galactomannan and Gastroesophageal-Reflux

Proton Pump Inhibitors (PPIs) and traditional antacids are the common standard set of therapy for the management of gastroesophageal reflux disease (GERD) symptoms. The aim of the current study was to evaluate efficacy and safety of a novel galactomannan-based liquid formulation in reducing typical GERD symptoms in patients not taking PPIs.. This was a single-center, randomized, double-blind, placebo-controlled study. Sixty patients met the eligibility criteria and were treated either with the investigational product (RefluG™) or placebo, one sachet three times per day for 14 consecutive days. Symptom intensity/frequency and quality of life were assessed over the course of the study by Reflux Disease Questionnaire (RDQ) and GERD-Health related Quality of life (HRQL) Questionnaire, respectively. The primary endpoint was to determine the number of subjects with at least 30% symptoms reduction from baseline to day 14 compared to placebo.. RefluG™ was statistically superior to placebo (p <0.001) as 100% of subjects experienced at least 30% symptoms reduction at the end of the study while none achieved a 30% reduction in the placebo group. For all domains both after 7 and 14 days of treatment, significant improvement in HRQL was seen in the active group in comparison to placebo. Tolerability and safety were good and comparable between groups.. The investigational product was safe and effective as mono-therapy in providing early resolution of troublesome GERD symptoms as well as for improving quality of life.

Topics: Adult; Double-Blind Method; Female; Galactose; Gastroesophageal Reflux; Humans; Male; Mannans; Middle Aged; Treatment Outcome

Milk formulas enriched with water-soluble fibers are a first-line measure for infants with gastroesophageal reflux. However, it has been reported that these compounds could affect gastric emptying. The aim of this study was to evaluate the effects of these thickeners on gastric emptying time in infants with frequent regurgitation or vomiting.. Forty-seven infants, aged 1 to 12 months, with uncomplicated gastroesophageal reflux underwent two ultrasound evaluations of gastric emptying time after receiving either a standard formula or a formula enriched with 0.4 g galactomannan per 100 ml diluted milk. Gastric emptying time was calculated by measuring the antrum area at baseline and at defined intervals over the next 3 hours.. The gastric emptying time (mean +/- SD) for the standard and the thickened formula was 136 +/- 33 and 133 +/- 34 minutes, respectively. There was no significant difference in the gastric emptying patterns of the two formulas. Gastric emptying time was longer after the standard formula in 15 of the 47 subjects, shorter in 15 of the 47, and the same in 17 of the 47.. The ingestion of a water-soluble fiber-enriched formula does not have any significant influence on the gastric emptying time of infants with frequent regurgitation or vomiting.

Topics: Dietary Fiber; Female; Galactose; Gastric Emptying; Gastroesophageal Reflux; Humans; Infant Food; Infant, Newborn; Male; Mannans; Pyloric Antrum; Time Factors; Ultrasonography

Topics: Antidiarrheals; Aspergillosis; False Positive Reactions; Female; Galactans; Galactose; Gastroesophageal Reflux; Humans; Infant; Infant Food; Infant Formula; Leukemia, Myeloid, Acute; Mannans; Plant Gums