Trial reportPloS one2015
Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.
Trial report in PloS one, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642914 (Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline), which is not on this map. Cited by 39 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase 3b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Chronic Constipation and Prominent Abdominal Bloating at Baseline
Who cites it
39 citing papers in PubMed, 5 syntheses or guidelines pooled it, 80 citations in OpenAlex.
- [Seoul Consensus on Clinical Practice Guidelines for Functional Constipation].The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2025Guideline
- Guideline
- Comparative profiles of lubiprostone, linaclotide, and elobixibat for chronic constipation: a systematic literature review with meta-analysis and number needed to treat/harm.BMC gastroenterology · 2024Pooled it
- Impact of Clinical Outcome Measures on Placebo Response Rates in Clinical Trials for Chronic Constipation: A Systematic Review and Meta-analysis.Clinical and translational gastroenterology · 2020Pooled it
- Efficacy and Tolerability of Guanylate Cyclase-C Agonists for Irritable Bowel Syndrome with Constipation and Chronic Idiopathic Constipation: A Systematic Review and Meta-Analysis.The American journal of gastroenterology · 2018Pooled it
- Effect of Age and Age-Defined Menopausal Status on Linaclotide Efficacy and Safety in Adults With Irritable Bowel Syndrome With Constipation or Chronic Idiopathic Constipation: Post Hoc Analyses of Phase 2b/3 Studies.Neurogastroenterology and motility · 2026Trial
- Evaluation of the efficacy of polyethylene glycol in combination with different doses of linaclotide in a fractionated bowel preparation for colonoscopy: a prospective randomized controlled study.International journal of colorectal disease · 2024Trial
- Polyethylene Glycol 3350 in the Treatment of Chronic Idiopathic Constipation: Post hoc Analysis Using FDA Endpoints.Canadian journal of gastroenterology & hepatology · 2022Trial
- Lessons learned: Chronic idiopathic constipation patient experiences with over-the-counter medications.PloS one · 2021Trial
- Trial
- Electroacupuncture for Women with Chronic Severe Functional Constipation: Subgroup Analysis of a Randomized Controlled Trial.BioMed research international · 2019Trial
- Low-Dose Linaclotide (72 μg) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.The American journal of gastroenterology · 2018Trial
- Constipation with bloating: a clinical approach to evaluation and management.Annals of medicine · 2026Review
- Diagnosis and treatment of slow-transit constipation.BMC gastroenterology · 2026Review
- Treatment Patterns, Perceptions, Barriers, and Costs in Patients With Chronic Idiopathic Constipation in the United States.Gastro hep advances · 2026Article
- Irritable Bowel Syndrome in Inflammatory Bowel Disease: An Evidence-Based Practical Review.Journal of clinical medicine · 2025Review
- A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.Journal of managed care & specialty pharmacy · 2024Observational
- Pharmacologic Treatment of Chronic Constipation.The Korean journal of gastroenterology = Taehan Sohwagi Hakhoe chi · 2024Review
- Relationship Between Colonic Transit Response to Eating With Self-reported Constipation Severity in Constipated Patients According to the Phenotype.Journal of neurogastroenterology and motility · 2024Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
13 authors at 5 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAbdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating.
methodsThis Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period. Patients reported abdominal symptoms (including bloating) and bowel symptoms daily; adverse events were monitored. The primary responder endpoint required patients to have ≥3 complete spontaneous bowel movements/week with an increase of ≥1 from baseline, for ≥9 of 12 weeks. The primary endpoint compared linaclotide 145 μg vs. placebo.
resultsThe intent-to-treat population included 483 patients (mean age=47.3 years, female=91.5%, white=67.7%). The primary endpoint was met by 15.7% of linaclotide 145 μg patients vs. 7.6% of placebo patients (P<0.05). Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity). Approximately one-third of linaclotide patients (each group) had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01). Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients. AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.
conclusionsOnce-daily linaclotide (145 and 290 μg) significantly improved bowel and abdominal symptoms in chronic idiopathic constipation patients with moderate-to-severe baseline abdominal bloating; in particular, linaclotide significantly improved abdominal bloating compared to placebo, an important finding given the lack of agents available to treat abdominal bloating in chronic idiopathic constipation patients.
trial registrationClinicalTrials.gov NCT01642914.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.