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Background Gastroesophageal reflux frequently occurs in infants from birth to 2 years and is characterised by reflux and regurgitation often occurring during or immediately after feeds. These reflux events can range in both frequency and severity, and as the reflux events increase, they become increasingly distressing for both the infant and the parent. The study aimed to characterise the properties of a new infant liquid alginate product, determining the optimum gastric pH and dose volume for maximum reflux suppressant activity. Methods An in vitro infant stomach model was designed and developed that allowed products to be assessed for their reflux suppression activity. The validation of the model was completed by three independent operators comparing a milk control with infant Gaviscon to evaluate the models' robustness, reproducibility, and ease of use. The model was used to establish reflux suppression activity of a new liquid alginate infant formulation in comparison with a milk control. Suppression activity was assessed at varying doses and pH within a physiological range. Results The validation study demonstrated no significant difference in refluxate volumes for the milk control within each reflux event when comparing across the three individual operators. Similarly, no statistical differences were seen during the infant Gaviscon experiments, confirming the robustness and reproducibility of the model. Significant reflux suppression was seen across the pH range (except at pH 5.75); the pH most advantageous for reflux suppression was pH 5.25. The optimum dose volume for consistently suppressing reflux was shown to be 5 ml. An infant stomach model was designed for evaluating reflux suppression activity of a formulation of liquid alginate. The optimum gastric pH and dose volume for demonstrating significant reflux suppression and the thickening of formula milk by the infant liquid alginate formulation were established. Conclusion This study confirms the mode of action of the alginate formula, demonstrating a superior reduction in the retrograde movement of in vitro gastric contents and volume of regurgitation. The study also demonstrates that optimal performance occurs in conditions that are in line physiologically with the target patient. Both actions compliment and support the efficacy of the alginate formulation as a reflux therapy agent.
Background Gastroesophageal reflux frequently occurs in infants from birth to 2 years and is characterised by reflux and regurgitation often occurring during or immediately after feeds. These reflux events can range in both frequency and severity, and as the reflux events increase, they become increasingly distressing for both the infant and the parent. The study aimed to characterise the properties of a new infant liquid alginate product, determining the optimum gastric pH and dose volume for maximum reflux suppressant activity. Methods An in vitro infant stomach model was designed and developed that allowed products to be assessed for their reflux suppression activity. The validation of the model was completed by three independent operators comparing a milk control with infant Gaviscon to evaluate the models' robustness, reproducibility, and ease of use. The model was used to establish reflux suppression activity of a new liquid alginate infant formulation in comparison with a milk control. Suppression activity was assessed at varying doses and pH within a physiological range. Results The validation study demonstrated no significant difference in refluxate volumes for the milk control within each reflux event when comparing across the three individual operators. Similarly, no statistical differences were seen during the infant Gaviscon experiments, confirming the robustness and reproducibility of the model. Significant reflux suppression was seen across the pH range (except at pH 5.75); the pH most advantageous for reflux suppression was pH 5.25. The optimum dose volume for consistently suppressing reflux was shown to be 5 ml. An infant stomach model was designed for evaluating reflux suppression activity of a formulation of liquid alginate. The optimum gastric pH and dose volume for demonstrating significant reflux suppression and the thickening of formula milk by the infant liquid alginate formulation were established. Conclusion This study confirms the mode of action of the alginate formula, demonstrating a superior reduction in the retrograde movement of in vitro gastric contents and volume of regurgitation. The study also demonstrates that optimal performance occurs in conditions that are in line physiologically with the target patient. Both actions compliment and support the efficacy of the alginate formulation as a reflux therapy agent.
Abstract:Background & Aims: The role of high resolution esophageal impedance manometry (HRIM) for establishing risk for dysphagia after anti-reflux surgery is unclear. We conducted a prospective study of children with primary GER disease, for whom symptoms of dysphagia to solids were determined pre-and post-operatively and we examined for features that may predict post-operative dysphagia. Methods: Thirteen children (aged 6.8 -15.5 years) undergoing work up prior to 360o Nissen fundoplication were included. A dysphagia score assessed symptoms. A HRIM procedure recorded 5ml liquid, 5ml viscous and 2cm solid boluses. We assessed esophageal motility, esophago-gastric junction (EGJ) morphology, EGJ contractility and pressure-flow variables indicative of bolus distension pressures and bolus clearance pressures. A composite pressure-flow-index score (PFI) was also derived. Results: Pre-operative PFI was positively correlated with post-operative dysphagia score (PFI viscous bolus r = 0.771, p<0.005 Abbreviations: HRIM, high resolution impedance manometry; GER, gastroesophageal reflux; EGJ, esophago-gastric junction; LES, lower esophageal sphincter; CD, crural diaphragm; TZ, transition zone; CDP, contractile deceleration point; pH-MII, pH with multichannel intraluminal impedance; PPI, proton pump inhibitor; EPT, esophageal pressure topography; IRP4s, 4s integrated relaxation pressure; CFV, contractile front velocity; DCI, distal contractile integral; DL, distal latency; EGJ-CI, EGJ contractile index; DPA, distension pressure during bolus accommodation; DPCT, distension pressure during compartmentalized transport; DPE, distension pressure during esophageal emptying; PFI, pressure-flow-index; IR, impedance ratio; SDL, swallow to distension latency; DCL, distension to contraction latency; RP, ramp pressure; IEM, ineffective esophageal motility; EoE, eosinophilic esophagitis. Acknowledgements:We thank Mrs G Seiboth, Mrs K Lowe and Ms S Kritas for assistance with performance of HRIM studies and Dr Junko Fujino for assistance with reviewing endoscopy images. • The ability to accurately predict post-operative dysphagia risk is of interest to gastroenterologists. 'Pressure-flow' anomalies may be predictors of dysphagia symptoms following anti-reflux surgery.• Past studies were performed using 'low-resolution' perfusion lower esophageal sphincter sleeve-manometry.2. What are the significant and/or new findings of this study?• Dysphagia symptoms were common in our pediatric GER disease patients who were receiving diagnostic work up for anti-reflux surgery.• Of all parameters evaluated, bolus 'clearing pressures' were most reliably associated with dysphagia symptoms. Results: Pre-operative pressure-flow index was positively correlated with post-operative dysphagia score (viscous bolus r = 0.771, p<0.005). Of three variables that comprise the pressure-flow index, the ramp pressure measured during bolus clearance was the main driver of the effect seen (viscous bolus r = 0.819, p<0.005). Conclusions:In order to mitigate symptoms i...
Cow’s milk allergy (CMA) and gastro-esophageal reflux disease (GERD) may manifest with similar symptoms in infants making the diagnosis challenging. While immediate reaction to cow’s milk protein indicate CMA, regurgitation, vomiting, crying, fussiness, poor appetite, sleep disturbances have been reported in both CMA and GERD and in other conditions such as functional gastrointestinal disorders, eosinophilic esophagitis, anatomic abnormalities, metabolic and neurological diseases. Gastrointestinal manifestations of CMA are often non-IgE mediated and clinical response to cow’s milk free diet is not a proof of immune system involvement. Neither for non-IgE CMA nor for GERD there is a specific symptom or diagnostic test. Oral food challenge, esophageal pH impedance and endoscopy are recommended investigations for a correct clinical classification but they are not always feasible in all infants. As a consequence of the diagnostic difficulty, both over- and under- diagnosis of CMA or GERD may occur. Quite frequently acid inhibitors are empirically started. The aim of this review is to critically update the current knowledge of both conditions during infancy. A practical stepwise approach is proposed to help health care providers to manage infants presenting with persistent regurgitation, vomiting, crying or distress and to solve the clinical dilemma between GERD or CMA.
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