NCT02507037

Brief Summary

In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 150) used 2 L PEG before colonoscopy. Patients in group B (n = 150) were additionally advised to chew sugarless gum plus 2 L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by endoscopists who was blinded to the intervention. Difficulty of procedure, patients' tolerance, and adverse events were also evaluated.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jul 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 19, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 23, 2015

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

March 18, 2016

Status Verified

March 1, 2016

Enrollment Period

1.1 years

First QC Date

July 19, 2015

Last Update Submit

March 17, 2016

Conditions

Bowel Preparation ScaleAdenoma Detection Rate

Outcome Measures

Primary Outcomes (1)

  • Boston Bowel Preparation Scale

    2 days

Secondary Outcomes (3)

  • number of patient tolerability

    2 days

  • number of patient willingness to repeat preparation

    2 days

  • Adenoma Detection Rate

    2 days

Study Arms (2)

gum+PEG

EXPERIMENTAL

used 2L PEG+sugarless gum

Dietary Supplement: gum+PEG

PEG

PLACEBO COMPARATOR

only used 2L PEG

Drug: polyethylene glycol

Interventions

gum+PEGDIETARY_SUPPLEMENT

chew sugarless gum

gum+PEG
polyethylene glycolDRUG

2L PEG

PEG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All adults (18-65) who were referred for outpatient colonoscopy.

You may not qualify if:

  • under 18 years or More than 65 years
  • previous abdominal surgery
  • major psychiatric disorders
  • pregnancy
  • presence of any contraindications for colonoscopy(eg, severe heart failure)
  • recent inadequate colonoscopy history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Sakin YS, Uygun A, Bagci S. Comment on: Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2015 Jan-Feb;21(1):56. doi: 10.4103/1319-3767.151233. No abstract available.

    PMID: 25672242RESULT

  • Ergul B, Filik L, Kocak E, Dogan Z, Sarikaya M. Efficacy and safety of gum chewing in adjunct to high-dose senna for bowel cleansing before colonoscopy: a single-blind randomized controlled trial. Saudi J Gastroenterol. 2014 Nov-Dec;20(6):356-9. doi: 10.4103/1319-3767.145325.

    PMID: 25434316RESULT

  • Ou G, Svarta S, Chan C, Galorport C, Qian H, Enns R. The effect of chewing gum on small-bowel transit time in capsule endoscopy: a prospective, randomized trial. Gastrointest Endosc. 2014 Apr;79(4):630-6. doi: 10.1016/j.gie.2013.08.038. Epub 2013 Oct 7.

    PMID: 24112594RESULT

  • Fang J, Wang SL, Fu HY, Li ZS, Bai Y. Impact of gum chewing on the quality of bowel preparation for colonoscopy: an endoscopist-blinded, randomized controlled trial. Gastrointest Endosc. 2017 Jul;86(1):187-191. doi: 10.1016/j.gie.2016.05.051. Epub 2016 Jun 17.

    PMID: 27327849DERIVED

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene GlycolsGlycolsAlcoholsOrganic ChemicalsPolymersMacromolecular SubstancesBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept.

Study Record Dates

First Submitted

July 19, 2015

First Posted

July 23, 2015

Study Start

July 1, 2014

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

March 18, 2016

Record last verified: 2016-03