HCPLive staff

2025 North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN)

 Annual Meeting, held November 5–8 at the Sheraton Grand Chicago in Chicago, Illinois, clinicians, researchers, and allied health professionals gathered to share the latest data, clinical updates, and expert perspectives in pediatric gastroenterology, hepatology, and nutrition. 

provided on-site reporting throughout the meeting, highlighting key findings across oral abstracts, posters, single- topic symposium sessions, and expert-led video interviews. 

 research, new pharmacologic therapies for irritable bowel syndrome with constipation (IBS-C), and long-term outcomes for patients with progressive cholestatic liver diseases. HCPLive will continue to provide coverage and updates from the meeting in the coming days, even as the conference concludes today.

Below, we recap our coverage of NASPGHAN 2025. 

Silvana Bonilla, MD, Explores Geographic Patterns of H. pylori in Pediatric Digestive Disease

New multicenter data presented by Silvana Bonilla, MD, attending physician, Pediatrics, Division of Gastroenterology, Hepatology and Nutrition, Boston Children’s Hospital, examined the prevalence of 

 infection (HPI) in children with eosinophilic esophagitis (EoE), celiac disease (CeD), or inflammatory bowel disease (IBD) across the Americas. Among 365 pediatric patients, overall HPI prevalence was 9.3%, with significant geographic variation—51.6% of positive cases were from Colombia, compared with 29% in the United States and 6.5% in Chile. HPI was more common in children with EoE and less frequent in those with CeD, highlighting the complex immunologic role of H. pylori in pediatric digestive diseases.

Click here to watch our discussion with Silvana Bonilla, MD.

H. pylori Geographical Prevalence and NASPGHAN/ESPGHAN Guidelines, With Silvana Bonilla, MD

In a video interview, Bonilla discussed how these findings align with the 2023 joint NASPGHAN/ESPGHAN guidelines, which conditionally recommend against routine H. pylori biopsies in children evaluated for IBD, CeD, or EoE. She emphasized that biopsies should be guided by clinical suspicion rather than performed routinely, and noted ongoing plans to follow patients longitudinally to assess potential protective effects of H. pylori and the influence of environmental shifts on immune-mediated digestive diseases.

Newly-Approved Linaclotide's Long-Term Safety Data

Long-term safety data for linaclotide (Linzess; Ironwood Pharmaceuticals) in pediatric patients aged 7–17 years with IBS-C demonstrated a low incidence of diarrhea and favorable tolerability through 52 weeks of treatment. FDA approval for this population was granted on November 5, 2025, supported by extrapolated adult efficacy data and a 12-week pediatric trial. In an ongoing phase 3 study, 98 patients received once-daily linaclotide at 145 μg or 290 μg, with safety findings consistent with adult studies and no discontinuations due to adverse events.

Julie Khlevner, MD, AGAF, Reacts to the FDA Approval of Linaclotide for Pediatric IBS-C

Julie Khlevner, MD, AGAF, Associate Professor of Pediatrics at Columbia University Medical Center and Chair, NASPGHAN Neurogastroenterology and Motility Committee, discussed the FDA approval of linaclotide for children ≥7 years with IBS-C. She highlighted improvements in bowel movement frequency and abdominal pain, confirming the therapy’s tolerability and potential use by both pediatric gastroenterologists and general pediatricians. Khlevner also underscored the ongoing need for new pediatric therapeutics to address individual symptomatology.

Click here to watch Julie Khlevner offer thoughts on the linaclotide's FDA approval.

Discussing Safety, Tolerability of Tenapanor in Pediatric IBS-C Patients, with Thomas Wallach, MD

Interim data from the phase 3 R-ALLY trial and its open-label extension showed that tenapanor, a sodium/hydrogen exchanger isoform 3 (NHE3) inhibitor, was safe and well-tolerated in adolescents with IBS-C. Wallach highlighted that no serious treatment-related adverse events occurred and that the safety profile was consistent with adult data. He noted the potential utility of tenapanor in managing pediatric constipation while emphasizing that efficacy data are still under investigation.

Click here to watch our full interview with Thomas Wallach, MD.

NASPGHAN 2025: Odevixibat Shows Sustained Pruritus and Bile Acid Improvements in FIC1 Deficiency

Post hoc analyses of PEDFIC 1 and PEDFIC 2 demonstrated that odevixibat provided sustained reductions in serum bile acids and improvements in pruritus in patients with FIC1 deficiency (PFIC1). Among 35 patients, long-term treatment up to 96 weeks maintained clinically meaningful improvements, supporting odevixibat’s durable benefit in managing both biochemical and symptomatic burdens of PFIC1.

Click here for more on odevixibat for FIC1 deficiency.

Odevixibat Improves Long-Term Quality of Life, Sleep in Patients with Alagille Syndrome

In patients with Alagille syndrome, odevixibat treatment led to long-term improvements in sleep and caregiver-reported quality of life (QoL). Data from the ASSERT and ASSERT-EXT studies showed sustained improvements across multiple sleep parameters and Pediatric Quality of Life Inventory scores over 96 weeks of therapy. These findings reinforce odevixibat’s impact on both symptomatic relief and overall patient well-being, complementing previous data on pruritus reduction in cholestatic liver disease.

Click here for more on odevixibat's long-term QoL and sleep improvement data.

Articles

The 2025 NASPGHAN Annual Meeting showcased significant advancements in pediatric gastroenterology, hepatology, and nutrition. Key topics included the geographic prevalence of Helicobacter pylori in children with digestive diseases, the FDA approval of linaclotide for pediatric IBS-C, and the safety of tenapanor in adolescents. Odevixibat demonstrated sustained benefits in managing FIC1 deficiency and Alagille syndrome, improving pruritus, bile acid levels, sleep, and quality of life. These findings highlight the ongoing progress in understanding and treating pediatric digestive disorders, emphasizing the importance of tailored therapeutic approaches.

HCPLive highlights key pediatric gastroenterology updates from NASPGHAN 2025, with continuing coverage to follow.

HCPLive Coverage Recap: NASPGHAN 2025 Annual Meeting

Nadia Ovchinsky, MD | Image credit: NYU Langone Health

Pooled long-term data from the phase 3 ASSERT (NCT04674761) and ASSERT-EXT (NCT05035030) studies showed that treatment with odevixibat led to sustained improvements in sleep and caregiver-reported quality of life (QoL) in patients with Alagille syndrome (ALGS). The results were presented at the 

 and authored by Nadia Ovchinsky, MD, Pediatric Gastroenterology and Hepatology, Hassenfeld Children's Hospital, NYU Langone, New York, NY, and colleagues.

Odevixibat on Long-Term Improvements in Sleep and Quality of Life

Patients with Alagille syndrome frequently experience severe pruritus, disrupted sleep, and reduced quality of life. Odevixibat, a selective ileal bile acid transport inhibitor, has shown efficacy in reducing cholestatic pruritus in this population. In this pooled analysis, long-term outcomes from up to 96 weeks of treatment were evaluated for sleep parameters and caregiver-assessed QoL measures.

In the ASSERT trial, patients received 24 weeks of placebo or odevixibat 120 µg/kg/day; study completers were eligible for ASSERT-EXT, during which patients received odevixibat for an additional 72 weeks. Endpoints included observer-reported sleep parameters and caregiver-assessed Pediatric Quality of Life Inventory (PedsQL) scores. 

A total of 52 patients with a median age of 5.7 years (1.0-15.5) received odevixibat across both studies. 

“Patients had significant improvements in 6 of 7 Observer-Reported Outcome (ObsRO) sleep parameters from baseline (BL) up to weeks 93−96 and a numerical reduction in days taking medication to induce sleep," the study authors wrote. Caregiver-reported PedsQL scores “also showed numerical improvements from BL up to week 96 with odevixibat.”

Odevixibat Shows Sustained Pruritus and Bile Acid Improvements in FIC1 Deficiency

According to the authors, “Long-term odevixibat given for up to 96 weeks improved multiple sleep parameters and caregiver-reported QoL in patients with ALGS; data support long-term improvements in pruritus seen with odevixibat.”

Specifically, the following improvements in Mean ObsRo sleep parameters were demonstrated from baseline (n = 50) to week 93-96 (n = 31).

Days seeing blood due to scratching: 35.2% at baseline vs 4.7% at week 93-96

Days needing help falling asleep: 56.5% at baseline vs 8.8% at week 93-96

Days with soothing: 64.4% at baseline vs 14.5% at week 93-96

Days sleeping with caregiver: 43.2% vs 4.6%

Number of awakenings: 3.5 at baseline vs 0.6 at week 93-96

Days taking medication to sleep: 29.7% vs 18.1% 

Daytime tiredness (score): 2.1 at baseline vs 0.9 at week 93-966

Odevixibat received FDA approval to treat cholestatic pruritus in patients aged 12 months and older on June 13, 2023. Approval was based on the ASSERT data through 24 weeks, where more than 90% of patients were responders to pruritus. Additionally, no patients discontinued the study, and 96% of patients were rolled into the open-label extension.

Ovchinsky N, Aumar M, Baker A, et al. LONG-TERM QUALITY OF LIFE OUTCOMES FOR PATIENTS WITH ALAGILLE SYNDROME TREATED WITH ODEVIXIBAT: POOLED RESULTS FROM PHASE III, RANDOMIZED, DOUBLE-BLIND ASSERT AND OPEN-LABEL ASSERT-EXT STUDIES. Abstract. Presented at: 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

Pooled data from the ASSERT and ASSERT-EXT studies indicate that odevixibat significantly improves sleep and caregiver-reported quality of life in Alagille syndrome patients over 96 weeks. Odevixibat, a selective ileal bile acid transport inhibitor, effectively reduces cholestatic pruritus, leading to enhanced sleep parameters and quality of life. The study involved 52 patients, with notable improvements in sleep disturbances and reduced need for sleep-inducing medication. Odevixibat received FDA approval in 2023 for treating cholestatic pruritus in patients aged 12 months and older, based on these findings.

Data presented at NASPGHAN 2025 revealed odevixibat demonstrated sustained improvements in sleep and caregiver-reported QOL in patients with Alagille syndrome through 96 weeks.

Odevixibat Improves Long-Term Quality of Life, Sleep in patients with Alagille Syndrome

Henkjan Verkade | Image credit: University of Groningen

New long-term findings from a post hoc analysis of the phase 3 PEDFIC 1 (NCT03566238) and PEDFIC 2 (NCT03659916) studies demonstrated sustained reductions in serum bile acids (sBA) and improvements in pruritus among patients with FIC1 deficiency (PFIC1) treated with odevixibat. Data were presented at the 

 Annual Meeting in Chicago, with the abstract authored by Henkjan Verkade, Pediatric Gastroenterology-Hepatology, Department of Pediatrics, University of Groningen, Beatrix Children's Hospital−University Medical Centre Groningen, Groningen, Netherlands, and colleagues. 

Odevixibat was approved on July 20, 2021, by the FDA, as well as in Europe, as the first drug treatment option for patients living with PFIC aged 3 months and older.

At the time, approval was based on pruritus improvement from baseline at 24 weeks. 

"We have now characterized the responders to ODX with FIC1 deficiency (PFIC1), separately for sBA and pruritus," wrote the study investigators.

Characterizing response in FIC1 deficiency


The post hoc analysis evaluated outcomes in patients with FIC1 deficiency treated with odevixibat (40 or 120 µg/kg/day) in PEDFIC 1 or PEDFIC 2 who achieved an sBA or pruritus response at Week 24 of treatment. sBA response was defined as “≥70% reduction in fasting sBA from baseline (BL) or sBA ≤70 μmol/L.” Pruritus response was defined as “a ≥1-point drop in observer-reported (ObsRO) scratching score (0–4 scale) from BL," wrote the study authors. 

In all, 35 patients with FIC1 deficiency were included. At Week 24 of odevixibat treatment, 5 patients were sBA responders and 14 were pruritus responders. According to study results, "10 of the 14 pruritus responders had a pruritus response independent of an sBA response, and 15 patients had either sBA or pruritus response, or both." 

At 96 weeks, analysis demonstrated sustained reductions in sBA and/or pruritus. 

Long-term outcomes with odevixibat treatment


According to the authors, “Patients with FIC1 deficiency who responded to odevixibat treatment at Week 24 experienced rapid improvements in pruritus and reductions in sBA that were sustained with long-term treatment.” Overall, “Forty percent (n=14/35) of patients with FIC1 deficiency achieved a sustained, clinically relevant improvement in pruritus; 10/14 of these achieved a pruritus response without fulfilling the stringent criteria for an sBA response," the authors concluded. 

These findings reinforce odevixibat’s durable benefit for managing both biochemical and symptomatic burdens in PFIC1, supporting its continued use and evaluation across progressive familial intrahepatic cholestasis types.

Verkade H, Thompson R, Artan R, et al. ODEVIXIBAT TREATMENT IN PATIENTS WITH FIC1 DEFICIENCY: SUSTAINED EFFICACY, PARTICULARLY IN PRURITUS, IN AN INTEGRATED ANALYSIS OF RESPONDERS (PEDFIC 1 AND PEDFIC 2). Abstract. Presented at: 2025 NASPGHAN Annual Meeting. November 5-9, 2025. Chicago, Illinois.

U.S. FDA approves Bylvay for patients living with cholestatic pruritus due to Alagille syndrome. Ipsen. Press release. Published June 13, 2023. Accessed November 7, 2025. https://www.ipsen.com/press-releases/u-s-fda-approves-bylvay-for-patients-living-with-cholestatic-pruritus-due-to-alagille-syndrome/

Yi S, Kim I, Hager R, Strazzeri MM, Garrard L, Matsubayashi T, Mehta R. Food and Drug Administration Approval Summary: Odevixibat (Bylvay) for the Treatment of Pruritus With Progressive Familial Intrahepatic Cholestasis. 

. 2024 Nov 29;4(4):100596. doi:10.1016/j.gastha.2024.100596. PMID: 40454003; PMCID: PMC12126724.

New long-term findings from the PEDFIC 1 and PEDFIC 2 studies highlight the sustained efficacy of odevixibat in reducing serum bile acids (sBA) and improving pruritus in patients with FIC1 deficiency (PFIC1). The analysis showed that 40% of patients achieved a clinically relevant improvement in pruritus, with some experiencing benefits independent of sBA response. These results underscore odevixibat's durable benefits in managing both biochemical and symptomatic burdens in PFIC1, supporting its continued use and evaluation across different types of progressive familial intrahepatic cholestasis.

Long-term analysis of the PEDFIC studies presented at NASPGHAN 2025 demonstrated sustained reductions in bile acids and pruritus with odevixibat in FIC1 deficiency.

The North American Society for Pediatric Gastroenterology, Hepatology and Nutrition (NASPGHAN) is holding its Annual Meeting from November 5–8, 2025, at the Sheraton Grand Chicago in Chicago, Illinois. Over the course of this four-day conference, pediatric gastroenterologists, hepatologists, nutrition specialists, and leading experts will gather to share the latest data, clinical updates, and evidence-based discussions across gastrointestinal, liver, and nutritional disorders in children.

Founded in 1972, NASPGHAN is the only society in North America—and the largest worldwide—dedicated to advancing research, education, and clinical practice in pediatric gastroenterology and nutrition. The meeting provides attendees with an opportunity to explore the latest findings, enhance clinical proficiency, and engage in expert discussions focused on improving outcomes in pediatric patients.

will be on-site to provide interviews with session presenters, daily highlights of new research, and practical coverage throughout the meeting.

Helicobacter Pylori Infection and Immune-Mediated Digestive Diseases in Children of the Americas: A Cross-Sectional Study of Comparative Prevalence

: Silvana Bonilla, Jose Vera, Ailim Carias, Carlos Cuadros, Michelle Higuera, Juan Pablo Riveros Lopez, Natali Gonzalez Rozo, Gloria Toscano, Ana Beatriz Munoz, Idalmis Aguilera, Enju Liu, Paul Harris


: This study assessed the prevalence of Helicobacter pylori infection (HPI) in children with newly diagnosed immune-mediated digestive diseases (IMDD). While HPI eradication in adults helps prevent complications, the role in children remains unclear. The session will explore comparative prevalence data across the Americas and discuss implications for pediatric evaluation of IBD, celiac disease, and eosinophilic esophagitis.

Safety and Tolerability of Tenapanor in Pediatric Patients with Irritable Bowel Syndrome With Constipation: An Analysis of Blinded Safety Data From a Phase 3 Study and Its Open-Label Extension

: Nastassja Williams, Thomas Wallach, Mihaela Ringheanu, Ana Roig Cantisano, Yang Yang, Karishma Raju, Jocelyn Tabora, Susan Edelstein


: This session presents preliminary, blinded safety data from the Phase 3 R-ALLY study and its open-label extension assessing tenapanor in pediatric patients with IBS-C aged 12–17 years. Attendees will learn about early safety and tolerability findings for this first-in-class, minimally absorbed therapy and its potential role in pediatric gastrointestinal care.

Characteristics Associated With Response to Teduglutide Treatment in Children With Short Bowel Syndrome–Associated Intestinal Failure: A Post Hoc Analysis of Long-Term Extension Studies

: Valeria Cohran, Beth Carter, Samuel Kocoshis, Susan Hill, Pradeep Nazarey, Ian Robinson, Brian Terreri, Robert Venick, Danielle Wendel, Paul W Wales


: This session will examine patient characteristics associated with response to teduglutide in children with SBS-IF, including achievement of consistent response and sustained enteral autonomy. Attendees will gain insights into factors that may guide clinical decision-making and optimize long-term outcomes for children requiring parenteral nutrition.

Therapeutic Trial of Sucraid® (Sacrosidase) for Alleviating Gastrointestinal Symptoms in Pediatric Subjects Stratified by Duodenal Sucrase Activity Levels

: Tanaz Danialifar, Jonathan Markowitz, Eduardo Rosas-Blum, Mario Tano, Melissa Van Arsdall, Angela Shannon, Youhanna Al-Tawil, Mary Lowry, Devendra Mehta, Daniel Gelfond, Adrian Miranda, Namrata Patel-Sanchez, Rohit Kohli, Craig Friesen, Runa Watkins, Molly O’Gorman, Thomas Sferra, Lesley Small-Harary, Barbara Verga, Kevin Watson, David Gremse, Christopher Hayes, Hillary Bashaw, Aldo Maspons, Shikib Mostamand, Miguel Saps, Maryam Shambayati, Julie Khlevner, Uwe Blecker, Stephanie Oliveira, Shaija Kutty


: This exploratory Phase 4 study investigated the effect of a 7-day sacrosidase trial on gastrointestinal symptoms in pediatric patients with suspected congenital sucrase-isomaltase deficiency (CSID) across a spectrum of sucrase activity. The session will discuss therapeutic responses by baseline sucrase activity, symptom frequency, and potential modifying effects of lactase deficiency.

Crossroads Between Celiac Disease and Other Autoimmune Conditions

: Mallon will describe associations between celiac disease and other autoimmune conditions in children, exploring potential mechanisms linking celiac disease with the development of additional autoimmune disorders.

Optimizing Nutrition in Cholestatic Liver Disease: A Collaborative Approach

: This session will review nutritional deficiencies and sarcopenia in children with cholestatic liver disease. Attendees will learn practical strategies for nutritional assessment, surveillance, and supplementation to optimize care in this patient population.

 team will deliver comprehensive updates on-site, along with exclusive interviews and recaps of sessions directly from the meeting.  Stay tuned for more throughout the week, and

 click here to view our continuing coverage from Chicago.

Editor's note: This summary was edited with the help of AI tools

The NASPGHAN Annual Meeting, scheduled for November 5–8, 2025, in Chicago, will convene pediatric gastroenterologists, hepatologists, and nutrition specialists to discuss advancements in pediatric gastrointestinal, liver, and nutritional disorders. Founded in 1972, NASPGHAN is the largest society dedicated to pediatric gastroenterology and nutrition. Key sessions will cover topics such as Helicobacter pylori infection, tenapanor safety in IBS-C, teduglutide response in SBS-IF, sacrosidase trial in CSID, celiac disease and autoimmune conditions, and nutrition in cholestatic liver disease. HCPLive will provide on-site coverage and interviews.

This preview of the 2025 NASPGHAN Annual Meeting highlights sessions and expert discussions on pediatric gastroenterology, hepatology, and nutrition covered by HCPLive.