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A 12 Week Maintenance Therapy with a New Prepared Viscous Budesonide (PVB) in Pediatric Eosinophilic Esophagitis
AGA Abstracts
16/16, IFX: n=6/7), but few patients developed severe CDI (VDZ: n=1/16, IFX n=1/7) or required hospitalization for CDI (VDZ n=3/16, IFX n=3/7). There was no difference in CDI recurrence rates between VDZ and IFX treated patients (44% vs. 38%, p=1.00), and no patients required colectomy for CDI. The use of triple immunosuppression was the only predictor for the development of any enteric infections (HR 3.36, 95% CI 1.48 - 7.62), or specifically CDI (HR 3.11, 95% CI 1.35 - 7.19). Conclusion: In this cohort study, rates of enteric infections and CDI were similar between patients treated with vedolizumab and infliximab in clinical practice, and outcomes were favorable with only a minority of patients requiring hospitalization. Use of triple immunosuppression, but not use of vedolizumab specifically, was the primary risk factor for CDI and other enteric infections.
associated with increased hospitalization risk in addition to increased total, pulmonary and gastrointestinal admission nights, as shown in table 2. For those patients not on PPI prior to their VFSS, 26.2% (n=34) were put on PPI after the VFSS and this subgroup also had significantly increased total and gastrointestinal admissions after starting PPI compared to the same period of time when the patient was not taking PPI. For this subgroup, patients had 0.61 ± 0.12 total admissions before starting PPI and 1.67 ± 0.29 after starting PPI (p= 0.001). They also had 0.12 ± 0.07 gastrointestinal admissions before starting PPI and 0.46 ± 0.13 after starting PPI (p=0.019). Conclusions: Children with aspiration who are treated with PPI have more than double the rate of total, pulmonary, and gastrointestinal hospitalizations and this risk is further increased in children without neurologic comorbidities, who have more than quadruple the number of total admission nights. These results support growing concern about the risks of PPI use and suggest the need to reevaluate the use of pharmacologic acid suppression in children with aspiration.
458 A COORDINATED CARE APPROACH TO COMPLEX PEDIATRIC AERODIGESTIVE PATIENTS REDUCES ANESTHESIA EXPOSURE AND HEALTHCARE COSTS Eric Chiou, Timothy Vece, Julie E. Nicholson, Kathryne Basta, Priya Raj, Shailendra Das, Mehta K. Deepak, Mcconnell A. Ruth, Ongkasuwan Julina Introduction: Children with complex respiratory and co-existing swallowing or gastrointestinal problems who are followed by multiple subspecialists often encounter barriers to communication and coordination of care. The multidisciplinary Aerodigestive Program at Texas Children's Hospital aims to improve patient care utilizing a coordinated care approach. The goal of this study was to evaluate the impact of such an approach on anesthesia exposure and its associated risks, incidence of peri-operative complications, and overall health care costs in children with aerodigestive disorders who require endoscopic evaluation. Methods: Charts for all patients undergoing diagnostic direct laryngoscopy and rigid tracheoscopy (DL), flexible bronchoscopy and bronchoalveolar lavage (BAL), and esophagogastroduodenoscopy (EGD) as part of the Aerodigestive Program between December 2011 and December 2014 were reviewed. For comparison, patients who underwent these procedures individually during the same time period were also analyzed and categorized as controls. Parameters evaluated were American Society of Anesthesiologists (ASA) physical status classification, anesthesia time, post anesthesia care unit (PACU) time, perioperative complications, unexpected post-operative admission, and associated financial charges. Results: A total of 83 patients underwent combined DL, flexible bronchoscopy with BAL and EGD as part of the Aerodigestive Program. The median age of patients at the time of the procedure was 2.3 years (range 0.18 - 15.78 years). Comparisons between patients seen in the Aerodigestive Program versus patients who underwent endoscopic procedures separately are shown in the Table. Compared to patients who underwent procedures separately, a coordinated care approach was associated with estimated reductions in anesthesia time by 42 minutes, PACU recovery time by 100 minutes, and financial charges by $12,910 per patient. There was no significant difference in rate of complications or unexpected admissions between patients who underwent combined procedures versus separate procedures. Conclusions: Children with aerodigestive disorders who underwent a coordinated endoscopic evaluation experienced a reduction of exposure to general anesthesia and its associated risks, and was more costeffective, compared to non-coordinated care. Mean anesthesia time, PACU time and financial charges for combined Aerodigestive cases versus individual procedures performed separately
460 A 12 WEEK MAINTENANCE THERAPY WITH A NEW PREPARED VISCOUS BUDESONIDE (PVB) IN PEDIATRIC EOSINOPHILIC ESOPHAGITIS Salvatore Oliva, Danilo Rossetti, Saverio Mallardo, Paolo Rossi, Sara Isoldi, Antonio Tiberti, Sandra Lucarelli, Salvatore Cucchiara Background and aims A new pre-prepared oral viscous budesonide (PVB) has been effective in inducing clinical and histological remission in pediatric Eosinophilic Esophagitis (EoE). This study aims to evaluate the efficacy of a 12-week maintenance therapy with PVB on clinical, endoscopic and histological remission. Methods We prospectively enrolled pediatric patients with active EoE (diagnosed according to the ESPGHAN criteria, J Pediatr Gastroenterol Nutr 2014;58:107-18). After 12 weeks of induction therapy with PVB (< 150 cm: 2 mg bid; >150cm: 4 mg bid), patients achieving a complete histological remission (a peak eosinophil count of <6/HPF in all esophageal levels) underwent a maintenance remission phase with half dose of PVB (1mg or 2mg) for other 12 weeks. Endoscopy was performed at 0,12,24 and 36 weeks. Clinical symptom score (CSS) (Gupta SK, Clin Gastroenterol Hepatol 2015;13:66-76), endoscopy (EoE Endoscopic Reference Score, EREFS, modified) (Gut 2013;62:489-95) and histology (count of eosinophils/hpf at all esophageal levels) were evaluated. Serum cortisol was evaluated at baseline, 12, 24 and 36 weeks. Results We enrolled 20 children (15 male, 5 female; median age 10 years, range 4-10). After 12 weeks of induction therapy (week 12), 18 patients (90%) were in remission, exhibiting a striking reduction in clinical, endoscopic and histologic scores (p<0,01). At the end of maintenance therapy (week 24), remission was still observed in 17 patients (85%), while only in 9 (45%) at week 36 (12 weeks after the end of treatment). No significant difference in cortisol levels was observed during the study period as compared to baseline pre-trial values Conclusions In the great majority of patients with EoE, initially responding to PVB, a dose reduction of the latter was effective in maintaining remission at week 24. However, this effect did not continue at a 12 week follow up after the end of the treatment. According to these results, in EoE pediatric patients PVB might be proposed for a long-term therapeutic strategy to maintain remission of the disease.
459 PROTON PUMP INHIBITORS WORSEN HOSPITALIZATION RISK IN PEDIATRIC PATIENTS WITH ASPIRATION Daniel Duncan, Kara Larson, Lisa Hester, Maireade E. McSweeney, Rachel Rosen Background: There is growing concern in the medical community about the risks of proton pump inhibitors (PPIs). PPIs cause alterations in the microbiome as well as increased risk of both pulmonary and gastrointestinal infections in patients taking PPIs. Because of these concerns, there is a possible risk to prescribing these medications in children with oropharyngeal dysphagia and aspiration; the concern is that these medications may actually worsen respiratory symptoms and infection. The aim of this study was to determine if there is increased risk of hospitalization in pediatric patients with aspiration who are treated with PPIs compared to untreated patients. Methods: We retrospectively reviewed the records of children with evidence of aspiration and/or penetration on videofluoroscopic swallow studies (VFSS) at Boston Children's Hospital from January 2015 to December 2015 to determine patient characteristics, including PPI status, and the number, length and types of hospitalizations in the year following the diagnosis of aspiration. Hospitalizations were categorized into three groups: total, pulmonary and gastrointestinal hospitalizations. Data are presented as mean ± standard error. Results: We evaluated 206 subjects with a mean age of 8.65±0.47 months who were found to have aspiration or penetration on VFSS; 55.3% (n=114) had aspiration and 44.7% (n=92) had penetration on VFSS. 36.1% (n=74) of patients were on PPI before and 47.8% (n=98) were on PPI after their VFSS. PPI treated patients had significantly more total, pulmonary and gastrointestinal hospitalizations, as shown in table 1. When we excluded all patients with neurologic compromise (n=59), PPI use was still
AGA Abstracts
461 UNIQUE GROWTH CHARACTERISTICS OF E. COLI VIA THE NTRB/NTRC TWO-COMPONENT SYSTEM IN VITRO VS. IN VIVO A SIGNAL TRANSDUCTION PATHWAY ASSOCIATED WITH DYSBIOSIS IN IBD Chiraag Kulkarni, Josephine Ni, Eric Barash, Manuela Roggiani, Mark Goulian, Gary D. Wu Background: Crohn's disease is associated with bacterial dysbiosis consisting of reduced bacterial diversity and outgrowth of Proteobacteria, notably Enterobacteriaceae. However, a definitive mechanism for the development of dysbiosis is not known. An analysis of the gut microbiome in pediatric Crohn's disease revealed a genomic signature for nitrogen metabolism associated with dysbiosis. Specifically, a bacterial two-component system responsible for sensing and responding to environmental nitrogen sources, ntrC, was associated with dysbiosis, an increase in fecal amino acids, and the abundance of E. coli. Herein, we examined the effect of ntrC on growth characteristics of E. coli under different environmental conditions in vitro as well as its effects on intestinal colonization in vivo. Methods: ∆ntrC and wild-type MP1, a murine commensal strain of E. coli, were cultured under aerobic and anaerobic conditions using lysogeny broth (LB) and M9 minimal media. C57/BL6 mice were
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16/16, IFX: n=6/7), but few patients developed severe CDI (VDZ: n=1/16, IFX n=1/7) or required hospitalization for CDI (VDZ n=3/16, IFX n=3/7). There was no difference in CDI recurrence rates between VDZ and IFX treated patients (44% vs. 38%, p=1.00), and no patients required colectomy for CDI. The use of triple immunosuppression was the only predictor for the development of any enteric infections (HR 3.36, 95% CI 1.48 - 7.62), or specifically CDI (HR 3.11, 95% CI 1.35 - 7.19). Conclusion: In this cohort study, rates of enteric infections and CDI were similar between patients treated with vedolizumab and infliximab in clinical practice, and outcomes were favorable with only a minority of patients requiring hospitalization. Use of triple immunosuppression, but not use of vedolizumab specifically, was the primary risk factor for CDI and other enteric infections.
associated with increased hospitalization risk in addition to increased total, pulmonary and gastrointestinal admission nights, as shown in table 2. For those patients not on PPI prior to their VFSS, 26.2% (n=34) were put on PPI after the VFSS and this subgroup also had significantly increased total and gastrointestinal admissions after starting PPI compared to the same period of time when the patient was not taking PPI. For this subgroup, patients had 0.61 ± 0.12 total admissions before starting PPI and 1.67 ± 0.29 after starting PPI (p= 0.001). They also had 0.12 ± 0.07 gastrointestinal admissions before starting PPI and 0.46 ± 0.13 after starting PPI (p=0.019). Conclusions: Children with aspiration who are treated with PPI have more than double the rate of total, pulmonary, and gastrointestinal hospitalizations and this risk is further increased in children without neurologic comorbidities, who have more than quadruple the number of total admission nights. These results support growing concern about the risks of PPI use and suggest the need to reevaluate the use of pharmacologic acid suppression in children with aspiration.
458 A COORDINATED CARE APPROACH TO COMPLEX PEDIATRIC AERODIGESTIVE PATIENTS REDUCES ANESTHESIA EXPOSURE AND HEALTHCARE COSTS Eric Chiou, Timothy Vece, Julie E. Nicholson, Kathryne Basta, Priya Raj, Shailendra Das, Mehta K. Deepak, Mcconnell A. Ruth, Ongkasuwan Julina Introduction: Children with complex respiratory and co-existing swallowing or gastrointestinal problems who are followed by multiple subspecialists often encounter barriers to communication and coordination of care. The multidisciplinary Aerodigestive Program at Texas Children's Hospital aims to improve patient care utilizing a coordinated care approach. The goal of this study was to evaluate the impact of such an approach on anesthesia exposure and its associated risks, incidence of peri-operative complications, and overall health care costs in children with aerodigestive disorders who require endoscopic evaluation. Methods: Charts for all patients undergoing diagnostic direct laryngoscopy and rigid tracheoscopy (DL), flexible bronchoscopy and bronchoalveolar lavage (BAL), and esophagogastroduodenoscopy (EGD) as part of the Aerodigestive Program between December 2011 and December 2014 were reviewed. For comparison, patients who underwent these procedures individually during the same time period were also analyzed and categorized as controls. Parameters evaluated were American Society of Anesthesiologists (ASA) physical status classification, anesthesia time, post anesthesia care unit (PACU) time, perioperative complications, unexpected post-operative admission, and associated financial charges. Results: A total of 83 patients underwent combined DL, flexible bronchoscopy with BAL and EGD as part of the Aerodigestive Program. The median age of patients at the time of the procedure was 2.3 years (range 0.18 - 15.78 years). Comparisons between patients seen in the Aerodigestive Program versus patients who underwent endoscopic procedures separately are shown in the Table. Compared to patients who underwent procedures separately, a coordinated care approach was associated with estimated reductions in anesthesia time by 42 minutes, PACU recovery time by 100 minutes, and financial charges by $12,910 per patient. There was no significant difference in rate of complications or unexpected admissions between patients who underwent combined procedures versus separate procedures. Conclusions: Children with aerodigestive disorders who underwent a coordinated endoscopic evaluation experienced a reduction of exposure to general anesthesia and its associated risks, and was more costeffective, compared to non-coordinated care. Mean anesthesia time, PACU time and financial charges for combined Aerodigestive cases versus individual procedures performed separately
460 A 12 WEEK MAINTENANCE THERAPY WITH A NEW PREPARED VISCOUS BUDESONIDE (PVB) IN PEDIATRIC EOSINOPHILIC ESOPHAGITIS Salvatore Oliva, Danilo Rossetti, Saverio Mallardo, Paolo Rossi, Sara Isoldi, Antonio Tiberti, Sandra Lucarelli, Salvatore Cucchiara Background and aims A new pre-prepared oral viscous budesonide (PVB) has been effective in inducing clinical and histological remission in pediatric Eosinophilic Esophagitis (EoE). This study aims to evaluate the efficacy of a 12-week maintenance therapy with PVB on clinical, endoscopic and histological remission. Methods We prospectively enrolled pediatric patients with active EoE (diagnosed according to the ESPGHAN criteria, J Pediatr Gastroenterol Nutr 2014;58:107-18). After 12 weeks of induction therapy with PVB (< 150 cm: 2 mg bid; >150cm: 4 mg bid), patients achieving a complete histological remission (a peak eosinophil count of <6/HPF in all esophageal levels) underwent a maintenance remission phase with half dose of PVB (1mg or 2mg) for other 12 weeks. Endoscopy was performed at 0,12,24 and 36 weeks. Clinical symptom score (CSS) (Gupta SK, Clin Gastroenterol Hepatol 2015;13:66-76), endoscopy (EoE Endoscopic Reference Score, EREFS, modified) (Gut 2013;62:489-95) and histology (count of eosinophils/hpf at all esophageal levels) were evaluated. Serum cortisol was evaluated at baseline, 12, 24 and 36 weeks. Results We enrolled 20 children (15 male, 5 female; median age 10 years, range 4-10). After 12 weeks of induction therapy (week 12), 18 patients (90%) were in remission, exhibiting a striking reduction in clinical, endoscopic and histologic scores (p<0,01). At the end of maintenance therapy (week 24), remission was still observed in 17 patients (85%), while only in 9 (45%) at week 36 (12 weeks after the end of treatment). No significant difference in cortisol levels was observed during the study period as compared to baseline pre-trial values Conclusions In the great majority of patients with EoE, initially responding to PVB, a dose reduction of the latter was effective in maintaining remission at week 24. However, this effect did not continue at a 12 week follow up after the end of the treatment. According to these results, in EoE pediatric patients PVB might be proposed for a long-term therapeutic strategy to maintain remission of the disease.
459 PROTON PUMP INHIBITORS WORSEN HOSPITALIZATION RISK IN PEDIATRIC PATIENTS WITH ASPIRATION Daniel Duncan, Kara Larson, Lisa Hester, Maireade E. McSweeney, Rachel Rosen Background: There is growing concern in the medical community about the risks of proton pump inhibitors (PPIs). PPIs cause alterations in the microbiome as well as increased risk of both pulmonary and gastrointestinal infections in patients taking PPIs. Because of these concerns, there is a possible risk to prescribing these medications in children with oropharyngeal dysphagia and aspiration; the concern is that these medications may actually worsen respiratory symptoms and infection. The aim of this study was to determine if there is increased risk of hospitalization in pediatric patients with aspiration who are treated with PPIs compared to untreated patients. Methods: We retrospectively reviewed the records of children with evidence of aspiration and/or penetration on videofluoroscopic swallow studies (VFSS) at Boston Children's Hospital from January 2015 to December 2015 to determine patient characteristics, including PPI status, and the number, length and types of hospitalizations in the year following the diagnosis of aspiration. Hospitalizations were categorized into three groups: total, pulmonary and gastrointestinal hospitalizations. Data are presented as mean ± standard error. Results: We evaluated 206 subjects with a mean age of 8.65±0.47 months who were found to have aspiration or penetration on VFSS; 55.3% (n=114) had aspiration and 44.7% (n=92) had penetration on VFSS. 36.1% (n=74) of patients were on PPI before and 47.8% (n=98) were on PPI after their VFSS. PPI treated patients had significantly more total, pulmonary and gastrointestinal hospitalizations, as shown in table 1. When we excluded all patients with neurologic compromise (n=59), PPI use was still
AGA Abstracts
461 UNIQUE GROWTH CHARACTERISTICS OF E. COLI VIA THE NTRB/NTRC TWO-COMPONENT SYSTEM IN VITRO VS. IN VIVO A SIGNAL TRANSDUCTION PATHWAY ASSOCIATED WITH DYSBIOSIS IN IBD Chiraag Kulkarni, Josephine Ni, Eric Barash, Manuela Roggiani, Mark Goulian, Gary D. Wu Background: Crohn's disease is associated with bacterial dysbiosis consisting of reduced bacterial diversity and outgrowth of Proteobacteria, notably Enterobacteriaceae. However, a definitive mechanism for the development of dysbiosis is not known. An analysis of the gut microbiome in pediatric Crohn's disease revealed a genomic signature for nitrogen metabolism associated with dysbiosis. Specifically, a bacterial two-component system responsible for sensing and responding to environmental nitrogen sources, ntrC, was associated with dysbiosis, an increase in fecal amino acids, and the abundance of E. coli. Herein, we examined the effect of ntrC on growth characteristics of E. coli under different environmental conditions in vitro as well as its effects on intestinal colonization in vivo. Methods: ∆ntrC and wild-type MP1, a murine commensal strain of E. coli, were cultured under aerobic and anaerobic conditions using lysogeny broth (LB) and M9 minimal media. C57/BL6 mice were
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