Evidence map›Paper›PMID 30074573›Full record

Trial reportJournal of pediatric gastroenterology and nutrition2018

Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding.

John Stevens, Colby Wyatt, Perry Brown, Dhiren Patel, Danica Grujic, Steven D Freedman

2 registry-linked trialsOpen access · hybridAbstract readClinical TrialMulticenter Study
In one paragraph

Trial report in Journal of pediatric gastroenterology and nutrition, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 16 papers.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed
3.8field-weighted citation impact, top 6% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05710315 naactive not recruitingnot on this mapstarted 2025, after this paper: background citation

Single-center, Proof of Concept, Prospective Study Evaluating the Utility of RELiZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

TypeinterventionalSponsorInova Health Care ServicesRan2025 to 2026Enrolled32ConditionsMulti Organ Failure, Exocrine Pancreatic InsufficiencyArmsRELiZORB™, Placebo
NCT06691893 phase3recruitingnot on this mapstarted 2025, after this paper: background citation

A Randomized Controlled Trial to Evaluate the Efficacy of Immobilized Lipase (RELiZORB) During Enteral Nutrition in Patients With Exocrine Pancreatic Insufficiency Secondary to Acute Pancreatitis

TypeinterventionalSponsorMassachusetts General HospitalRan2025 to 2027Enrolled60ConditionsExocrine Pancreatic Insufficiency (EPI), PancreatitisArmsRELiZORB
3 · Its place in the literature

Who cites it

16 citing papers in PubMed, 51 citations in OpenAlex.

  1. Trial
  2. Article
  3. Article
  4. Article
  5. Review
  6. Alterations in exocrine pancreatic function after acute pancreatitis.Pancreatology : official journal of the International Association of Pancreatology (IAP) ... [et al.] · 2024
    Review
  7. Article
  8. Exocrine Pancreatic Insufficiency in Children - Challenges in Management.Pediatric health, medicine and therapeutics · 2023
    Review
  9. Review
  10. Article
  11. Improvements in anthropometric measures and gastrointestinal tolerance in patients with cystic fibrosis by using a digestive enzyme cartridge with overnight enteral nutrition.Nutrition in clinical practice : official publication of the American Society for Parenteral and Enteral Nutrition · 2022
    Article
  12. Review
  13. Article
  14. Article
  15. Article
  16. Innovations in Pancreatic Enzyme Replacement Therapy for Enterally Fed Patients With Pancreatic Cancer.Gastroenterology nursing : the official journal of the Society of Gastroenterology Nurses and Associates
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 5 institutions in 1 country.

John StevensRiley Hospital for Children, Indianapolis, IN.
Colby WyattMaine Medical Center, Portland, ME.
Perry BrownSt. Luke's Health System, Boise, ID.
Dhiren PatelDivision of Gastroenterology and Department of Pediatrics Saint Louis University School of Medicine, St. Louis, MO.
Danica GrujicAlcresta Therapeutics, Inc, Warren, NJ.
Steven D FreedmanDepartment of Medicine and Division of Translational Research, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA.
Beth Israel Deaconess Medical Center · USMaine Medical Center · USRiley Hospital for Children · USSaint Louis University · USSaint Luke's Health System · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesPancreatic insufficiency (PI) and malabsorption of fats lead to reduced caloric intake, inability to maintain weight, and increased gastrointestinal symptoms. Thus, enteral nutrition (EN) is used in patients with cystic fibrosis (CF) and poor nutritional status. The current study evaluated safety, tolerability, and improvement of fatty acid (FA) status in red blood cell (RBC) membranes, a marker of long-term FA absorption, with an in-line digestive cartridge (RELiZORB) that hydrolyzes fat in enteral formula.

methodsPatients with CF receiving EN participated in a multicenter, 90-day open-label study during which RELiZORB was used with overnight EN. The primary endpoint was change over time in RBC uptake of docosahexaenoic acid (DHA)+ eicosapentaenoic acid (EPA). Gastrointestinal symptoms were collected to evaluate safety and tolerability. Several clinical and anthropometric parameters were also assessed throughout the study.

resultsA total of 36 subjects completed the study with a mean age of 13.8 years, body mass index of 17.7 and 6.2 years mean use of overnight EN. Fat absorption significantly improved as shown by increased RBC levels of DHA+EPA, improved ω-6/ω-3 ratio, and increased plasma levels of DHA+EPA. RELiZORB use was not associated with any unanticipated adverse events.

conclusionsRELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma. This is the first prospective study to show EN can improve FA abnormalities in CF. Because improvement in omega-3 levels has been shown to help pulmonary and inflammatory status as well as anthropometric parameters in CF, RELiZORB may have important long-term therapeutic benefits in patients with CF.

Indexed as

AdolescentBody Mass IndexChildCystic FibrosisEnteral NutritionErythrocyte CountErythrocytesFatty AcidsFemaleHumansMaleProspective StudiesTime FactorsTreatment OutcomeFatty Acids

Identifiers

PMID30074573
PMCPMC6155360
OpenAlexW2887525724

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.