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CompletedNCT02165436Updated Jun 17, 2014

Chewing Gum Facilitates an Earlier Return to Bowel Function in Pediatric Scoliosis Patients: A Prospective Randomized Study

An interventional study of Chewing gum and Control in Scoliosis, sponsored by University of Alabama at Birmingham. Completed at 1 site in United States. Open to participants aged 10 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-06-17.

Sponsored by University of Alabama at Birmingham · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
83
Allocation
Randomized
Ages
10 Years to 18 Years
Sex
All
01

Study summary

The purpose of this study is to evaluate the effectiveness of chewing gum on reducing post-operative ileus and reducing post-operative gastrointestinal symptoms in pediatric patients undergoing surgical correction of scoliosis. This study would provide minimal risk to its study population, and has the opportunity to provide a benefit to patients undergoing scoliosis surgery. If shown to be effective, this could lead to changes and improvement of the post-operative course for pediatric scoliosis patients.

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Conditions studied

  • Scoliosis

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03

In context

Scoliosis

594 studies on the registry are indexed under Scoliosis; 138 are open to participants now.

This study's enrollment of 83 is above the median of 44 across 344 interventional studies indexed under Scoliosis.

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Lead sponsor

University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.

Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
10 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Otherwise meets criteria for surgical correction of scoliosis
  • Mental capacity to understand the purpose of the study
  • Idiopathic scoliosis or neuromuscular scoliosis with mild cerebral involvement
  • Posterior surgery approach only

Exclusion criteria

Exclusion Criteria:

  • Unable to safely chew gum due to oropharyngeal issues or airway issues
  • History of GI surgery (G-tube, fundoplication, ostomy etc...)
  • Anterior approach
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
83 participants (actual)

Study arms

  • Placebo comparator
    Control

    No gum

    Other: Control

  • Active comparator
    Chewing Gum

    Bubble gum-flavored sugar-free gum - chew for 15-30 minutes 5 times/day

    Other: Chewing gum

Interventions

  • OtherChewing gum

    Subjective assessment - subjective assessment of abdominal pain and nausea.

  • OtherControl

    No intervention will be assessed for this group.

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What researchers measure

Primary outcomes

  1. Time to return of normal bowel function.

    Patients are interviewed daily as inpatient and then several days after surgery to determine the time (reported in hours post-operative) first flatus and first bowel movement was experienced.

    Time frame: 72-96 hours

07

Study locations

1 site
  • The Children's Hospital of Alabama
    Birmingham, Alabama 35233, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02165436
Lead sponsor
University of Alabama at Birmingham
Responsible party
Joseph G. Khoury, MD (Assistant Professor - Pediatric Orthopaedic Surgery, University of Alabama at Birmingham) — Principal investigator
First posted
Jun 17, 2014
Start date
Jul 2009
Primary completion
Jul 2013
Completion
Jul 2013
Last update
Jun 17, 2014

Study contacts

Joseph Khoury, MD
principal investigator · Pediatric Orthopaedic Surgery - University of Alabama At Birmingham

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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