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<p>Functional constipation (FC) is a prevalent pediatric gastrointestinal disorder that affects quality of life. This study aimed to evaluate the safety, efficacy, and acceptability of PentaSure Fiber, containing digestion-resistant maltodextrin, for children aged 6 to 12 years. A prospective, open-label, single-arm, observational post-marketing surveillance study enrolled 200 children diagnosed with FC as per Rome IV criteria. Participants received PentaSure Fiber 10&#xa0;g/day orally for 10 consecutive days, followed by 7 days of safety follow-up. Stool frequency and consistency (Bristol Stool Form Scale), acceptability, and safety were assessed at baseline, during treatment, and post-supplementation. Stool frequency increased significantly from 0.29 ± 0.09 (normalized value) at base line to 1.21 ± 0.48 by Day 10 (<i>p</i> &lt; 0.001) with sustained improvement observed on Day 17 (1.31 ± 0.49; <i>p</i> = 0.019). Stool consistency improved markedly during supplementation. By Day 2, 97% of participants achieved ideal stool types (Bristol Stool Form Scale types 3 and 4), which increased to 98.5% by Day 10 (<i>p</i> &lt; 0.001). All participants achieved ideal stool consistency by Day 17. Treatment compliance was 100%, with acceptability increasing from 93% on Day 10 to 97% on Day 17. No adverse events or serious adverse events were reported. PentaSure Fiber was well tolerated and associated with improvements in stool frequency and consistency; however, controlled studies are required to confirm these findings.</p>

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An open-label study to evaluate safety, efficacy, and acceptability of PentaSure Fiber in the management of functional constipation in children

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月3日

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  • M. Sahana,
  • Nikhil Arun Kelkar

摘要

Functional constipation (FC) is a prevalent pediatric gastrointestinal disorder that affects quality of life. This study aimed to evaluate the safety, efficacy, and acceptability of PentaSure Fiber, containing digestion-resistant maltodextrin, for children aged 6 to 12 years. A prospective, open-label, single-arm, observational post-marketing surveillance study enrolled 200 children diagnosed with FC as per Rome IV criteria. Participants received PentaSure Fiber 10 g/day orally for 10 consecutive days, followed by 7 days of safety follow-up. Stool frequency and consistency (Bristol Stool Form Scale), acceptability, and safety were assessed at baseline, during treatment, and post-supplementation. Stool frequency increased significantly from 0.29 ± 0.09 (normalized value) at base line to 1.21 ± 0.48 by Day 10 (p < 0.001) with sustained improvement observed on Day 17 (1.31 ± 0.49; p = 0.019). Stool consistency improved markedly during supplementation. By Day 2, 97% of participants achieved ideal stool types (Bristol Stool Form Scale types 3 and 4), which increased to 98.5% by Day 10 (p < 0.001). All participants achieved ideal stool consistency by Day 17. Treatment compliance was 100%, with acceptability increasing from 93% on Day 10 to 97% on Day 17. No adverse events or serious adverse events were reported. PentaSure Fiber was well tolerated and associated with improvements in stool frequency and consistency; however, controlled studies are required to confirm these findings.