Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial

June 1, 2020 updated by: The Guthrie Clinic
This is a randomized, three-arm, double-blind, placebo-controlled, Phase III clinical trial of caffeinated gum and sugar-less gum in adult patients after an abdominal procedure. Patients will be randomized to receive placebo, sugar-less gum or caffeinated gum three times daily for 30 minutes starting the day following surgery until discharge or 24 hours after attainment of the primary endpoint.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • The Guthrie Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.

Exclusion Criteria:

  • ASA physical status score of >3, GCS < 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Behavioral: wear silicone bracelet
Subjects will put on bracelet to correspond with times for chewing gum
Sham Comparator: Sugar-less Gum
Subjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Other: Gum
Chewing gum
Experimental: Caffeinated Gum
Subjects will chew one stick of caffeinated gum (100mg caffeine per stick) for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.
Other: Gum
Chewing gum
Dietary supplement: Caffeine
caffeinated gum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mean time to GI function recovery (GI-3)
Time Frame: An expected average of 5 days
An expected average of 5 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Mean length of postoperative hospitalization
Time Frame: Up to 30 days
Up to 30 days
Rate of postoperative ileus
Time Frame: Up to 30 days
Up to 30 days
Adverse event rates
Time Frame: Up to 30 days postoperative
Up to 30 days postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Guthrie Clinic

Investigators

  • Principal Investigator: Karim Sadik, MD, The Guthrie Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

January 1, 2017

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

May 28, 2020

Study Registration Dates

First Submitted

September 22, 2014

First Submitted That Met QC Criteria

September 24, 2014

First Posted (Estimate)

September 26, 2014

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 1, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GC1410-55

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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