Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000973819
Ethics application status
Approved
Date submitted
15/05/2012
Date registered
10/09/2012
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Gutsy Gum and Heartburn
Scientific title
A randomised placebo controlled crossover trial to compare the effects of gutsy gum and placebo gum on symptoms of Gastroesophogeal reflux disease (GERD) after the consumption of a refluxogenic meal.
Secondary ID [1] 280470 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroesophogeal reflux disease (GERD) 286445 0
Condition category
Condition code
Diet and Nutrition 286706 286706 0 0
Other diet and nutrition disorders
Oral and Gastrointestinal 286707 286707 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be a randomised, placebo-controlled, crossover study with two arms.
Arm 1: Gutsy Gum x 3 sticks.
Arm 2: Placebo Gum x 3 sticks.
This study will be carried out to assess the effects of consuming of a Gum containing (calcium carbonate (500mg per stick of gum) as well as three natural ingredients: licorice extract, papain and apple cider vinegar: each stick of gum contains 74.73mg of a blend of apple cider vinegar, licorice extract and papain) on symptoms of Gastroesophogeal reflux disease (GERD) following the ingestion of a refluxogenic meal (which consists of A Big Mac, Fries, Salsa, tabasco and Sprite, consumed over a 20 minute period). Participants will chew the gum for 30 minutes immediately following the consumption of the meal. Participants will be assigned in random order to receive the 2 treatments. There will be a 1-week washout between treatments.
Intervention code [1] 284833 0
Prevention
Intervention code [2] 284853 0
Treatment: Other
Comparator / control treatment
Placebo: Will receive a Gum without the calcium carbonate, licorice extract, papain and apple cider vinegar.
Control group
Placebo

Outcomes
Primary outcome [1] 287101 0
Primary Outcome 1: Perceived symptoms of reflux and heartburn. This will be measured using a Visual Analogue Scale (VAS).
Timepoint [1] 287101 0
Timepoint: at baseline, 15min, 30min, 45min, 60min, 75min, 90min,105min, 120min, 150min, 180min, 210min, 240min post-meal termination and the morning following meal ingestion.
Secondary outcome [1] 297376 0
Nil
Timepoint [1] 297376 0
Nil

Eligibility
Key inclusion criteria
Males and females aged greater than or equal to 18 years
People with > 2-year history of reflux symptoms and reflux symptoms relieved by antacids or anti-secretory agents
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
People with a chronic disease e.g. heart disease, diabetes
People with food allergies or intolerances
People using proton pump inhibitors such as omeprazole
People with a history of upper gastrointestinal surgery
People with a history of bleeding diathesis or coagulopathy
People who have suffered a stroke or transient ischemic attack
People with esophageal varices
People who are allergic to Papain or rubber latex

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment will be used. This will be achieved through allocation being performed by a research assistant who will have no involvement in the enrolment process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation will be performed using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
17/09/2012
Actual
17/09/2012
Date of last participant enrolment
Anticipated
Actual
8/10/2012
Date of last data collection
Anticipated
Actual
7/12/2012
Sample size
Target
20
Accrual to date
Final
24
Recruitment outside Australia
Country [1] 4299 0
New Zealand
State/province [1] 4299 0
Otago

Funding & Sponsors
Funding source category [1] 285243 0
Commercial sector/Industry
Name [1] 285243 0
Gutsy Gum LLC
Country [1] 285243 0
United States of America
Primary sponsor type
University
Name
University of Otago
Address
University of Otago
PO Box 56
Dunedin, 9054
New Zealand
Country
New Zealand
Secondary sponsor category [1] 284108 0
None
Name [1] 284108 0
Address [1] 284108 0
Country [1] 284108 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287253 0
University of Otago HUman Ethics Committee
Ethics committee address [1] 287253 0
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Ethics committee country [1] 287253 0
New Zealand
Date submitted for ethics approval [1] 287253 0
Approval date [1] 287253 0
10/05/2012
Ethics approval number [1] 287253 0
1/12/0083

Summary
Brief summary
Gastroesophogeal reflux disease (GERD) is a condition where the stomach contents move from the stomach to the esophagus. This results in heartburn, a painful burning sensation in the esophagus, as well as epigastric pain, discomfort and regurgitation. Dyspepsia or indigestion often accompanies GERD and is characterized by upper abdominal pain, belching, nausea and bloating. Up to 40% of the population is afflicted with GERD or dyspepsia at some point in their lives. One approach to manage this condition that has yielded promising results is chewing gum after a meal. A new gum has been developed (Gutsy Gum), which contains calcium carbonate as well as three natural ingredients, licorice extract, papain and apple cider vinegar, which may provide additional benefit for those suffering from GERD. We aim to determine whether Gutsy Gum is better than a placebo gum in alleviating the symptoms of GERD following a diet which should induce heartburn in subjects with a history GERD in a crossover trial.
Trial website
Trial related presentations / publications
Effect of GutsyGumtm, A Novel Gum, on Subjective Ratings of Gastro Esophageal Reflux Following A Refluxogenic Meal. Journal of Dietary Supplements, Early Online:1–8, 2014, DOI: 10.3109/19390211.2014.950783
Public notes

Contacts
Principal investigator
Name 34164 0
A/Prof Rachel Brown
Address 34164 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9052
Country 34164 0
New Zealand
Phone 34164 0
+64 3 4795839
Fax 34164 0
Email 34164 0
[email protected]
Contact person for public queries
Name 17411 0
A/Prof Rachel Brown
Address 17411 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 17411 0
New Zealand
Phone 17411 0
+64 3 4795839
Fax 17411 0
Email 17411 0
[email protected]
Contact person for scientific queries
Name 8339 0
A/Prof Rachel Brown
Address 8339 0
Department of Human Nutrition
University of Otago
PO Box 56
Dunedin 9054
New Zealand
Country 8339 0
New Zealand
Phone 8339 0
+64 3 4795839
Fax 8339 0
Email 8339 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseEffect of GutsyGum(tm), A Novel Gum, on Subjective Ratings of Gastro Esophageal Reflux Following A Refluxogenic Meal.2015https://dx.doi.org/10.3109/19390211.2014.950783
N.B. These documents automatically identified may not have been verified by the study sponsor.