The Effect of Chewing Gum on Small Bowel Transit Time

NCT ID: NCT01241825

Last Updated: 2014-09-30

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

122 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-09-30

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to see if chewing sugarless chewing gum alters the time it takes for a capsule endoscopy to travel through the stomach and small bowel, and to see if more/less capsule endoscopes reach the large bowel.

Detailed Description

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The subjects will include patients already referred to us for a capsule endoscopy (CE) in this unit. We have calculated how many patients we need from small bowel transit times from the last 100 patients who had a CE at our centre. We will include 122. These will be randomly divided into two groups. The patients (chew chewing gum) and the controls (do not chew chewing gum).

Conditions

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Bowel Transit Times

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Participants

Study Groups

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1.

The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy.

Group Type ACTIVE_COMPARATOR

Trident sugarless chewing gum.

Intervention Type OTHER

Patients will be randomly divided into 2 groups, one subject group (these chew gum) and one control group (these do not chew gum). The subjects will have to chew Trident sugarless chewing gum for 20-30 minutes every 2 hours, all together 4 times at t=0 h, t=2, t=4 and t=6 h.

2.

The control group will not chew chewing gum while undergoing capsule endoscopy.

Group Type PLACEBO_COMPARATOR

One control group (these do not chew gum).

Intervention Type OTHER

The control group will not chew chewing gum while undergoing capsule endoscopy

Interventions

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Trident sugarless chewing gum.

Patients will be randomly divided into 2 groups, one subject group (these chew gum) and one control group (these do not chew gum). The subjects will have to chew Trident sugarless chewing gum for 20-30 minutes every 2 hours, all together 4 times at t=0 h, t=2, t=4 and t=6 h.

Intervention Type OTHER

One control group (these do not chew gum).

The control group will not chew chewing gum while undergoing capsule endoscopy

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* All out-patients \> 19 years old presenting for capsule endoscopy

Exclusion Criteria

* Patients on narcotics
* Patients on motility enhancing and/or slowing drugs should stop these at least 5 days prior to the procedure or be excluded from the study.
* Patients, who have proven or suspected obstruction of the bowel.
* Patients, who have had prior small bowel and/or gastric surgery.
* Patients with an ileostomy.
* Patients who have a known and/or have a history of swallowing disorder
* Patients with diabetes and/or hypo-/hyper- thyroidism
* Patients in whom the capsule become impacted at a stricture (these patients will be taken out of the study and given the necessary medical/surgical treatment).
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robert A. Enns, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Eric Lam, Dr.

Role: STUDY_DIRECTOR

University of British Columbia

Jennifer Telford, Dr.

Role: STUDY_DIRECTOR

University of British Columbia

Locations

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St. Paul's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 24112594 (View on PubMed)

Other Identifiers

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H10-01726

Identifier Type: -

Identifier Source: org_study_id

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