Paralytic IleusPhase 2/3GUM01NCT01131416
The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section
A Phase 2/3 study testing Gum chewing in people with Paralytic Ileus, run by Chiang Mai University at 1 site in Thailand.
Trial summary
Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Read more about this study
- Who is it for?
- Ages 15 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Paralytic Ileus
- What is being tested?
- Gum chewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteThailand
- Study dates
- May 2010to Jun 2011
- Phase
- Phase 2/3
- 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 15 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Pregnant women undergoing cesarean delivery
Who cannot join
- Perioperative hyperalimentation
- Recent chemotherapy
- Concurrent bowel surgery
- Previous bowel surgery
- Concurrent bowel obstruction
- History of inflammatory bowel diseases
Show all 9Show fewer
- Previous abdominal/pelvic radiation
- Postoperative placement of endotracheal tube/nasogastric tube
- Postoperative admission to intensive care unit
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine, Chiang Mai University
Chiang Mai, Chiang Mai, 50200
About this study
Official title: The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial
Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.
- Conditions
- Paralytic Ileus
- Being tested
- Gum chewing
- Medical subject headings
- Intestinal Pseudo-Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gum chewingBehavioural
Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule
| Study group | Role | What they receive |
|---|---|---|
| Gum chewing | Experimental | Gum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule Receives: Behavioral: Gum chewing |
| Conventional | No intervention | Conventional postoperative feeding schedule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative interval until the first flatus
Measured: Up to 7 days after delivery
Secondary outcomes (5)
Postoperative interval until the first passage of stool
Measured: Up to 7 days after delivery
Clinically significant postoperative ileus
Measured: Up to 7 days after delivery
Postoperative hospital stay
Measured: Up to 7 days after delivery
Related complications
Measured: Up to 7 days after delivery
Patients' satisfaction
Measured: Up to 7 days after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2010 (estimated)
- Study startMay 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paralytic IleusStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chiang Mai University
- Sponsor type
- University, hospital or other
- Investigators
- Kittipat Charoenkwan, MD, Principal investigator, Faculty of Medicine, Chiang Mai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01131416
- Sponsor's protocol ID
- 10FEB010938
- Acronym
- GUM01
- Status last verified
- Jun 2011
- First submitted
- 25 May 2010
- Last updated
- 28 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Gum Chewing on Bowel Function Recovery Following Cesarean Section: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01131416
- Acronym / sponsor ID
- GUM01 / 10FEB010938
- Conditions
- Paralytic Ileus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Chiang Mai UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 May 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.
Following all abdominal surgery, paralytic ileus commonly develops. Surgeons have traditionally withheld postoperative oral intake until the return of bowel function to prevent related complications. Gum chewing can stimulates bowel movement and promotes the return of bowel function through the cephalic-vagal reflex and increased intestinal enzymes secretion.
The objectives of this study are to examine effects of adding gum chewing to the conventional postoperative feeding regimen on the return of bowel function, its related complications, and patients' satisfaction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gum chewing | Experimental | Behavioral: Gum chewingGum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule |
| Conventional | No intervention | –Conventional postoperative feeding schedule |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Pregnant women undergoing cesarean delivery
Key exclusion criteria (9 listed)
- Perioperative hyperalimentation
- Recent chemotherapy
- Concurrent bowel surgery
- Previous bowel surgery
- Concurrent bowel obstruction
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 |
|---|---|---|
| Gum chewingGum chewing (30 minutes in duration each time, 4 times/days at the usual time of meal, until the first flatus) in addition to conventional postoperative feeding schedule | Behavioural | Gum chewing |
Primary outcome
Postoperative interval until the first flatus
Time frame: Up to 7 days after delivery
5 secondary outcomes
Postoperative interval until the first passage of stool
Time frame: Up to 7 days after delivery
Clinically significant postoperative ileus
Time frame: Up to 7 days after delivery
Postoperative hospital stay
Time frame: Up to 7 days after delivery
Related complications
Time frame: Up to 7 days after delivery
Patients' satisfaction
Time frame: Up to 7 days after delivery
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 28 Jun 2011.
Related trials for Paralytic Ileus
Not yet recruitingPhase 4
Effect of Preoperative Intrathecal Dexamethasone Versus Dexmedetomidine on Paralytic Ileus After Major Abdominal Surgery
Paralytic Ileus
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.
Kittipat Charoenkwan, MD principal investigator
Faculty of Medicine, Chiang Mai University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Gum chewing in people with Paralytic Ileus, run by Chiang Mai University at 1 site in Thailand.
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 9 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 28 Jun 2011. 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 Thailand. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative interval until the first flatus (time frame: Up to 7 days after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jun 2011; AzTrials last refreshed its copy on 7 Nov 2026.