a Low-residue Diet for Bowel Preparation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

589 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-10

Study Completion Date

2020-12-31

Brief Summary

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Previous researches demonstrated that a prepackaged low-residue diet (LRD) could achieve better bowel preparation quality compared with a self-prepared LRD. However, up to now, there has been no widely acceptable standard of LRD for bowel preparation. Moreover, these prepackaged LRD adopted in previous studies mainly consisted of traditional foods without further processing. Recently, a prepackaged LRD for Special Medical Purpose was specifically designed for bowel preparation. This trail was to compare the impact of the prepackaged LRD on bowel preparation for colonoscopy with self-prepared LRD by patients.

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Detailed Description

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Conditions

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Colon Polyp Colorectal Adenoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

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prepackaged Low-residue diet group

The prepackaged Low-residue diet (Maifu Nutrition Technology Co. Ltd, Beijing, China). One package of the prepackaged Low-residue diet contained quantity of heat amounts to 268 kilocalories with 12.0 g of protein, 9.6 g of lipid, and 34.1 g of carbohydrate.

Group Type EXPERIMENTAL

Prepackaged Low-residue diet

Intervention Type DIETARY_SUPPLEMENT

Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.

self-prepared Low-residue group

Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy

Group Type ACTIVE_COMPARATOR

Self-prepared Low-residue diet

Intervention Type DIETARY_SUPPLEMENT

Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.

Interventions

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Prepackaged Low-residue diet

Subjects in the prepackaged Low-residue diet group were given 6 packs (60g/pack) pre-packaged formula LRD and asked to use the formula according to individual needs prior to colonoscopy.

Intervention Type DIETARY_SUPPLEMENT

Self-prepared Low-residue diet

Subjects in the self-prepared Low-residue diet group were instructed to follow and prepare an Low-residue diet in the day prior to colonoscopy.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients whose age is between 18-65.
* Patients who have indications for screening, surveillance and diagnostic colonoscopy.
* Patients who have signed inform consent form

Exclusion Criteria

* subjects who had known or suspected heart failure, stroke or renal failure;
* subjects who had a history of colon surgery or inflammatory bowel disease;
* subjects who Patients with had digestion or absorption dysfunction or any dietary restriction due to various reasons;
* subjects who had a history of hypersensitivity to any ingredients of laxatives or soy products;
* subjects who had high risk factors for bowel preparation such as chronic constipation, Body Mass Index (BMI) greater than 30 or BMI less than 18 Kg/m2, diabetes, spinal cord injury, or use of medications affecting bowel motility within a week;
* subjects who had participated in another interventional clinical trial in the previous 60 days;
* pregnant or lactating women and those planning to become pregnant.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No