Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants
Condition: Gastroesophageal Reflux Disease; Acid Reflux; Obesity
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      A randomized, open-label study with antacid-control will be performed over 48 hours period by
      continuous pH impedance and bravo capsule monitoring. Asymptomatic obese patients will be
      separated into either groups according to alginate antacid group [Gaviscon Advance (GA)®,
      Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be
      studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants
      according to their group will take either alginate antcid [Gaviscon Advance (GA)®, Reckitt
      Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of
      antacid after taking late night standardised meals.
    

Detailed description: 
      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.
    

Intervention name(s): Alginate-antacid group; Non antacid alginate group
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom); Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.
Other intervention name(s): Gaviscon-Advance®; Magnesium tri-silicate
Intervention MeSH terms: Antacids
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Asymptomatic obese patients will be randomised into either groups according to alginate antacid group [Gaviscon Advance (GA), Reckitt Benckiser, UK] and non antacid alginate group [simple antacid]. Both groups will be studied for 48 hours using the ambulatory wireless capsule and pH impedance. Participants according to their group will take either alginate antcid [Gaviscon Advance (GA), Reckitt Benckiser, UK] or non alginate antacid [simple antacid] which has equivalent strength of antacid after taking late night standardised meals.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gastroesophageal Reflux Disease; Acid pocket; Acid Reflux; Alginate antacid; Obesity