Alkaline gastritis due to duodenogastric reflux Alkaline gastritis
Conditions
Interventions
Gastricel Group (Experimental): Orally, a dose of microcrystalline cellulose suspension, a 15 mL spoonful, three times a day, for three months.
Sucralfate Group (Control): Orally, one dose of sucralfa
Administration, Oral
Microcrystalline cellulose in suspension
Sponsors
Center for Pharmaceutical Research and Development, Havana, Cuba.
Pharmaceutical Laboratory Oral Liquids (Medilip), Bayamo, Cuba
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1- Patients with chronic alkaline gastritis due to duodenogastric reflux, diagnosed by clinical and endoscopic study and gastric biopsy. 2- Patients with bile reflux with intact or operated stomach, or patients with intact stomach but who have been surgically removed from the gallbladder. 3- Presence of one or more symptoms of the following: epigastralgia, pyrosis, vomiting (bilious or not). 4- Hematological and biochemical studies within the established ranges. 5-Written informed consent of the patient to participate in the investigation and to complete the established examinations.
Exclusion criteria
Exclusion criteria: 1- Pregnancy, breastfeeding or puerperium. 2- Helicobacter pylori positive demonstrated by the method of urease and/or biopsy. 3- Patients with known chronic evolutive liver diseases that could alter the production in quantity or quality of bile acids. 4- Malabsorption syndrome produced by any etiology that could influence the excretion of bile acids. 5- Presence of duodenogastric reflux of haematic appearance in the endoscopy prior to inclusion in the study. 6- Malignant disease. 7- History of allergy or hypersensitivity to any component of the formulation. 8- Severe psychiatric disorder or mental incapacity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Bilious vomiting (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 2. Pyrosis (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 3. Epigastralgia. (Present, Absent). Measurement time: at baseline and, at the end of months 1, 2 and 3. 4. Degree of Gastritis associated with bile reflux (It will be classified in Grade 0, I, II, III by an endoscopy. The endoscopic definition defined by the Sydney System will be applied). Measurement time: at baseline, at first month, and at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Ingles 1- Degree of gastritis associated with bile reflux (It will be classified in Grade 0, I, II, III. The morphological descriptions of the Sydney System for measurable variables: inflammation, activity, atrophy and intestinal metaplasia, will be used). Measurement time: at baseline and, 3 months. 2- Presence of adverse events-AE (distribution frequency for the appearance of AE (Yes, No), type of event (name of the AE), duration (time from appearance until stop the event), severity (severe, non-severe), intensity of AE (grades 1-5), relation of causality (remote, possible, probable, very probable), result of AE (recuperate, improvement, persist or sequels), attitude concerning the studied treatment (without changes, dose modification, temporal or definitive treatment discontinuation)). Measuring time: At each administration until end of treatment. | — |
Countries
Cuba
Contacts
Public ContactIdrian Garcia Garcia
Center for Pharmaceutical Research and Development (CIDEM)
Outcome results
None listed