Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

a Low-residue Diet for Bowel Preparation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03943758
Recruitment Status : Not yet recruiting
First Posted : May 9, 2019
Last Update Posted : May 16, 2019
Sponsor:
Collaborators:
Qilu Hospital of Shandong University
Jinan Military General Hospital
Wuhan TongJi Hospital
Zhejiang University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Information provided by (Responsible Party):
Zhaoshen Li, Changhai Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Colon Polyp Colorectal Adenoma Dietary Supplement: Prepackaged Low-residue diet Dietary Supplement: Self-prepared Low-residue diet Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Effect of a Prepackaged Low-residue Diet on Bowel Preparation for Colonoscopy
Estimated Study Start Date : May 10, 2019
Estimated Primary Completion Date : June 10, 2019
Estimated Study Completion Date : October 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Colonoscopy

Arm Intervention/treatment
Experimental: 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.
Dietary Supplement: Prepackaged Low-residue diet
Subjects in the prepackaged Low-residue diet group were given three packages of the prepackaged Low-residue diet, and instructed to ingest one package per meal without any other food being allowed in the day prior to colonoscopy.

Active Comparator: 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
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.




Primary Outcome Measures :
  1. Boston bowel preparation scale (BBPS) scores [ Time Frame: 30 mins ]
    BBPS was developed to evaluate the quality of colon preparation and was used in our previous study. 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 BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1.

  2. adequate bowel preparation rate [ Time Frame: 30 mins ]
    Adequate bowel of bowel preparation was defined as a total BBPS score ≥ 6 and all colon segments BBPS ≥ 2. Inadequate bowel preparation was defined as any colon segment BBPS ≤ 1


Secondary Outcome Measures :
  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 90% laxative, divided by the total number of patients.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients whose age is between 18-75.
  • Patients who have indications for screening, surveillance and diagnostic colonoscopy.
  • Patients who have signed inform consent form

Exclusion Criteria:

  • Patients who have undergone colonic resection
  • Patients with intracranial and/or central nervous system disease, including cerebral infarction and cerebral hemorrhage.
  • Patients with severe chronic cardiopulmonary and renal disease.
  • Patients who are unwilling or unable to consent.
  • Patients who are not suitable for colonoscopy
  • Patients who received urgent or therapeutic colonoscopy
  • Patients with pregnancy or breastfeeding, inflammatory bowel disease, polyposis of colon, BMI >30, colorectal cancer, diabetes mellitus, or intestinal obstruction
  • Patients who are taking aspirin, clopidogrel or other anticoagulants
  • Patients who are known allergies to any ingredients of the LRFP and polyethylene glycol-electrolyte lavage solution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03943758


Contacts
Layout table for location contacts
Contact: Zhaoshen Li, M.D. 86-21-31161365 li.zhaoshen@hotmail.com
Contact: Yu Bai, M.D. +86-21-31161335 baiyu1998@hotmail.com

Locations
Layout table for location information
China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital
Qilu Hospital of Shandong University
Jinan Military General Hospital
Wuhan TongJi Hospital
Zhejiang University
First Affiliated Hospital, Sun Yat-Sen University
The First Affiliated Hospital with Nanjing Medical University
West China Hospital
Investigators
Layout table for investigator information
Principal Investigator: Zhaoshen Li, M.D. Changhai Hospital

Layout table for additonal information
Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept, Changhai Hospital
ClinicalTrials.gov Identifier: NCT03943758     History of Changes
Other Study ID Numbers: Low-residue
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 16, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Zhaoshen Li, Changhai Hospital:
Bowel preparation
Polyp
adenoma

Additional relevant MeSH terms:
Layout table for MeSH terms
Adenoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms