PMID- 33177798
OWN - NLM
STAT- MEDLINE
DCOM- 20210514
LR  - 20210514
IS  - 2219-2840 (Electronic)
IS  - 1007-9327 (Print)
IS  - 1007-9327 (Linking)
VI  - 26
IP  - 40
DP  - 2020 Oct 28
TI  - Pediatric bowel preparation: Sodium picosulfate, magnesium oxide, citric acid vs 
      polyethylene glycol, a randomized trial.
PG  - 6260-6269
LID - 10.3748/wjg.v26.i40.6260 [doi]
AB  - BACKGROUND: Bowel preparation in children can be challenging. AIM: To describe 
      the efficacy, safety, and tolerability of sodium picosulfate, magnesium oxide, 
      and citric acid (SPMC) bowel preparation in children. METHODS: Phase 3, 
      randomized, assessor-blinded, multicenter study of low-volume, divided dose SPMC 
      enrolled children 9-16 years undergoing elective colonoscopy. Participants 9-12 
      years were randomized 1:1:1 to SPMC (1/2) dose x 2, SPMC 1 dose x 2, or polyethylene 
      glycol (PEG). Participants 13-16 years were randomized 1:1 to SPMC 1 dose x 2 or 
      PEG. PEG-based bowel preparations were administered per local protocol. Primary 
      efficacy endpoint for quality of bowel preparation was responders (rating of 
      'excellent' or 'good') by modified Aronchick Scale. Secondary efficacy endpoint 
      was participant's tolerability and satisfaction from a 7-item questionnaire. 
      Safety assessments included adverse events (AEs) and laboratory evaluations. 
      RESULTS: 78 participants were randomized, 48 were 9-12 years, 30 were 13-16 
      years. For the primary efficacy endpoint in 9-12 years, 50.0%, 87.5%, and 81.3% 
      were responders for SPMC (1/2) dose x 2, SPMC 1 dose x 2, and PEG groups, 
      respectively. Responder rates for 13-16 years were 81.3% for SPMC 1 dose x 2 and 
      85.7% for PEG. Overall, 43.8% of participants receiving SPMC 1 dose x 2 reported 
      it was 'very easy' or 'easy' to drink, compared with 20.0% receiving PEG. 
      Treatment-emergent AEs were reported by 45.5% of participants receiving SPMC 1 
      dose x 2 and 63.0% receiving PEG. CONCLUSION: SPMC was an efficacious and safe 
      for bowel preparation in children 9-16 years, with comparable efficacy to PEG. 
      Tolerability for SPMC was higher compared to PEG.
CI  - (c)The Author(s) 2020. Published by Baishideng Publishing Group Inc. All rights 
      reserved.
FAU - Cuffari, Carmen
AU  - Cuffari C
AD  - Department of Pediatrics, The Johns Hopkins School of Medicine, Baltimore, MD 
      21287, United States. ccuffari@jhmi.edu.
FAU - Ciciora, Steven L
AU  - Ciciora SL
AD  - Department of Pediatrics, The Ohio State University College of Medicine, 
      Colombus, OH 43205, United States.
FAU - Ando, Masakazu
AU  - Ando M
AD  - Department of Statistics, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, 
      United States.
FAU - Boules, Mena
AU  - Boules M
AD  - Department of Medical Affairs, Ferring Pharmaceuticals Inc, Parsippany, NJ 07054, 
      United States.
FAU - Croffie, Joseph M
AU  - Croffie JM
AD  - Department of Pediatrics, Indiana University School of Medicine, Indianapolis, IN 
      46202, United States.
LA  - eng
PT  - Clinical Trial
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PL  - United States
TA  - World J Gastroenterol
JT  - World journal of gastroenterology
JID - 100883448
RN  - 0 (Cathartics)
RN  - 0 (Citrates)
RN  - 0 (Organometallic Compounds)
RN  - 0 (Picolines)
RN  - 2968PHW8QP (Citric Acid)
RN  - 3A3U0GI71G (Magnesium Oxide)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
RN  - LR57574HN8 (picosulfate sodium)
SB  - IM
MH  - Cathartics/adverse effects
MH  - Child
MH  - Citrates/adverse effects
MH  - Citric Acid/adverse effects
MH  - Colonoscopy
MH  - Humans
MH  - *Magnesium Oxide/adverse effects
MH  - *Organometallic Compounds/adverse effects
MH  - Picolines
MH  - Polyethylene Glycols/adverse effects
PMC - PMC7596638
OTO - NOTNLM
OT  - Children
OT  - Colon cleansing
OT  - Colonoscopy
OT  - Polyethylene glycol
OT  - Sodium picosulfate, magnesium oxide, and citric acid
COIS- Conflict-of-interest statement: Dr. Cuffari participated in the speaker's bureau 
      for Abbott Nutrition, Abbvie, and Prometheus Laboratories.
EDAT- 2020/11/13 06:00
MHDA- 2021/05/15 06:00
PMCR- 2020/10/28
CRDT- 2020/11/12 05:40
PHST- 2020/05/26 00:00 [received]
PHST- 2020/09/16 00:00 [revised]
PHST- 2020/09/25 00:00 [accepted]
PHST- 2020/11/12 05:40 [entrez]
PHST- 2020/11/13 06:00 [pubmed]
PHST- 2021/05/15 06:00 [medline]
PHST- 2020/10/28 00:00 [pmc-release]
AID - 10.3748/wjg.v26.i40.6260 [doi]
PST - ppublish
SO  - World J Gastroenterol. 2020 Oct 28;26(40):6260-6269. doi: 
      10.3748/wjg.v26.i40.6260.