Bowel Transit TimesNCT01241825
The Effect of Chewing Gum on Small Bowel Transit Time
A study testing Trident sugarless chewing gum. in people with Bowel Transit Times, run by University of British Columbia at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Bowel Transit Times
- What is being tested?
- Trident sugarless chewing gum.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2010to Jul 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All out-patients > 19 years old presenting for capsule endoscopy
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
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.
Read the detailed description
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
- Bowel Transit Times
- Being tested
- Trident sugarless chewing gum., One control group (these do not chew gum).
- Keywords
- capsule endoscopy, chewing gum, small bowel transit time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trident sugarless chewing gum.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.
One control group (these do not chew gum).Other
The control group will not chew chewing gum while undergoing capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| 1. | Active comparator | The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Receives: Other: Trident sugarless chewing gum. |
| 2. | Placebo comparator | The control group will not chew chewing gum while undergoing capsule endoscopy. Receives: Other: One control group (these do not chew gum). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Small bowel transit time
Measured: 6 hours
Secondary outcomes (1)
Gastric transit time, cecal completion rate
Measured: 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionJul 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel Transit TimesStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert A. Enns, Dr., Principal investigator, University of British ColumbiaEric Lam, Dr., Study director, University of British ColumbiaJennifer Telford, Dr., Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01241825
- Sponsor's protocol ID
- H10-01726
- Status last verified
- Sep 2014
- First submitted
- 12 Nov 2010
- Last updated
- 30 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24112594
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Chewing Gum on Small Bowel Transit Time: a Prospective Randomized Trial.
- ClinicalTrials.gov ID
- NCT01241825
- Acronym / sponsor ID
- H10-01726
- Conditions
- Bowel Transit Times
- Keywords
- capsule endoscopy, chewing gum, small bowel transit time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. | Active comparator | Other: Trident sugarless chewing gum.The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. |
| 2. | Placebo comparator | Other: One control group (these do not chew gum).The control group will not chew chewing gum while undergoing capsule endoscopy. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All out-patients > 19 years old presenting for capsule endoscopy
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | 1. |
| One control group (these do not chew gum).The control group will not chew chewing gum while undergoing capsule endoscopy | Other | 2. |
Primary outcome
Small bowel transit time
Time frame: 6 hours
1 secondary outcome
Gastric transit time, cecal completion rate
Time frame: 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2014.
- Derived from this study: PubMed 24112594Ou 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert A. Enns, Dr. principal investigator
University of British Columbia
Eric Lam, Dr. study director
University of British Columbia
Jennifer Telford, Dr. study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trident sugarless chewing gum. in people with Bowel Transit Times, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Small bowel transit time (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01241825, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2014.