Open-label Antacid-controlled Randomized Study on Effectiveness of Alginate-antacid Preparation (Gaviscon-Advance®) in Suppression of Post-supper Acid-pocket, Night-time Acid-reflux and Symptoms in Obese Participants
Alginate-antacid group
+ Non antacid alginate group
Body Weight+11
+ Deglutition Disorders
+ Digestive System Diseases
Treatment Study
Summary
Study start date: July 1, 2016
Actual date on which the first participant was enrolled.Gastroesophageal reflux disease (GERD) with symptoms of heartburn and acid regurgitation is a common disorder especially in overweight and obese persons who are at increased risk for GERD. Late night supper, an usual eating habit in many parts of the world, may worsen GERD and especially so among the obese, and this may be due to increased reflux from acid pocket. Acid pocket in the proximal part of stomach after meals has been shown to be an important mechanism of GERD. The acid pocket is increasingly recognized as a source from which acid reflux events originate. To what extent changes in acidity of the acid pocket contribute to the therapeutic effect of alginate antacid formulation is inconsistent. The other findings suggested that the main mechanism of action for the alginate-antacid combination is to displace the post-prandial acid pocket rather than mechanically containing it. Therefore, the outcomes of the study will allow us to determine whether late night supper worsen acid pocket, night time reflux and symptoms and whether an alginate antacid preparation (Gaviscon Advance®) is useful in suppression of acid pocket, night time refluxes and symptom (s). A benefit is that this study may inform doctors and advise participants of GERD side-effects of late night supper and how Gaviscon Advance may help.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Aged greater than or equal to 18 years and less than or equal to 70 years. 2. BMI \>27.5 (based on kg/m2) 4\. Not taking acid suppressant PPI and H2 receptor blockers 5. Not taking antacids or alginate preparations, except those administered as part of study procedure. Exclusion Criteria: 1. Those with gastrointestinal symptoms indicative of GERD, gastric carcinoma, previous or current peptic ulcer disease. 2. Those with a history of upper GI surgery prior to this. 3. Those with haematological disorders, bleeding tendency, recurrent nose bleeds or treatment with anti-coagulants). 4. Those who had any previous history of allergy or known intolerance to any of the study drugs or the following formulation constituents: Gaviscon® liquid: sodium alginate, sodium bicarbonate and calcium carbonate 5. Those with physical, neurological or psychiatric conditions preventing repeated visits to hospital or compliance with study procedures.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Hospitial Universiti Sains Malaysia
Kubang Kerian, MalaysiaOpen Hospitial Universiti Sains Malaysia in Google Maps