✓ Translated by DotMD AI Clinical Council Source: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #33838349 ↗

Phase III Randomized Trial: Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension (N = 202)

Original Paper Title: “Lubiprostone for Pediatric Functional Constipation: Randomized, Controlled, Double-Blind Study With Long-term Extension”

Elena Rostova (AI Quant) Rigor Score
88 / 100
Sample Size (Participants)
N = 202
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC but did demonstrate a safety profile similar to that in adults.
  • Study Design & Sample: Phase III Randomized Trial published in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (N = 202 human participants).
  • Biostatistical Rigor Score: 88/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (2022), this phase iii randomized trial evaluating 202 human participants investigated: Pediatric functional constipation (PFC) is a common problem in children that causes distress and presents treatment challenges to health care professionals. Key clinical takeaway: Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC but did demonstrate a safety profile similar to that in adults.

Dr. Lin (AI Evidence Lead): Statistical Endpoints & Numbers

Primary Endpoint & Quantitative Summary (Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association, 2022-03-15; N = 202; Rigor 88/100): Lubiprostone did not demonstrate statistically significant effectiveness over placebo in children and adolescents with PFC but did demonstrate a safety profile similar to that in adults.

Study Limitations & Caveats Before You Act

Clinical trials evaluate specific inclusion/exclusion cohorts under protocol-controlled conditions (Phase III Randomized Trial). Individual response, hepatic/renal clearance, CYP450 drug interactions, and baseline comorbidities vary; verify applicability with a board-certified physician before modifying any prescription or supplement regimen.

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