Gastric Transit TimeCGCENCT03815136
The Effectiveness of Chewing Gum in Influencing Capsule Endoscopy Transit Time
A study testing Chewing Gum in people with Gastric Transit Time and Small-bowel Transit Time, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
Trial summary
The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Gastric Transit Time, Small-bowel Transit Time
- What is being tested?
- Chewing Gum
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 20 Jan 2019to 31 Jul 2019
- 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients aged ≥18 years and <80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.
Who cannot join
- Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure.
- Patients, who have proven or suspected obstruction of the bowel.
- Patients, who have had prior small bowel and/or gastric surgery.
- Patients, who have a dysphagia prohibiting.
- Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.
Trial locations and contacts
1 site in 1 country.
China1 site
First Affiliated Hospital of Zhejiang Chinese Medical University
Hangzhou, Zhejiang, 310006
About this study
Official title: The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study
The purpose of this study is to determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.
Read the detailed description
The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).
- Conditions
- Gastric Transit Time, Small-bowel Transit Time
- Being tested
- Chewing Gum, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chewing GumOther
Patients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination.
ControlOther
The control group will not chew chewing gum while undergoing capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| Chewing Gum | Active comparator | The subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination. Receives: Other: Chewing Gum |
| Control | Placebo comparator | The control group will not chew chewing gum while undergoing capsule endoscopy. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastric transit time
the time interval between the first gastric image and the first duodenal image
Measured: 1 hour
small bowel transit time
The time interval between the first duodenal images and the first caecal image
Measured: 8 hour
Secondary outcomes (3)
Completion rate
the capsule reaching the caecum
Measured: 9 hours
Diagnostic yield
the total number of positive (diagnostic and suspicious) findings
Measured: 9 hours
Intervention rate
Gastroscopy intervention after capsule endoscopy not through pylorus within 1hour
Measured: 1 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start20 Jan 2019
- Primary completion30 Jun 2019
- Study completion31 Jul 2019
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 Gastric Transit TimeStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bin Lv, M.D., Principal investigator, First Affiliated Hospital of Zhejiang Chinese Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815136
- Sponsor's protocol ID
- CG-HuY-1901
- Acronym
- CGCE
- Status last verified
- May 2020
- First submitted
- 20 Jan 2019
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data sharing will be consider after study
Publications
Huang L, Hu Y, Chen F, Liu S, Lu B. Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study. Front Med (Lausanne). 2021 Feb 15;8:605393. doi: 10.3389/fmed.2021.605393. eCollection 2021.
PubMed 33681244
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Improved Use of Chewing Gum in Influencing Capsule Endoscopy Transit Time: A Prospective Randomized, Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT03815136
- Acronym / sponsor ID
- CGCE / CG-HuY-1901
- Conditions
- Gastric Transit Time, Small-bowel Transit Time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Zhejiang Chinese Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2019 (actual)
- Primary completion
- 30 Jun 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 24 Jan 2019 (actual)
- 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 determine the effect of chewing gum, during the first one hour of examination in patients undergoing CE for GTT and SBTT time and the proportion of cases with complete small bowel examination and gastroscopy intervention.
Detailed description
The participants will include patients who need to a capsule endoscopy (CE) in this unit. The investigators will include 200 participants who had a CE at our centre based on the gastric transit times. These will be randomly divided into two groups. The participants (chew chewing gum) and the controls (do not chew chewing gum).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients aged 16-80 years who were scheduled to undergo the small bowel capsule endoscopy(SBCE).
| Arm | Type | Receives |
|---|---|---|
| Chewing Gum | Active comparator | Other: Chewing GumThe subject group will chew sugarless chewing gum for a specific amount of time while undergoing capsule endoscopy. Subjects chewed one piece of gum for approximately 15 min every 30 min at the first hour of the examination. |
| Control | Placebo comparator | Other: ControlThe control group will not chew chewing gum while undergoing capsule endoscopy. |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged ≥18 years and <80 years old presenting for capsule endoscopy. Obtained of written informed consent before the procedure.
Key exclusion criteria (5 listed)
- Patients on motility enhancing and/or slowing drugs(narcotics/prokinetics) should stop these at least 7 days prior to the procedure.
- Patients, who have proven or suspected obstruction of the bowel.
- Patients, who have had prior small bowel and/or gastric surgery.
- Patients, who have a dysphagia prohibiting.
- Patients with diabetes mellitus and/or hypo-/hyper-thyroidism.
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 |
|---|---|---|
| Chewing GumPatients of CG group chewed one piece of sugarless gum for approximately 15 min every 30 min at the first hour of the examination. | Other | Chewing Gum |
| ControlThe control group will not chew chewing gum while undergoing capsule endoscopy | Other | Control |
Primary outcome
gastric transit time
Time frame: 1 hour
the time interval between the first gastric image and the first duodenal image
small bowel transit time
Time frame: 8 hour
The time interval between the first duodenal images and the first caecal image
3 secondary outcomes
Completion rate
Time frame: 9 hours
Diagnostic yield
Time frame: 9 hours
Intervention rate
Time frame: 1 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 15 May 2020.
- Derived from this study: PubMed 33681244Huang L, Hu Y, Chen F, Liu S, Lu B. Effectiveness of Improved Use of Chewing Gum During Capsule Endoscopy in Decreasing Gastric Transit Time: A Prospective Randomized Controlled Study. Front Med (Lausanne). 2021 Feb 15;8:605393. doi: 10.3389/fmed.2021.605393. eCollection 2021.
- Individual participant dataSharing planned: Undecided. Individual participant data sharing will be consider after study
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.
Bin Lv, M.D. principal investigator
First Affiliated Hospital of Zhejiang Chinese Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chewing Gum in people with Gastric Transit Time and Small-bowel Transit Time, run by The First Affiliated Hospital of Zhejiang Chinese Medical University at 1 site in China.
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 5 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 15 May 2020. 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 China. 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?
gastric transit time (time frame: 1 hour). The study lists 2 primary outcomes in all. 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 NCT03815136, 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 15 May 2020.