None listed
Conditions
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.
Interventions
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 diseas
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.
Sponsors
University of Otago
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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
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
Outcome results
None listed