Need to compare the efficacy of alginate and antacids in preventing clinical reflux symptoms in scleroderma patients with refractory GERD who require an upper endoscopy, which necessitates stopping PPIs before the procedure. Alginate Scleroderma Gastroesophageal reflux disease Proton pump inhibition
Conditions
Interventions
After discontinuing acid suppression therapy, the patient will be randomly assigned to receive alginate (Gaviscon Advance Suspension, 10 ml QID) for about two weeks before the UGI endoscopy.,After dis
containing aluminum hydroxide, magnesium hydroxide, and simethicone) 30 ml QID for about two weeks before the UGI endoscopy.
Experimental Drug,Active Comparator Drug
Alginate,Antacid
Sponsors
Witsarut Manasirisuk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Scleroderma patients who are diagnosed according to the American College of Rheumatology criteria from 2013, and who have refractory gastroesophageal reflux disease defined by a lack of response to more than eight weeks of high-dose acid suppression therapy.
Exclusion criteria
Exclusion criteria: Allergy to antacids or alginate Pregnancy History of erosive esophagitis as defined by UGI endoscopy Contraindication for UGI endoscopy Active malignancy Uncontrolled medical conditions, such as: Severe heart failure (New York Heart Association [NYHA] functional class III or IV) Severe COPD (COPD GOLD stages C or D) Advanced chronic kidney disease (CKD stages G4 or G5) Active infection
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical of GERD by FSSG and GERDQ 2 weeks after discontinue acid suppression therapy Questionaire about reflux symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety profiles 2 weeks after discontinue acid suppression therapy Symptoms | — |
Countries
Thailand
Contacts
Public ContactWitsarut Manasirisuk
Khon Kaen University, Thailand
Outcome results
None listed