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

NCT02250924 | Withdrawn

• 1 other identifier: GC1410-55
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

C.Surgical Procedure; Digestive System

Outcome Measures

Primary Outcomes (1)

• Mean time to GI function recovery (GI-3)

  An expected average of 5 days

Secondary Outcomes (3)

• Mean length of postoperative hospitalization

  Up to 30 days

• Rate of postoperative ileus

  Up to 30 days

• Adverse event rates

  Up to 30 days postoperative

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm.

Behavioral: wear silicone bracelet

Sugar-less Gum

SHAM COMPARATOR

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

Caffeinated Gum

EXPERIMENTAL

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; Other: Gum

Interventions

Caffeine DIETARY_SUPPLEMENT

caffeinated gum

Caffeinated Gum

Gum OTHER

Chewing gum

Caffeinated Gum; Sugar-less Gum

wear silicone bracelet BEHAVIORAL

Subjects will put on bracelet to correspond with times for chewing gum

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Guthrie Clinic: lead

Study Sites (1)

The Guthrie Clinic

Sayre, Pennsylvania, 18840, United States

Location

MeSH Terms

Interventions

Caffeine; Chewing Gum

Intervention Hierarchy (Ancestors)

Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Karim Sadik, MD

  The Guthrie Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 26, 2014
• Study Start: January 1, 2017
• Primary Completion: May 1, 2020
• Study Completion: May 28, 2020
• Last Updated: June 4, 2020

Record last verified: 2020-06

Locations

US (1)