Polyethylene Glycol Maintenance Treatment for Childhood Functional Constipation

Modin, Line; Walsted, Anne Mette; Dalby, Kasper; Jakobsen, Markus Due

doi:10.1097/mpg.0000000000002070

Cited by 18 publications

(24 citation statements)

References 33 publications

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“…Administration of the Hi PEG had the strongest effect on stool consistency but lower doses of PEG3350 and Mag also led to significant differences in stool consistency. Importantly, the lower dose of PEG3350 used in this study (1 g/kg) is similar to doses used in clinical practice and pediatric research studies (0.8–1 g/kg) (3,6–8). Thus, laxatives administered at clinically relevant doses, as well as at higher doses, led to significant differences in mouse stool consistency, but did not affect any of the behaviors tested.…”

Section: Discussionmentioning

confidence: 88%

“…Although the Food and Drug Administration (FDA) has approved PEG3350 to treat constipation in those 18 years and older, it is commonly used ''off label'' in children (1)(2)(3). Studies in children show that PEG3350 is efficacious in the treatment of constipation and superior to other laxatives (4)(5)(6)(7)(8). The North American and European Societies for Pediatric Gastroenterology, Hepatology, and Nutrition recommend PEG3350 as the first-line therapy for treatment of constipation in children (9).…”

mentioning

confidence: 99%

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Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Salman

Williams

Marte-Ortiz

et al. 2021

Journal of Pediatric Gastroenterology &Amp; Nutrition

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Objectives: Polyethylene Glycol 3350 (PEG3350) is a laxative commonly used to treat constipation in children. The Food and Drug Administration has received reports of increased anxiety, aggression, and obsessive-compulsive behaviors in children administered PEG3350. Thus, we assessed whether daily administration of PEG3350 leads to anxiety-like behavior in mice. Methods: Outbred CD-1 IGS mice were administered either a high or a low dose of PEG3350 via daily oral gavage for 2 weeks. As a laxative comparison and control, additional mice were given a high or low dose of magnesium citrate or vehicle (water). Weight and stool consistency were assessed after each gavage to determine laxative effectiveness. Anxiety-like behaviors were assessed using light/dark, open field, and elevated plus maze (EPM) tests at baseline, after 2 weeks of daily gavage, and after a 2 week washout in experiment 1, and after 2 weeks of daily gavage in experiment 2. Stool samples were collected for microbiome analysis in experiment 2 at baseline, after 2 weeks of daily gavage, and after 2 weeks washout. Results: PEG3350 and magnesium citrate significantly changed stool consistency, as well as microbiome alpha and beta diversity. Anxietylike behaviors were not, however, different in mice administered low or high doses of PEG3350 or magnesium citrate. Conclusions: Although changes in stool consistency and the gut microbiome occurred, administration of PEG3350 did not alter anxiety-like behaviors.

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Section: Discussionmentioning

confidence: 88%

mentioning

confidence: 99%

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Salman

Williams

Marte-Ortiz

et al. 2021

Journal of Pediatric Gastroenterology &Amp; Nutrition

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“…In contrast, in a study by Modin et al . (2018), on the use of PEG in maintenance treatment for childhood FC, the median time to the use of rescue medication in the control group, which discontinued use of PEG, was 27 days (range: 3–64 days) [ 26 ]. Therefore, lack of laxative use in our study, supports the benefits of study formulas for maintenance of good stooling parameters beyond the pharmacological treatment period.…”

Section: Discussionmentioning

confidence: 99%

The use of two Comfort Young Child Formulas in the dietary management of toddlers with functional constipation: a randomized controlled trial

Sevilla¹,

Hofman

Madero³

et al. 2022

BMC Pediatr

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Background Pharmacological intervention with laxatives is the conventional treatment for functional constipation (FC). Data to support the dietary management of FC is lacking. This study compared the efficacy of two Comfort young child formulas (YCFs) with regards to the maintenance of healthy stooling parameters in toddlers with a history of constipation. It was registered in the Netherlands Trial Registry [identifier: NL7420 (NTR7653)], registration date 20/09/2018. Methods Ninety-five healthy toddlers, aged 12 to 32 months, diagnosed with FC (Rome III criteria) were randomized to receive one of two study formulas after pharmacological treatment. For the first month of the intervention, subjects received a laxative in a decreasing maintenance dose alongside a test or control formula (maintenance phase). Subsequently, subjects only consumed formula for another month (post-maintenance phase). Stooling parameters were obtained weekly using the Bristol Stool Scale and the modified Rome III Questionnaire on Paediatric Gastrointestinal Symptoms for infants and toddlers. Differences in percentages of hard stools (primary outcome) and other stooling parameters were analysed using analysis of covariance and Chi-Square methods. Results Both formulas resulted in similar overall percentage of hard stools during the intervention period, respectively 5.02% in the test and 2.99% in the control group (n.s.). In the test group, percentages dropped from 7.11% at the end of the maintenance phase, to 3.92% at the end of the post-maintenance phase. In contrast, the percentage of hard stools in the control group was similar at the end of the maintenance (3.18%) and post-maintenance phase (2.83%; n.s.). No difference was found in the overall stool frequency between groups. At the end of the maintenance phase, only 22% and 19% of toddlers consuming the test and control formulae, respectively, met 2 or more of the criteria for FC. At the end of the study, this percentage of subjects decreased further to 9% in the test group, which tended to be lower compared to the 21% found in the control (p = 0.107). No laxative use was reported in either study group during the post-maintenance phase. Conclusion Both Comfort YCF support the maintenance of improved stooling over time in toddlers with a history of constipation. The percentage of subjects suffering from functional constipation tended to be lower after the intervention period when receiving the formula with intact protein.

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“…The reported side effects from these reports included: electrolyte abnormalities, abdominal pain, diarrhoea, nausea/vomiting, bloating/flatulence, and irritation of the anal area, bloating and gases or abdominal pain, allergy, raised ALT and one case with thirst, fatigue and nausea . One recent large study on clinical use of PEG reported one patient with headache as the only neurologic adverse effect while another fairly large randomised trial failed to document significant adverse reactions on long‐term maintenance therapy . A recent study has documented PEG metabolites in children on PEG and in those who were not.…”

Section: Discussionmentioning

confidence: 99%

Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers

et al. 2019

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Summary Background and aim To investigate the nature, origin and extent of reported neuropsychiatric side effects of polyethylene glycol 3350 (PEG, MiraLax©) leading to avoidance of this laxative by parents and caregivers. Methods We analysed (a) Federal Drug Administration (FDA) Adverse Effect Reporting System (AERS) data. (b) Google Search© and Google Trend© analysis of internet search trends of PEG side effects and (c) Surveys of US paediatric gastroenterologists. The data was analysed by descriptive statistics, chi squared tests with Benjamini‐Hochberg procedure. Results Between 2007 and 2017, 1564 adverse symptoms (AS) were reported on 645 children between the ages of 0‐21. Of these, 919 (58.75%) were neurological, 770 of these were neuropsychiatric (83.8%), such as anxiety, anger, abnormal behaviour, etc. As media reports for AS were released, we found (a) a spike in internet traffic related to PEG AS and (b) a marked increase in AERS reporting; chronologically coinciding with release of media reports on AS. The internet activity has remained above the baseline since then. Of 149 paediatric gastroenterologists surveyed, 25 (16.8%) recalled neuropsychiatric symptoms reported by parents, PEG refusal was reported by 63.3% (76/120), significantly more by those reporting neuropsychiatric symptoms (P = 0.03). Conclusions The PEG refusal reported by paediatric gastroenterologists was temporally related to an unprecedented and sustained spike of internet activity that immediately followed multiple media reports on PEG AS. It appears that negative public perception triggered by media reporting and amplified by internet activity has resulted in increased AERS reporting and parenteral refusal of PEG.

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Polyethylene Glycol Maintenance Treatment for Childhood Functional Constipation

Abstract: Maintenance treatment with PEG is significantly more effective than placebo in preventing relapse of constipation symptoms during long-term maintenance treatment in childhood FC. We therefore recommend that maintenance treatment commence after disimpaction.

Cited by 18 publications

References 33 publications

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

Polyethylene Glycol 3350 Changes Stool Consistency and the Microbiome but not Behavior of CD1 Mice

The use of two Comfort Young Child Formulas in the dietary management of toddlers with functional constipation: a randomized controlled trial

Probable neuropsychiatric toxicity of polyethylene glycol: roles of media, internet and the caregivers

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