Cleansing Quality of the ColonDIETPREPNCT03247452
Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)
A study testing One-day Low fiber diet, Three-day low fiber diet and Polyethylene Glycol plus ascorbic acid in people with Cleansing Quality of the Colon, run by Hospital Universitario de Canarias at 1 site in Spain.
Trial summary
This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cleansing Quality of the Colon
- What is being tested?
- One-day Low fiber diet, Three-day low fiber diet and Polyethylene Glycol plus ascorbic acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 404 participants
- Where
- 1 siteSpain
- Study dates
- 18 Dec 2017to 1 Jul 2018
- 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
- Age ≥ 18 years
Who cannot join
- Patients with previous colon surgery
- Last colonoscopy with poor bowel preparation
- Ileus, intestinal obstruction, megacolon
- Poorly controlled hypertension (HTAS> 180 HTAD> 100)
- Terminal renal failure (pre-dialysis or dialysis)
- Congestive heart failure (NYHA III-IV)
Show all 14Show fewer
- Acute liver failure
- Severe psychiatric illness
- Dementia with difficulty in the intake of the preparation
- Pregnancy or breastfeeding
- Phenylketonuria
- Deficiency of glucose-6-phosphate dehydrogenase
- Refusal to participate in the study
- Inability to follow the instructions
Trial locations and contacts
1 site in 1 country.
Spain1 site
Department of Gastroenterology
San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320
About this study
Official title: Impact of Low Fiber Diet on Colonic Cleansing Quality Prior to Colonoscopy: Randomized Study Comparing 1 Day Versus 3 Days of Low Fiber Diet
This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet.
Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.
Read the detailed description
It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid diet. However, tolerance is better with low fiber diet. There is no current evidence whether the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing quality.
This is the first controlled, randomized trial to compare bowel cleansing by using two different protocols: one day low fiber diet versus three day low fiber diet.
A researcher will offer to participate in the study to scheduled for outpatient colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. Thus, according to the allocation group, participants must comply with a low fiber diet the previous day of the examination or 3 days prior to the examination. In both cases, patients will take a liquid diet the night before.
Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with ascorbic acid 5 hours before the appointment for colonoscopy.
Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.
The hypothesis of the study is that in non-selected population, a 3-day low fiber diet before colonoscopy is superior to 1-day low fiber diet in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).
For the present study, a 10% improvement in the quality of colonic cleaning was hypothesized in the group of patients receiving 3 day low fiber diet regimen. Taking into account a power of 80%, alpha error of 5% and losses of 15% will require 202 patients per group.
- Conditions
- Cleansing Quality of the Colon
- Being tested
- One-day Low fiber diet, Three-day low fiber diet, Polyethylene Glycol plus ascorbic acid
- Keywords
- Low fiber diet, Colonoscopy, Bowel Cleansing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One-day Low fiber dietOther
One-day low fiber diet before colonoscopy
Three-day low fiber dietOther
Three days low fiber diet before colonoscopy
Polyethylene Glycol plus ascorbic acidDrug
2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
| Study group | Role | What they receive |
|---|---|---|
| One-day low fiber diet | Active comparator | Patients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered Receives: Other: One-day Low fiber diet; Drug: Polyethylene Glycol plus ascorbic acid |
| Three-day low fiber diet | Experimental | Patients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy.
2 liters of polyethylene glycol plus ascorbic acid will be administered Receives: Other: Three-day low fiber diet; Drug: Polyethylene Glycol plus ascorbic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Boston Bowel Preparation Scale
This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points
Measured: 7 months
Secondary outcomes (2)
Proportion of polyps detected in each arm
Number of polyps detected in one arm/total of polyps detected
Measured: 7 months
Degree of satisfaction with diet
It will be assessed using a visual scale (1 excellent to 10 unbearable)
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2017
- Study start18 Dec 2017
- Primary completion31 Mar 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Cleansing Quality of the ColonStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Canarias
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Enrique Quintero, MD, PhD, Study director, Hospital Universitario de Canarias
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03247452
- Sponsor's protocol ID
- Large bowel cleansing
- Acronym
- DIETPREP
- Status last verified
- Aug 2018
- First submitted
- 9 Aug 2017
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
PubMed 23335011Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
PubMed 26735547Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
PubMed 28282690Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.
PubMed 21160321Gimeno-Garcia AZ, de la Barreda Heuser R, Reygosa C, Hernandez A, Mascareno I, Nicolas-Perez D, Jimenez A, Lara AJ, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez G, Hernandez D, Delgado R, Quintero E. Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial. Endoscopy. 2019 Jul;51(7):628-636. doi: 10.1055/a-0864-1942. Epub 2019 Apr 3.
PubMed 30943553
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low Fiber Diet on Colonic Cleansing Quality Prior to Colonoscopy: Randomized Study Comparing 1 Day Versus 3 Days of Low Fiber Diet
- ClinicalTrials.gov ID
- NCT03247452
- Acronym / sponsor ID
- DIETPREP / Large bowel cleansing
- Conditions
- Cleansing Quality of the Colon
- Keywords
- Low fiber diet, Colonoscopy, Bowel Cleansing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 404 participants (actual)
- Lead sponsor
- Hospital Universitario de CanariasUniversity, hospital or other
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 11 Aug 2017 (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.
This is a single center randomized controlled trial to compare bowel cleansing for outpatient colonoscopy in two groups of participants: one group will receive instructions of one-day structured low fiber diet whilst the other group will receive three-day low fiber diet.
Both groups will receive the same bowel cleansing solution (polyethylene glycol plus ascorbic acid). Bowel cleansing will be assessed according the Boston Bowel Preparation Scale.
Detailed description
It is well-known that low fiber diet before colonoscopy is at least equivalent to liquid diet. However, tolerance is better with low fiber diet. There is no current evidence whether the number of days on low fiber diet before colonoscopy have any influence on bowel cleansing quality.
This is the first controlled, randomized trial to compare bowel cleansing by using two different protocols: one day low fiber diet versus three day low fiber diet.
A researcher will offer to participate in the study to scheduled for outpatient colonoscopy, who meet all the inclusion criteria and none of the exclusion criteria. The researchers will explain the purpose of the study and will ask to sign the informed consent. They will give verbal and written information on the diet and the bowel cleansing solution to be taken. Thus, according to the allocation group, participants must comply with a low fiber diet the previous day of the examination or 3 days prior to the examination. In both cases, patients will take a liquid diet the night before.
Patients from both groups will receive low volume preparation with 1 L of polyethylene glycol plus ascorbic acid 12 hours prior to the appointment of the colonoscopy and 1 L of PEG with ascorbic acid 5 hours before the appointment for colonoscopy.
Patients must complete a baseline questionnaire at the inclusion visit and another questionnaire at the colonoscopy visit.
The hypothesis of the study is that in non-selected population, a 3-day low fiber diet before colonoscopy is superior to 1-day low fiber diet in achieving an acceptable bowel cleansing assessed by a validated scale (Boston Bowel Preparation Score).
For the present study, a 10% improvement in the quality of colonic cleaning was hypothesized in the group of patients receiving 3 day low fiber diet regimen. Taking into account a power of 80%, alpha error of 5% and losses of 15% will require 202 patients per group.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| One-day low fiber diet | Active comparator | Other: One-day Low fiber diet, Drug: Polyethylene Glycol plus ascorbic acidPatients assigned to the active comparator will receive oral and written instructions about the same structured low fiber diet designed by an Endocrinologist but they will follow this diet only the day before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered |
| Three-day low fiber diet | Experimental | Other: Three-day low fiber diet, Drug: Polyethylene Glycol plus ascorbic acidPatients assigned to the experimental group will receive oral and written instructions about a structured low fiber diet designed by an Endocrinologist. They must follow this diet three days before colonoscopy. 2 liters of polyethylene glycol plus ascorbic acid will be administered |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age ≥ 18 years
Key exclusion criteria (14 listed)
- Patients with previous colon surgery
- Last colonoscopy with poor bowel preparation
- Ileus, intestinal obstruction, megacolon
- Poorly controlled hypertension (HTAS> 180 HTAD> 100)
- Terminal renal failure (pre-dialysis or dialysis)
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 |
|---|---|---|
| One-day Low fiber dietOne-day low fiber diet before colonoscopy | Other | One-day low fiber diet |
| Three-day low fiber dietThree days low fiber diet before colonoscopy | Other | Three-day low fiber diet |
| Polyethylene Glycol plus ascorbic acid2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups | Drug | One-day low fiber diet, Three-day low fiber diet |
Primary outcome
Boston Bowel Preparation Scale
Time frame: 7 months
This scale goes from 0 (no preparation) to 3 points (excellent preparation) in the three segments of the colon (Proximal, transverse and distal). Maximum punctuation is 9 points
2 secondary outcomes
Proportion of polyps detected in each arm
Time frame: 7 months
Degree of satisfaction with diet
Time frame: 7 months
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 Aug 2018.
- Results publication: PubMed 23335011Hassan C, Bretthauer M, Kaminski MF, Polkowski M, Rembacken B, Saunders B, Benamouzig R, Holme O, Green S, Kuiper T, Marmo R, Omar M, Petruzziello L, Spada C, Zullo A, Dumonceau JM; European Society of Gastrointestinal Endoscopy. Bowel preparation for colonoscopy: European Society of Gastrointestinal Endoscopy (ESGE) guideline. Endoscopy. 2013;45(2):142-50. doi: 10.1055/s-0032-1326186. Epub 2013 Jan 18.
- Results publication: PubMed 26735547Song GM, Tian X, Ma L, Yi LJ, Shuai T, Zeng Z, Zeng XT. Regime for Bowel Preparation in Patients Scheduled to Colonoscopy: Low-Residue Diet or Clear Liquid Diet? Evidence From Systematic Review With Power Analysis. Medicine (Baltimore). 2016 Jan;95(1):e2432. doi: 10.1097/MD.0000000000002432.
- Results publication: PubMed 28282690Gimeno-Garcia AZ, Baute JL, Hernandez G, Morales D, Gonzalez-Perez CD, Nicolas-Perez D, Alarcon-Fernandez O, Jimenez A, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Carrillo M, Ramos L, Quintero E. Risk factors for inadequate bowel preparation: a validated predictive score. Endoscopy. 2017 Jun;49(6):536-543. doi: 10.1055/s-0043-101683. Epub 2017 Mar 10.
- Results publication: PubMed 21160321Wu KL, Rayner CK, Chuah SK, Chiu KW, Lu CC, Chiu YC. Impact of low-residue diet on bowel preparation for colonoscopy. Dis Colon Rectum. 2011 Jan;54(1):107-12. doi: 10.1007/DCR.0b013e3181fb1e52.
- Derived from this study: PubMed 30943553Gimeno-Garcia AZ, de la Barreda Heuser R, Reygosa C, Hernandez A, Mascareno I, Nicolas-Perez D, Jimenez A, Lara AJ, Alarcon-Fernandez O, Hernandez-Guerra M, Romero R, Alonso I, Gonzalez Y, Adrian Z, Hernandez G, Hernandez D, Delgado R, Quintero E. Impact of a 1-day versus 3-day low-residue diet on bowel cleansing quality before colonoscopy: a randomized controlled trial. Endoscopy. 2019 Jul;51(7):628-636. doi: 10.1055/a-0864-1942. Epub 2019 Apr 3.
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.
Enrique Quintero, MD, PhD study director
Hospital Universitario de Canarias
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One-day Low fiber diet, Three-day low fiber diet and Polyethylene Glycol plus ascorbic acid in people with Cleansing Quality of the Colon, run by Hospital Universitario de Canarias 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 14 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 Aug 2018. 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?
Boston Bowel Preparation Scale (time frame: 7 months). 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 NCT03247452, which also lists 5 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 Aug 2018.