Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition: A Randomized Controlled Trial

Bartels, Rosalie H.; Bourdon, Céline; Potani, Isabel; Mhango, Brian; Brink, Deborah A. van den; Mponda, John; Kobold, Anneke C. Muller; Bandsma, Robert; Hensbroek, Michaël Boele van; Voskuijl, Wieger

doi:10.1016/j.jpeds.2017.07.013

Cited by 15 publications

(23 citation statements)

References 41 publications

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“…Individual studies' quality scores are shown in Supplementary Data 3. Twelve studies had an overall quality rating considered to be high (16,59,(67)(68)(69)(72)(73)(74)(75)(76)78) , fifteen studies were rated as medium (39,44,45,55,58,62,65,66,70,71,77,79,80,82,83) , seventeen studies were rated as low (17,18,(23)(24)(25)27,29,30,35,40,43,46,52,53,57,60,81) and the remaining twenty-four as very low (19)(20)(21)(22)26,28,(31)(32)…”

Section: Study Quality Assessmentmentioning

confidence: 99%

“…Studies using catheters and collecting duodenal fluid before and after simulation measured various enzymes, including amylase, lipase, phospholipase, trypsin and chymotrypsin, as well as bicarbonate and electrolytes (19,(22)(23)(24)(25)(26)28,48,49) . Recent studies assessed faecal elastase, which is low in pancreatic insufficiency (16,17,27,50) , or blood levels of enzymes such as trypsinogen, amylase or lipase which may be either high or low in pancreatic disorders (18,20,21) . One study measured pancreas head size in children using ultrasound (21) and another measured D-xylose and triglyceride absorption (50) .…”

Section: Definitions Of Exocrine and Endocrine Pancreas Outcomesmentioning

confidence: 99%

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Association of postnatal severe acute malnutrition with pancreatic exocrine and endocrine function in children and adults: a systematic review

et al. 2022

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Severe acute malnutrition may lead both concurrently and subsequently to malabsorption and impaired glucose metabolism from pancreatic dysfunction. We conducted a systematic review to investigate the associations of current and prior postnatal wasting malnutrition with pancreatic endocrine and exocrine functions in humans. We searched PubMed, Google Scholar, Web of Science, and reference lists of retrieved articles, limited to articles in English published before February 1, 2022. We included 68 articles, mostly cross-sectional or cohort studies from 29 countries including 592,530 participants, of which 325,998 were from a single study. Many were small clinical studies from decades ago and rated poor quality. Exocrine pancreas function, indicated by duodenal fluid or serum enzymes, or fecal elastase, was generally impaired in malnutrition. Insulin production was usually low in malnourished children and adults. Glucose disappearance during oral and intravenous glucose tolerance tests was variable. Upon treatment of malnutrition, most abnormalities improved but frequently not to control levels. Famine survivors studied decades later showed ongoing impaired glucose tolerance with some evidence of sex differences. The similar findings from anorexia nervosa, famine survivors, and poverty- or infection-associated malnutrition in low- and middle-income countries (LMICs) lend credence to results being due to malnutrition itself. Research using large, well-documented cohorts and considering sexes separately, is needed to improve prevention and treatment of exocrine and endocrine pancreas abnormalities in LMICs with a high burden of malnutrition and diabetes.

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Section: Study Quality Assessmentmentioning

confidence: 99%

Section: Definitions Of Exocrine and Endocrine Pancreas Outcomesmentioning

confidence: 99%

Association of postnatal severe acute malnutrition with pancreatic exocrine and endocrine function in children and adults: a systematic review

et al. 2022

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“…EPI has been described in children with severe acute malnutrition (SAM), more so in the edematous form (kwashiorkor) of SAM in resource‐limited settings . Severe malnutrition has been associated with both structural (atrophy of pancreatic acini with fibrous tissue replacement, decrease in secretory granules) and functional (decreased lipase and trypsin secretion) changes resulting in EPI .…”

Section: Etiopathogenesis and Epidemiology Of Epi In Childrenmentioning

confidence: 99%

Management of Exocrine Pancreatic Insufficiency in Children

2019

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The diagnosis of exocrine pancreatic insufficiency (EPI) can be difficult, as symptoms may be nonspecific. A delayed diagnosis of EPI can negatively impact health through poor weight gain, impaired growth, and malabsorption of nutrients. Because of active growth and development, children are more vulnerable to the consequences of untreated EPI. Pancreatic enzyme replacement therapy is the cornerstone of management and offers both symptomatic relief and improvement in clinical outcomes. Additionally, a high-energy diet with unrestricted fat and supplementation with fat-soluble vitamins is often required to optimize growth and prevent nutrition deficiencies. Cystic fibrosis (CF) is the most common condition in children that causes EPI, and improvement in nutrition management is associated with improved pulmonary function and increased survival. Currently, the management of other conditions leading to EPI in children is not well studied, and inferences from the CF literature are often necessary in caring for these patients. (Nutr Clin Pract. 2019;34(suppl 1):S27-S42)

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“…However, severely malnourished children with medical complications still require hospitalisation,9 and often fail to respond to treatment 10. Inpatient mortality among children with complicated SAM remains up to 38% 5 11–13. Even after discharge, children have a poor prognosis, with up to 42% mortality documented over the subsequent year 6.…”

Section: Background and Rationalementioning

confidence: 99%

TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol

et al. 2019

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IntroductionSevere acute malnutrition (SAM) in children in many countries still carries unacceptably high mortality, especially when complicated by secondary infection or metabolic derangements. New therapies are urgently needed and we have identified mucosal healing in the intestine as a potential target for novel treatment approaches.Methods and analysisThe TAME trial (Therapeutic Approaches for Malnutrition Enteropathy) will evaluate four novel treatments in an efficient multi-arm single-blind phase II design. In three hospitals in Zambia and Zimbabwe, 225 children with SAM will be randomised to one of these treatments or to standard care, once their inpatient treatment has reached the point of transition from stabilisation to increased nutritional intake. The four interventions are budesonide, bovine colostrum or N-acetyl glucosamine given orally or via nasogastric tube, or teduglutide given by subcutaneous injection. The primary endpoint will be a composite score of faecal inflammatory markers, and a range of secondary endpoints include clinical and laboratory endpoints. Treatments will be given daily for 14 days, and evaluation of the major endpoints will be at 14 to 18 days, with a final clinical evaluation at 28 days. In a subset of children in Zambia, endoscopic biopsies will be used to evaluate the effect of interventions in detail.Ethics and disseminationThe study has been approved by the University of Zambia Biomedical Research Ethics Committee (006-09-17, dated 9thJuly, 2018), and the Joint Research Ethics Committee of the University of Zimbabwe (24thJuly, 2019). Caregivers will provide written informed consent for each participant. Findings will be disseminated through peer-reviewed journals, conference presentations and to caregivers at face-to-face meetings.Trial registration numberNCT03716115.

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Pancreatic Enzyme Replacement Therapy in Children with Severe Acute Malnutrition: A Randomized Controlled Trial

Cited by 15 publications

References 41 publications

Association of postnatal severe acute malnutrition with pancreatic exocrine and endocrine function in children and adults: a systematic review

Association of postnatal severe acute malnutrition with pancreatic exocrine and endocrine function in children and adults: a systematic review

Management of Exocrine Pancreatic Insufficiency in Children

TAME trial: a multi-arm phase II randomised trial of four novel interventions for malnutrition enteropathy in Zambia and Zimbabwe - a study protocol

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