Category Archives: Uncategorized

Lots of Room to Improve with H pylori Treatment

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Briefly noted: A recent survey study (N Du et al. JPGN Reports: 2021; 2: p e033. doi: 10.1097/PG9.0000000000000033. Full Text: Assessment of Community Pediatric Providers’ Approach to Children With Helicobacter pylori) found that pediatric providers had poor knowledge and/or adherence to pediatric H pylori guidelines.

Key findings:

  • Over a third of the respondents reported incorrectly testing patients for H. pylori while they were taking proton pump inhibitors.
  • 17% (n=17) incorrectly preferred blood serology as testing modality
  • 63% (n=64) relied on symptom resolution as indication of cure

My take: It would be interesting to compare pediatric gastroenterology provider responses to general pediatric providers. It is likely that a much higher percentage would be following established guidelines. One area of the guidelines that I think should be changed would be encouraging increased use of quadruple therapy in children, especially if resistance testing is not performed; this change would better align with adult guidelines. In adults, quadruple therapy has been associated with increased cure rates.

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Data on Immobilized Lipase Cartridge for Patients with Cystic Fibrosis

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Full text: M Sathe et al. JPGN 2021; 72: 18-23. Evaluation of the Effectiveness of In-line Immobilized Lipase Cartridge in Enterally Fed Patients With Cystic Fibrosis

Background: Traditional pancreatic enzyme replacement therapy is not designed for use with enteral feedings. “Only 1 FDA-approved PERT (PERTZYE, Cheisi, Inc.) has a package insert with instructions on how to deliver the contents of the lowest dose capsule (4000 USP lipase unit) through gastrostomy tubes 14 French or larger…Two recently published studies demonstrated the safety, tolerability, and effect on FA absorption of a new enzyme strategy to aid fat digestion with continuous enteral feedings, a single use digestive cartridge containing immobilized lipase (RELiZORB; Alcresta Therapeutics, Newton, MA). The cartridge connects in-line with an enteral feeding set. As enteral formula flows through the cartridge, immobilized lipase enzyme hydrolyzes intact triglyceride fats within the formula into more absorbable forms, whereas the lipase is retained within the cartridge.”

Key findngs:

  • Weight percentiles reached 50% in 18%, 25.5%, and 28.9% of patients at 0, 6, and 12, respectively.
  • BMI reached 50% in 37.1%, 49.1%, and 50.0% in patients at 0, 6, and 12 months, respectively.

My take: “Immobilized lipase cartridge use demonstrated statistically significant improvements in growth in patients with cystic fibrosis requiring enteral feedings.” Newer and more effective therapies for Cystic Fibrosis may decrease the need for enteral supplementation along with lipase cartridge.

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Does It Make Sense to Look for Celiac Disease in Children with Functional Constipation?

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A recent study (AC Fifi et al. J Pediatr 2020; 227: 77-80.Full text PDF: Celiac Disease in Children with Functional Constipation: A School-Based Multicity Study) shows that celiac disease was not more prevalent in Colombian children with functional constipation(n=203) than in matched healthy controls (n=419). Patients were recruited from public schools.

Key finding:

  • The overall prevalence of celiac disease in the entire cohort was 0.6%. Of those with functional constipation, 1 (0.5%) was diagnosed with celiac disease, and 3 (0.7%) of the control patients

The authors note that some prior publications (references 11 and 12) have found a slight increase risk of celiac disease in children with constipation.

My take: In children with functional constipation, the yield from testing for celiac disease is very low and probably not significantly greater than the general population. In children with irritable bowel syndrome (which is often confused with constipation), the yield is probably a bit higher.

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Chicago

A New FDA Warning for Tofacitinib

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2/4/21: FDA: Initial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)

“The U.S. Food and Drug Administration (FDA) is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to another type of medicine called tumor necrosis factor (TNF) inhibitors. FDA required the safety trial, which also investigated other potential risks including blood clots in the lungs and death. Those final results are not yet available….

Patients should not stop taking tofacitinib without first consulting with your health care professionals, as doing so may worsen your condition. Talk to your health care professionals if you have any questions or concerns.”

Related blog post: FDA Warning on Tofacitinib (July 2019)

Growth in Inflammatory Bowel Disease: Better Late Than Never

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Briefly noted: N Gupta et al. Inflamm Bowel Dis 2020; 26: 1880-1889. Continued Statural Growth in Older Adolescents and Young Adults With Crohn’s Disease and Ulcerative Colitis Beyond the Time of Expected Growth Plate Closure

In this retrospective observational longitudinal cohort study with 3007 patients with IBD from the ImproveCareNow Network, the authors found a high rate of continued linear growth after expected growth plate closure (15 years in females, 17 years in males).

Key findings:

  • 80% manifested continued growth beyond the time of expected growth plate closure, more commonly in CD (81%) than UC (75%; P = 0.0002)
  • Median height gain was greater in males with CD (1.6 cm) than in males with UC (1.3 cm; P = 0.0004), and in females with CD (1.8 cm) than in females with UC (1.5 cm; P = 0.025)

My take: This study provides additional information about delayed skeletal maturation in the pediatric population with inflammatory bowel disease. Interestingly, the rate of continued growth with ulcerative colitis was nearly as high as with Crohn’s disease.

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Statin Use May Help in Fatty Liver Disease

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J Lee et al. The American Journal of Gastroenterology: January 2021 – Volume 116 – Issue 1 – p 116-124. Full text link: Effects of Statin Use on the Development and Progression of Nonalcoholic Fatty Liver Disease: A Nationwide Nested Case-Control Study,

Using more than 11 million subjects enrolled in Nationwide Korean database, the authors explored the associations between statin use and fatty liver disease in adults (20 yrs or older).

Key findings:

  • The use of statin was associated with a reduced risk of NAFLD development (adjusted odds ratio [AOR] 0.66; 95% confidence interval [CI] 0.65–0.67). NAFLD was diagnosed by calculating fatty liver index (FLI).
  • The use of statins reduced the risk of significant liver fibrosis (AOR 0.43; 95% CI 0.42–0.44). Fibrosis was based on a BARD score ≥ 2.

The effects of statins may be mediated by anti-inflammatory and antifibrotic actions, which have been evident in experimental models of chronic liver disease.

My take: Statin use appears beneficial in patients with NAFLD. Since dyslipidemia is frequent in patients with NAFLD, there should be a low threshold for using statin therapy.

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Does Reflux Therapy Help Chronic Throat Symptoms? (Probably Not)

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A recent study (J O’Hara et al. BMJ 2021;372:m4903. Full text: Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial) will probably be another thorn in the side of our ENT colleagues who frequently assert that reflux is likely causing a persistent sore throat. This study is likely to influence empiric treatment by GI physicians as well.

Methods:

  • Random blinded allocation (1:1) to either 30 mg lansoprazole (n=172) twice daily or matched placebo (n=174) twice daily for 16 weeks of patients with persistent throat symptoms.
  • Eligible patients had persistent (>6 weeks) unexplained throat symptoms—principally hoarseness, throat pain, globus sensation, throat clearing, postnasal secretions or excess mucus, cough, or choking sensation
  • Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score.

Key finding:

  • No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up.
  • Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms. Furthermore, “no trends were in favour of lansoprazole.”
  • Limitation: “Our trial could be criticised for lacking any objective measure of GORD within the methodology or for employing any such test as an inclusion criteria. However, we did address the use of PPIs in an empirical setting, which was a near universal practice at the time of our study.”

My take (borrowed in part from authors): “No evidence supports the empirical use of PPIs to treat persistent throat and voice symptoms.” Despite this finding, “old habits die hard” and I predict that it will be a long time before this finding is widely adopted into clinical practice.

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STRIDE II -Updated Crohn’s Disease Target Goals

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From Tauseef Ali’s Twitter Feed — a summary slide of Crohn’s disease targets for both pediatric and adult patients and a slide showing typical response/remission/healing times to medications.

From the following article: D Turner et al. Gastroenterology (12/31/20, Online Ahead of Print): DOI: 10.1053/j.gastro.2020.12.031 STRIDE-II: An Update on the Selecting Therapeutic Targets in Inflammatory Bowel Disease (STRIDE) Initiative of the International Organization for the Study of IBD (IOIBD): Determining Therapeutic Goals for Treat-to-Target strategies in IBD

Recommendations were based on a systematic review of the literature and iterative surveys of 89 IOIBD members, recommendations were drafted and modified in two surveys and two voting rounds.

Vaccination Recommendations for IBD Patients

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From COVID-19 Memorial in Washington D.C. 1/19/21

Siegel CA, Melmed GY, McGovern DP, et al. Full text link: SARS-CoV-2 vaccination for patients with inflammatory bowel diseases: recommendations from an international consensus meeting Gut  Published Online First: 20 January 2021. doi: 10.1136/gutjnl-2020-324000

From David Rubin’s Twitter Feed

In the article, they note “the exception is for any live-attenuated virus vaccines or replication-competent viral vector vaccines that come to market.” Currently, all of the vaccines are inactivated (not live-attenuated).

These recommendations apply to approved populations which currently do not include pediatric patients or patients who are pregnant.

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From Children’s Healthcare of Atlanta: