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
Alginate-antacid group
+ Non antacid alginate group
Trastornos de deglución+9
+ Peso Corporal
+ Enfermedades del Sistema Digestivo
Estudio de Tratamiento
Resumen
Fecha de inicio: 1 de julio de 2016
Fecha en la que se inscribió al primer participante.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.
Protocolo
Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.Se reclutarán 24 pacientes
Número total de participantes que el ensayo clínico espera reclutar.Estudio de Tratamiento
Elegibilidad
Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.Cualquier sexo
Sexo biológico de los participantes elegibles para inscribirse.De 18 a 70 años
Rango de edades de los participantes que pueden unirse al estudio.Voluntarios sanos permitidos
Indica si personas sanas, sin la condición que se estudia, pueden participar.Condiciones
Patología
Criterios
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.
Plan de Estudio
Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.2 grupos de intervención están designados en este estudio
0% de probabilidad de ser asignado al grupo placebo
Grupos de Tratamiento
Grupo I
ExperimentalGrupo II
ExperimentalObjetivos del Estudio
Objetivos Primarios
Objetivos Secundarios
Centros del Estudio
Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.Este estudio tiene una ubicación
Hospitial Universiti Sains Malaysia
Kubang Kerian, MalaysiaAbrir Hospitial Universiti Sains Malaysia en Google Maps