Colonic DiseasesDIETCOLNCT02401802
Low-fiber Diet for Colorectal Cancer Screening Colonoscopy
A study testing Low-residue diet in people with Colonic Diseases, run by Parc de Salut Mar at 1 site in Spain.
Trial summary
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colonic Diseases
- What is being tested?
- Low-residue diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 276 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2015to Dec 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.
Who cannot join
- Unwillingness to participate.
- Inability to follow instructions
- Active inflammatory bowel disease
- Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
Read the detailed description
There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.
All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.
- Conditions
- Colonic Diseases
- Being tested
- Low-residue diet, Usual care
- Keywords
- Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening
- Medical subject headings
- Colonic Diseases, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-residue dietDietary supplement
Subjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days
Usual careDietary supplement
Subjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet
| Study group | Role | What they receive |
|---|---|---|
| Low-residue diet | Experimental | The experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion. Receives: Dietary Supplement: Low-residue diet |
| Usual care | Active comparator | The control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet.
Laxative 4 liters polyethylene glycol 4000 in split fashion. Receives: Dietary Supplement: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inadequate bowel preparation.
The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation
Measured: 1 hour after the colonoscopy
Secondary outcomes (10)
Cecal intubation rate
Ratio of successful cecal intubations in each study arm
Measured: 1 hour after the colonoscopy
Adenoma detection rate
Ratio of polyps and adenomas detected in each study arm
Measured: 1 hour after the colonoscopy
Polyp detection rate
Ratio of polyps and adenomas detected in each study arm
Measured: 1 hour after the colonoscopy
Abdominal pain
Each participant will rate his/her experience in an analogue visual scale
Measured: 6 hours after finishing bowel preparation
Nausea
Each participant will rate his/her experience in an analogue visual scale
Measured: 6 hours after finishing bowel preparation
Hunger
Each participant will rate his/her experience in an analogue visual scale
Measured: 6 hours after finishing bowel preparation
Bloating
Each participant will rate his/her experience in an analogue visual scale
Measured: 6 hours after finishing bowel preparation
Adverse events
Description of all spontaneously reported adverse events.
Measured: 30 days after the colonoscopy
Adherence to the planned bowel cleansing method (questionnaire)
Each participant will rate his/her experience in a questionnaire.
Measured: 6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep
Each participant will rate his/her experience in a questionnaire.
Measured: 6 hours after finishing bowel preparation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Colonic DiseasesStudies of the same condition, open and under way.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 276 participants (actual)
Sponsor and investigators
- Lead sponsor
- Parc de Salut Mar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marco Antonio Alvarez Gonzalez, Parc de Salut Mar
- Investigators
- Marco Antonio Alvarez González, MD, PhD, Principal investigator, Parc de Salut Mar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401802
- Sponsor's protocol ID
- DIETCOL
- Acronym
- DIETCOL
- Status last verified
- Feb 2017
- First submitted
- 17 Mar 2015
- Last updated
- 15 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Soweid AM, Kobeissy AA, Jamali FR, El-Tarchichi M, Skoury A, Abdul-Baki H, El-Zahabi L, El-Sayyed A, Barada KA, Sharara AI, Mourad F, Arabi A. A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation. Endoscopy. 2010 Aug;42(8):633-8. doi: 10.1055/s-0029-1244236. Epub 2010 Jul 9.
PubMed 20623443Alvarez-Gonzalez MA, Pantaleon MA, Flores-Le Roux JA, Zaffalon D, Amoros J, Bessa X, Seoane A, Pedro-Botet J; PROCOLON group. Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy. Dis Colon Rectum. 2019 Apr;62(4):491-497. doi: 10.1097/DCR.0000000000001305.
PubMed 30844973
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-fiber Diet for Colorectal Cancer Screening Colonoscopy. Randomized Clinical Trial. Dietcol Study
- ClinicalTrials.gov ID
- NCT02401802
- Acronym / sponsor ID
- DIETCOL / DIETCOL
- Conditions
- Colonic Diseases
- Keywords
- Colonoscopy, Diet, Polyethylene glycols, Efficacy, Personal satisfaction, Colorectal cancer screening
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 276 participants (actual)
- Lead sponsor
- Parc de Salut MarUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 30 Mar 2015 (estimated)
- 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.
This trial will compare the efficacy of 2 different sets of dietary recommendations to be followed before colon cleansing for colorectal cancer screening colonoscopy.
Detailed description
There is no enough evidence in the literature to recommend a low-fiber diet for screening colonoscopy. Although evidence of benefit of a liquid diet is minimal and there is a growing body of evidence about the benefits of a liberalized diet, a high degree of heterogeneity in the clinical trials comparing the diet modifications before colonoscopy prevents a formal recommendation in current guidelines. A low-fiber diet the day before colonoscopy may result in same efficacy of bowel cleanliness, with an improved tolerability and acceptability.
All consecutive patients of a population-based colorectal screening cancer program referred for a colonoscopy will be invited to participate in the study. After obtaining informed consent, they will be randomized to one of the groups: liquid diet or low-fiber diet. The will be interviewed by a registered research nurse, and they will be provided with written instructions for bowel preparation and questionnaires for registering the data of the study. The day of the colonoscopy, questionnaires will be collected and endoscopists blinded for the study bowel preparation will perform the colonoscopy. Patients will be contacted for adverse events and a general satisfaction questionnaire, 3 days after colonoscopy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-residue diet | Experimental | Dietary Supplement: Low-residue dietThe experimental group will receive 4 days of low-residue diet Laxative 4 liters polyethylene glycol 4000 in split fashion. |
| Usual care | Active comparator | Dietary Supplement: Usual careThe control group will receive 3 days of low-residue diet followed by 24 hours of liquid diet. Laxative 4 liters polyethylene glycol 4000 in split fashion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients referred for a colonoscopy in a population-based colorectal screening program.
Key exclusion criteria (4 listed)
- Unwillingness to participate.
- Inability to follow instructions
- Active inflammatory bowel disease
- Incomplete colonoscopies for technical reasons or contraindication as evaluated by the endoscopist
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 |
|---|---|---|
| Low-residue dietSubjects will be instructed by members of the research team to follow a standardized low residue diet for 4 days | Dietary supplement | Low-residue diet |
| Usual careSubjects will be instructed by members of the research team to follow a low-residue diet for 3 days followed by 24 hours of liquid diet | Dietary supplement | Usual care |
Primary outcome
Inadequate bowel preparation.
Time frame: 1 hour after the colonoscopy
The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Colonoscopies with a BBPS score of less than 5 points, or any segment rated less than 2 points will be considered with an inadequate bowel preparation
10 secondary outcomes
Cecal intubation rate
Time frame: 1 hour after the colonoscopy
Adenoma detection rate
Time frame: 1 hour after the colonoscopy
Polyp detection rate
Time frame: 1 hour after the colonoscopy
Abdominal pain
Time frame: 6 hours after finishing bowel preparation
Nausea
Time frame: 6 hours after finishing bowel preparation
Hunger
Time frame: 6 hours after finishing bowel preparation
Bloating
Time frame: 6 hours after finishing bowel preparation
Adverse events
Time frame: 30 days after the colonoscopy
Adherence to the planned bowel cleansing method (questionnaire)
Time frame: 6 hours after finishing bowel preparation
Acceptability of the preparation (interference with work, leisure activities or sleep
Time frame: 6 hours after finishing bowel preparation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Background: PubMed 20623443Soweid AM, Kobeissy AA, Jamali FR, El-Tarchichi M, Skoury A, Abdul-Baki H, El-Zahabi L, El-Sayyed A, Barada KA, Sharara AI, Mourad F, Arabi A. A randomized single-blind trial of standard diet versus fiber-free diet with polyethylene glycol electrolyte solution for colonoscopy preparation. Endoscopy. 2010 Aug;42(8):633-8. doi: 10.1055/s-0029-1244236. Epub 2010 Jul 9.
- Derived from this study: PubMed 30844973Alvarez-Gonzalez MA, Pantaleon MA, Flores-Le Roux JA, Zaffalon D, Amoros J, Bessa X, Seoane A, Pedro-Botet J; PROCOLON group. Randomized Clinical Trial: A Normocaloric Low-Fiber Diet the Day Before Colonoscopy Is the Most Effective Approach to Bowel Preparation in Colorectal Cancer Screening Colonoscopy. Dis Colon Rectum. 2019 Apr;62(4):491-497. doi: 10.1097/DCR.0000000000001305.
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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.
Marco Antonio Alvarez González, MD, PhD principal investigator
Parc de Salut Mar
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-residue diet in people with Colonic Diseases, run by Parc de Salut Mar at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 15 Feb 2017. 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 Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Inadequate bowel preparation. (time frame: 1 hour after the colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02401802, which also lists 2 linked publications.
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 15 Feb 2017.