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Impact of Low Fiber Diet on Colonic Cleansing Quality (DIETPREP)

Impact of Low Fiber Diet on Colonic Cleansing Quality Prior to Colonoscopy: Randomized Study Comparing 1 Day Versus 3 Days of Low Fiber Diet

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03247452
Acronym
DIETPREP
Enrollment
404
Registered
2017-08-11
Start date
2017-12-18
Completion date
2018-07-01
Last updated
2018-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cleansing Quality of the Colon

Keywords

Low fiber diet, Colonoscopy, Bowel Cleansing

Brief 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. 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.

Interventions

OTHEROne-day Low fiber diet

One-day low fiber diet before colonoscopy

OTHERThree-day low fiber diet

Three days low fiber diet before colonoscopy

2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups

Sponsors

Hospital Universitario de Canarias
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)

Masking description

Only the endoscopists in charged of rating cleansing quality during colonoscopy will be masked.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Age ≥ 18 years

Exclusion criteria

* 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) * 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

Design outcomes

Primary

MeasureTime frameDescription
Boston Bowel Preparation Scale7 monthsThis 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

Secondary

MeasureTime frameDescription
Proportion of polyps detected in each arm7 monthsNumber of polyps detected in one arm/total of polyps detected
Degree of satisfaction with diet7 monthsIt will be assessed using a visual scale (1 excellent to 10 unbearable)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026