Efficacy of Gaviscon-Advance® in Suppressing Post-supper Acid-pocket and Night-time Acid-reflux in Obese Participants

Phase 2

Completed

• Conditions: Gastroesophageal Reflux Disease; Acid Reflux; Obesity
• Interventions: Drug: Alginate-antacid group; Drug: Non antacid alginate group

• Registration Number: NCT03516188
• Lead Sponsor: Universiti Sains Malaysia

Brief 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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Study First Submitted: 2017-10-18
• Status Verified: 2018-05
• Study First Submitted QC: 2018-05-03
• Last Update Submitted: 2018-05-03
• Study First Posted: 2018-05-04
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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)

3. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alginate-antacid group	Alginate-antacid group	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	Non antacid alginate group	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.

Primary Outcome Measures

Name	Time	Method
Duration of acid-pocket	48 hours	Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes.

Secondary Outcome Measures

Name	Time	Method
Symptom response	48 hours	Symptom response will be assessed using visual analogue scale (0 - 10).
Acidity of acid-pocket	48 hours	Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH.
Frequency of night-time reflux	48 hours	Frequency of night-time reflux will be assessed using pH-impedance studies.

Trial Locations

Locations (1)

Hospitial Universiti Sains Malaysia; 🇲🇾 Kubang Kerian, Kelantan, Malaysia