu will be started at 20h. All the other bowel preparation instructions will be the same as in the control group. | Behavioural | Lenient diet |
Primary outcome
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1)
Time frame: Max 12 weeks
4 secondary outcomes
Number of patients with an optimal bowel preparation (BBPS 8-9)
Time frame: Max 12 weeks
Detection rates
Time frame: Max 12 weeks
Number of patients with high-quality right sided colon preparation (subscore = 3)
Time frame: Max 12 weeks
Overall patient's tolerance, adherence and satisfaction based on the patient's diary
Time frame: Max 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
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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 Lenient diet in people with Bowel Preparation and Bowel Preparation for Colonoscopy, run by Universitaire Ziekenhuizen KU Leuven 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 4 inclusion and 19 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: status not confirmed, as of the sponsor's last update on 21 Oct 2024. 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. 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?
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?
Number of patients with an adequate bowel preparation (BBPS ≥6, and no segmental subscore ≤1) (time frame: Max 12 weeks). 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 21 Oct 2024.