Obesity Clinical Trial
Official title:
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
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.
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.
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