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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03516188
• Other study ID #: 15020071
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: July 2016
• Est. completion date: June 2017

Study information

• Verified date: May 2018
• Source: University of Science Malaysia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acid Reflux
• Gastroesophageal Reflux
• Gastroesophageal Reflux Disease
• Heartburn
• Obesity

Intervention

Drug:
• Alginate-antacid group
Participants will be given 10 mL of alginate-antacid preparation (Gaviscon-Advance®, Reckitt-Benckiser, United Kingdom)
• Non antacid alginate group
Participants will be given 4 mL of magnesium tri-silicate which has equivalent strength and component with Gaviscon-Advance® except it is alginate-free.

Locations

Country	Name	City	State
Malaysia	Hospitial Universiti Sains Malaysia	Kubang Kerian	Kelantan

Sponsors (1)

Lead Sponsor	Collaborator
University of Science Malaysia

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of acid-pocket	Duration of acid-pocket will be assessed using Bravo capsules. The unit of measure is in minutes.	48 hours
Secondary	Symptom response	Symptom response will be assessed using visual analogue scale (0 - 10).	48 hours
Secondary	Acidity of acid-pocket	Acidity of acid-pocket will be assessed using Bravo capsules. The unit of measure is in pH.	48 hours
Secondary	Frequency of night-time reflux	Frequency of night-time reflux will be assessed using pH-impedance studies.	48 hours