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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02250924
Recruitment Status : Withdrawn (Investigator decision - clinical practice change)
First Posted : September 26, 2014
Last Update Posted : June 4, 2020
Sponsor:
Information provided by (Responsible Party):
The Guthrie Clinic

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
C.Surgical Procedure; Digestive System Dietary Supplement: Caffeine Other: Gum Behavioral: wear silicone bracelet Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
Estimated Study Start Date : January 2017
Actual Primary Completion Date : May 2020
Actual Study Completion Date : May 28, 2020

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.
Dietary Supplement: Caffeine
caffeinated gum

Other: Gum
Chewing gum




Primary Outcome Measures :
  1. Mean time to GI function recovery (GI-3) [ Time Frame: An expected average of 5 days ]

Secondary Outcome Measures :
  1. Mean length of postoperative hospitalization [ Time Frame: Up to 30 days ]
  2. Rate of postoperative ileus [ Time Frame: Up to 30 days ]
  3. Adverse event rates [ Time Frame: Up to 30 days postoperative ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02250924


Locations
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United States, Pennsylvania
The Guthrie Clinic
Sayre, Pennsylvania, United States, 18840
Sponsors and Collaborators
The Guthrie Clinic
Investigators
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Principal Investigator: Karim Sadik, MD The Guthrie Clinic
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Responsible Party: The Guthrie Clinic
ClinicalTrials.gov Identifier: NCT02250924    
Other Study ID Numbers: GC1410-55
First Posted: September 26, 2014    Key Record Dates
Last Update Posted: June 4, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents