Gastroesophageal Reflux Clinical Trial
Official title:
Prospective, Comparative, Randomized, Controlled Trial on the Efficacy of the Treatment of Gastroesophageal Reflux Infant With Magnesium Alginate
The results on the efficacy of the formulations based on alginic acid are controversial. Corvaglia et al demonstrated a significant reduction in reflux episodes in preterm infants by evaluation with pH-impedance analysis. This study concludes that the use of alginic acid reduces the acidity of the gastroesophageal reflux (GER) and has a non-systemic effect and a lesser presence of side effects compared to the use of H2-receptor antagonist(H2RA) and proton pump inhibitor (PPI).
Primary outcomes This prospective, randomized, controlled trial aims to determine, in a
population of infants within one year of life, suffering from gastroesophageal reflux (GER)
the effectiveness of magnesium alginate. The clinical improvement of the patient will be
evaluated based on the negativity of the symptom score (4.3.1), assessed using a validated
questionnaire on symptoms of GER (I-GERQ Annex A).
Secondary outcomes To compare the efficacy of Magnesium Alginate on GER in infants compared
with those of thickened feeding and reassurance, basing on questionnaire results.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05561179 -
Hyaluronic Acid in Patients With Gastroesophageal Reflux Disease
|
N/A | |
| Withdrawn |
NCT02213887 -
Study of the Effects of Pantoprazole on Levels of Prescribed Psychiatric Medications
|
Phase 4 | |
| Completed |
NCT01946971 -
Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
|
Phase 1/Phase 2 | |
| Recruiting |
NCT01825473 -
Study of Erythromycin in GER-Associated Apnea of the Newborn
|
N/A | |
| Completed |
NCT00614536 -
Study of Changes in Reflux Symptoms and Reflux Finding Score According to Rabeprazole Treatment Period
|
Phase 4 | |
| Completed |
NCT00373997 -
Esophageal and Laryngeal Tissue Changes in Patients Suspected of Having Laryngopharyngeal Reflux
|
Phase 4 | |
| Completed |
NCT00365300 -
Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)
|
Phase 3 | |
| Completed |
NCT00284908 -
Dose-Effect of S-Tenatoprazole-Na(STU-Na) 30 mg, 60 mg, 90 mg and 120 mg in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00215787 -
Investigation of the Association Between Nasal Polyposis and Extraesophageal Reflux Disease
|
N/A | |
| Completed |
NCT00226044 -
Rectal and Oral Omeprazole Treatment of Reflux Disease in Infants.
|
Phase 3 | |
| Completed |
NCT01167543 -
Relationship and Pathophysiology of Gastroesophageal Reflux and Dental/Periodontal Disease
|
N/A | |
| Completed |
NCT00291746 -
Validation of RDQ Questionnaire
|
Phase 4 | |
| Completed |
NCT00567021 -
German PMS Trial (AWB) to Evaluate Therapy in Reflux Disease and NSAR-Symptoms
|
N/A | |
| Completed |
NCT00141960 -
Famotidine in Subjects With Non-erosive Gastroesophageal Reflux Disease
|
Phase 2/Phase 3 | |
| Completed |
NCT00181805 -
Natural History of Gastroesophageal Reflux (GER) in Children and Adolescents
|
||
| Completed |
NCT01048840 -
Natural History of Gastroesophageal Reflux (GER) in Children < 12 Years of Age
|
||
| Terminated |
NCT01281553 -
A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
|
Phase 4 | |
| Completed |
NCT05486169 -
Gastroesophageal Reflux Disease After Laparoscopic Sleeve Gastrectomy
|
N/A | |
| Completed |
NCT04034017 -
Gastroesophageal Reflux Disease Among College Students
|
||
| Terminated |
NCT03226054 -
Determining Risk Factors for Successful PPI Weaning
|
N/A |