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Completed

NCT Number: NCT03943758

a Low-residue Diet for Bowel Preparation

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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Key information

Conditions

Colon Polyp Adenoma Colonic Polyps Colorectal Adenoma Intestinal Polyps Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Prepackaged Low-residue diet

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 diet

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.

Primary outcomes

  1. Adequate bowel preparation rate

    Time frame: 30 mins

    Boston Bowel Preparation Scale (BBPS) was adopted to evaluate the quality of bowel preparation. Each section of the colon (i.e. the right, the transverse, and the rectosigmoid colon) was rated (0, very poor; 1, poor; 2, good; and 3, very good). Adequate bowel of bowel preparation was defined as a total score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.

  2. BBPS scores of the entire colon

    Time frame: 30 mins

    The sum of the scores of three bowel segment.

Secondary outcomes

  1. adenoma detection rate (ADR)

    Time frame: 30 mins

    adenoma detection rate is the number of patients with at least one adenoma, divided by the total number of patients.

  2. preparation completion rate

    Time frame: 1 day

    preparation completion rate is the number of patients ingest more than 80% laxative, divided by the total number of patients.

Sponsors and collaborators

Lead sponsor

Changhai Hospital

Other

Collaborators

  • First Affiliated Hospital, Sun Yat-Sen University
  • Jinan Military General Hospital
  • Qilu Hospital of Shandong University
  • The First Affiliated Hospital with Nanjing Medical University
  • West China Hospital
  • Wuhan TongJi Hospital
  • Zhejiang University

Registry information

Official study title

Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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