C.Surgical Procedure; Digestive SystemNCT02250924
Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
A study testing Caffeine, Gum and wear silicone bracelet in people with C.Surgical Procedure; Digestive System, run by The Guthrie Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- C.Surgical Procedure; Digestive System
- What is being tested?
- Caffeine, Gum and wear silicone bracelet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to 28 May 2020
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.
Who cannot join
- ASA physical status score of >3, GCS < 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Caffeine, Gum, wear silicone bracelet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CaffeineDietary supplement
caffeinated gum
GumOther
Chewing gum
wear silicone braceletBehavioural
Subjects will put on bracelet to correspond with times for chewing gum
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. Receives: 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. Receives: 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. Receives: Dietary Supplement: Caffeine; Other: Gum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean time to GI function recovery (GI-3)
Measured: An expected average of 5 days
Secondary outcomes (3)
Mean length of postoperative hospitalization
Measured: Up to 30 days
Rate of postoperative ileus
Measured: Up to 30 days
Adverse event rates
Measured: Up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2014 (estimated)
- Study startJan 2017 (estimated)
- Primary completionMay 2020
- Study completion28 May 2020
Why it stopped: Investigator decision - clinical practice change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for C.Surgical Procedure; Digestive SystemStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Guthrie Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karim Sadik, MD, Principal investigator, The Guthrie Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02250924
- Sponsor's protocol ID
- GC1410-55
- Status last verified
- Jun 2020
- First submitted
- 22 Sep 2014
- Last updated
- 4 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Caffeinated Gum to Prevent Post-Operative Ileus: A Prospective, Randomized, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT02250924
- Acronym / sponsor ID
- GC1410-55
- Conditions
- C.Surgical Procedure; Digestive System
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decision - clinical practice change
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Guthrie ClinicUniversity, hospital or other
- Study start
- Jan 2017 (estimated)
- Primary completion
- May 2020 (actual)
- Study completion
- 28 May 2020 (actual)
- First posted
- 26 Sep 2014 (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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Behavioral: wear silicone braceletSubjects will wear a silicone bracelet for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. |
| Sugar-less Gum | Sham comparator | Other: GumSubjects will chew one stick of sugar-less gum for 30 minutes 3 times daily at 8 am, 12 pm and 4 pm. |
| Caffeinated Gum | Experimental | Dietary Supplement: Caffeine, Other: GumSubjects 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Abdominal procedure (Laparoscopic or open, occurring electively), American Society of Anesthesiologists (ASA) physical status score ≤ 3, Glasgow Coma Score (GCS) ≥ 15.
Key exclusion criteria (1 listed)
- ASA physical status score of >3, GCS < 15, complete bowel obstruction, history of cardiac arrhythmia, history of phenylketonuria, alcohol abuse. substance abuse dentures
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 |
|---|---|---|
| Caffeinecaffeinated gum | Dietary supplement | Caffeinated Gum |
| GumChewing gum | Other | Caffeinated Gum, Sugar-less Gum |
| wear silicone braceletSubjects will put on bracelet to correspond with times for chewing gum | Behavioural | Placebo |
Primary outcome
Mean time to GI function recovery (GI-3)
Time frame: An expected average of 5 days
3 secondary outcomes
Mean length of postoperative hospitalization
Time frame: Up to 30 days
Rate of postoperative ileus
Time frame: Up to 30 days
Adverse event rates
Time frame: Up to 30 days postoperative
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2020.
Related trials for C.Surgical Procedure; Digestive System
Recruiting
Use of Stratafix Symmetric™ to Prevent Incisional Hernia in Gastrointestinal and Abdominal Surgery
C.Surgical Procedure; Disruption of Wound, Suture
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.
Karim Sadik, MD principal investigator
The Guthrie Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine, Gum and wear silicone bracelet in people with C.Surgical Procedure; Digestive System, run by The Guthrie Clinic at 1 site in United States.
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 1 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: withdrawn, as of the sponsor's last update on 4 Jun 2020. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Mean time to GI function recovery (GI-3) (time frame: An expected average of 5 days). 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 4 Jun 2020.