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

August 14, 2018 updated by: Hospital Universitario de Canarias

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

404

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Department of Gastroenterology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: One-day low fiber diet

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
Other: One-day Low fiber diet
One-day low fiber diet before colonoscopy
Drug: Polyethylene Glycol plus ascorbic acid
2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
Experimental: Three-day low fiber diet

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
Drug: Polyethylene Glycol plus ascorbic acid
2 liters of Polyethylene Glycol plus ascorbic acid will be administered to both groups
Other: Three-day low fiber diet
Three days low fiber diet before colonoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of polyps detected in each arm
Time Frame: 7 months
Number of polyps detected in one arm/total of polyps detected
7 months
Degree of satisfaction with diet
Time Frame: 7 months
It will be assessed using a visual scale (1 excellent to 10 unbearable)
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario de Canarias

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

July 1, 2018

Study Registration Dates

First Submitted

August 9, 2017

First Submitted That Met QC Criteria

August 10, 2017

First Posted (Actual)

August 11, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2018

Last Update Submitted That Met QC Criteria

August 14, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Large bowel cleansing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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