PMID- 36821851
OWN - NLM
STAT- MEDLINE
DCOM- 20230426
LR  - 20230624
IS  - 1536-4801 (Electronic)
IS  - 0277-2116 (Print)
IS  - 0277-2116 (Linking)
VI  - 76
IP  - 5
DP  - 2023 May 1
TI  - Phase III Randomized Non-Inferiority Study of OSS Versus PEG + Electrolyte 
      Colonoscopy Preparation in Adolescents.
PG  - 652-659
LID - 10.1097/MPG.0000000000003745 [doi]
AB  - OBJECTIVES: Many protocols and preparations are used for bowel cleansing before 
      pediatric colonoscopy but few are based on scientific evidence. We evaluated 
      efficacy, safety, tolerability, and patient preference of oral sulfate solution 
      (OSS) at 75% of the adult dose versus polyethylene glycol (PEG)-electrolyte 
      solution in adolescents presenting for diagnostic colonoscopy. METHODS: Phase 
      III, randomized, evaluator-blinded, non-inferiority study of OSS and PEG in 
      adolescents aged 12-17 years. OSS and PEG were administered in 2 doses on the day 
      before colonoscopy. Primary endpoint included proportion of patients with 
      successful overall preparation (4-point scale). Secondary endpoints included 
      overall and segmental bowel cleansing (Boston Bowel Preparation Scale; BBPS), 
      completed colonoscopies, duration of examination, time to cecal intubation, 
      proportion of nasogastric tubes (NGTs), adverse events (AEs) and acceptability. 
      RESULTS: Successful cleansing was achieved in 71.4% and 79.0% of patients 
      receiving OSS and PEG, respectively [adjusted difference -7.61 (95% confidence 
      interval, CI, -18.45 to 3.24); P = 0.0907]. Segmental BBPS score for the left and 
      transverse colon were similar between treatment groups, but better for the right 
      colon with PEG than OSS [2.2 (95% CI, 2.0-2.4) and 1.9 (95% CI, 1.7-2.1), 
      respectively; P = 0.0015]. Significantly fewer OSS patients needed NGT placement 
      to ingest the whole solution [9/125 (7.2%)] than PEG patients [36/116 (31.0%); P 
      < 0.0001]. Treatment acceptability was significantly higher with OSS than PEG ( P 
      < 0.0001). Duration of examination, completed colonoscopies, and time to cecal 
      intubation were similar between preparations. Gastrointestinal AEs including 
      nausea, vomiting, abdominal pain, and distension were similar in both groups but 
      more patients receiving PEG had AEs assessed as incapacitating. CONCLUSIONS: 
      Non-inferiority of OSS to PEG was not demonstrated, but OSS was associated with a 
      lower requirement for NGT, better acceptability, and less frequent severe AEs 
      than with PEG.
CI  - Copyright (c) 2023 The Author(s). Published by Wolters Kluwer on behalf of European 
      Society for Pediatric Gastroenterology, Hepatology, and Nutrition and North 
      American Society for Pediatric Gastroenterology, Hepatology, and Nutrition.
FAU - Socha, Piotr
AU  - Socha P
AD  - From Children's Memorial Health Institute, Warsaw, Poland.
FAU - Posovszky, Carsten
AU  - Posovszky C
AD  - University-Children's Hospital, Zurich, Switzerland.
AD  - the Department for Pediatrics and Adolescent Medicine, University Medical Center 
      Ulm, Ulm, Germany.
FAU - Szychta, Monika
AU  - Szychta M
AD  - From Children's Memorial Health Institute, Warsaw, Poland.
FAU - Viscogliosi, Federica
AU  - Viscogliosi F
AD  - John Paul II Upper Silesian Child Health Centre, Katowice, Poland.
FAU - Martemucci, Luigi
AU  - Martemucci L
AD  - John Paul II Upper Silesian Child Health Centre, Katowice, Poland.
FAU - Grzybowska-Chlebowczyk, Urszula
AU  - Grzybowska-Chlebowczyk U
AD  - John Paul II Upper Silesian Child Health Centre, Katowice, Poland.
AD  - the Department of Paediatrics I, Faculty of Medical Science, Medical University 
      of Silesia, Katowice, Poland.
FAU - Perrot, Valerie
AU  - Perrot V
AD  - Ipsen Pharma, Boulogne-Billancourt, France.
FAU - Kornowski, Anne
AU  - Kornowski A
AD  - Ipsen Consumer HealthCare, Boulogne-Billancourt, France.
FAU - Benninga, Marc A
AU  - Benninga MA
AD  - Emma Children's Hospital, Amsterdam University Medical Centre, Amsterdam, The 
      Netherlands.
CN  - EASYKID Study Group
LA  - eng
SI  - ClinicalTrials.gov/NCT03008460
PT  - Clinical Trial, Phase III
PT  - Equivalence Trial
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20230222
PL  - United States
TA  - J Pediatr Gastroenterol Nutr
JT  - Journal of pediatric gastroenterology and nutrition
JID - 8211545
RN  - 0 (Cathartics)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - 0 (Sulfates)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Child
MH  - Humans
MH  - *Cathartics/adverse effects
MH  - Cecum
MH  - *Colonoscopy/methods
MH  - Polyethylene Glycols/adverse effects
MH  - Sulfates
PMC - PMC10097489
COIS- P.S. is principal investigator but reports no conflicts of interest in connection 
      with this manuscript. C.P. is principal investigator but reports no conflicts of 
      interest in connection with this manuscript (consultant for the following 
      companies: Takeda, AbbVie, Milupa-Nutricia). U.G-C. is principal investigator but 
      reports no conflicts of interest in connection with this manuscript. V.P. is an 
      employee of Ipsen Pharma. A.K. is an employee of Ipsen Consumer HealthCare. 
      M.A.B. is a consultant for Norgine, Coloplast, Mallinckrodt, Allergan, 
      FrieslandCampina, Danone, HIPP, and United Pharmaceuticals. The remaining authors 
      report no conflicts of interest.
EDAT- 2023/02/24 06:00
MHDA- 2023/04/25 06:42
PMCR- 2023/04/12
CRDT- 2023/02/23 17:23
PHST- 2023/04/25 06:42 [medline]
PHST- 2023/02/24 06:00 [pubmed]
PHST- 2023/02/23 17:23 [entrez]
PHST- 2023/04/12 00:00 [pmc-release]
AID - 00005176-202305000-00017 [pii]
AID - 10.1097/MPG.0000000000003745 [doi]
PST - ppublish
SO  - J Pediatr Gastroenterol Nutr. 2023 May 1;76(5):652-659. doi: 
      10.1097/MPG.0000000000003745. Epub 2023 Feb 22.