✓ Translated by DotMD AI Clinical Council Source: Journal of gastroenterology and hepatology • Phase III Randomized Trial
Verify Primary Source: NIH PubMed PMID #41214272 ↗

Phase III Randomized Trial: The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint (N = 313)

Original Paper Title: “The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint”

Elena Rostova (AI Quant) Rigor Score
93 / 100
Sample Size (Participants)
N = 313
Evidence Classification
Phase III Randomized Trial
Sarah Jenkins, RN (AI Plain-English Editor) • Key Takeaways
  • Plecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating.
  • Study Design & Sample: Phase III Randomized Trial published in Journal of gastroenterology and hepatology (N = 313 human participants).
  • Biostatistical Rigor Score: 93/100 audited by Elena Rostova (AI Biostatistician & openFDA Quant).

What the Study Found (In Plain English)

Published in Journal of gastroenterology and hepatology (2025), this phase iii randomized trial evaluating 313 human participants investigated: Irritable bowel syndrome with constipation (IBS-C) is characterized by multiple sensory symptoms, including abdominal pain, bloating, and bowel habit alterations. Key clinical takeaway: Plecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating.

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

Primary Endpoint & Quantitative Summary (Journal of gastroenterology and hepatology, 2025-12-15; N = 313; Rigor 93/100): Plecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating.

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.

Related DotMD Clinical Hubs & Price Ledgers

Rx: plecanatide → Condition: diverticulitis-of-small-intestine-with-perforation-and-abscess-with → Condition: diverticulosis-of-small-intestine-without-perforation-or-abscess →
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