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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)Ā®, 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)Ā®, 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 AdvanceĀ®) 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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alginate-antacid group | Experimental | Participants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus alginate-antacid. |
|
| Non antacid alginate group | Experimental | Participants will take normal meals with late night supper (i.e.two chicken burgers and one cup or 250 ml of teh-tarik) plus antacid alone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Alginate-antacid group | Drug | Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-AdvanceĀ®, Reckitt-Benckiser, United Kingdom) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Duration of acid-pocket | Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes. | 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom response | Symptom response will be assessed using visual analogue scale (0 - 10). | 48 hours |
| Acidity of acid-pocket | Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH. |
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Inclusion Criteria:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Yeong Yeh Lee, MD, PhD | Universiti Sains Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospitial Universiti Sains Malaysia | Kubang Kerian | Kelantan | 16150 | Malaysia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32343001 | Derived | Deraman MA, Abdul Hafidz MI, Lawenko RM, Ma ZF, Wong MS, Coyle C, Lee YY. Randomised clinical trial: the effectiveness of Gaviscon Advance vs non-alginate antacid in suppression of acid pocket and post-prandial reflux in obese individuals after late-night supper. Aliment Pharmacol Ther. 2020 Jun;51(11):1014-1021. doi: 10.1111/apt.15746. Epub 2020 Apr 28. |
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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.
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No masking
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| Non antacid alginate group | Drug | Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-AdvanceĀ® except it is alginate-free. |
|
|
| 48 hours |
| Frequency of night-time reflux | Frequency of night-time reflux will be assessed using pH-impedance studies. | 48 hours |
| ID | Term |
|---|---|
| D005764 | Gastroesophageal Reflux |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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