Trial reportThe American journal of gastroenterology2011
A randomized placebo-controlled phase IIb trial of a3309, a bile acid transporter inhibitor, for chronic idiopathic constipation.
Trial report in The American journal of gastroenterology, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 2 registered trials, which are not on this map. Cited by 75 papers, 3 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.
A Phase IIb, Double-blind, Randomised, Placebo-controlled, Multi-centre, Dose-finding Efficacy and Safety Study of a Range of Doses of Elobixibat in Patients With Chronic Idiopathic Constipation
Fecal Bile Acids, Fecal Short Chain Fatty Acids and the Intestinal Microbiota in Patients With Irritable Bowel Syndrome (IBS) and Control Volunteers: Diet Challenge
Who cites it
75 citing papers in PubMed, 3 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- 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
- Pharmacological treatment for antipsychotic-related constipation.The Cochrane database of systematic reviews · 2017Pooled it
- Magnesium-Rich Mineral Water Improves Stool Consistency and Bowel Habits in Healthy Subjects: A Randomized Controlled Trial.Neurogastroenterology and motility · 2026Trial
- Effect of single and multiple doses of elobixibat, an ileal bile acid transporter inhibitor, on chronic constipation: A randomized controlled trial.British journal of clinical pharmacology · 2018Trial
- Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial.Journal of gastroenterology · 2018Trial
- Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial.BMC gastroenterology · 2018Trial
- Specific inhibition of bile acid transport alters plasma lipids and GLP-1.BMC cardiovascular disorders · 2015Trial
- HSD3B1 links ileal steroid metabolism to bile acid regulation in patients with prostate cancer.The Journal of clinical investigation · 2026Article
- Ileal bile acid transporter inhibitors for chronic constipation in the elderly.World journal of gastrointestinal pharmacology and therapeutics · 2026Article
- Inhibition of bile acid reabsorption as a treatment for constipation.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2025Article
- Efficacy and safety of elobixibat in combination with or switched from conventional treatments of chronic constipation: A retrospective observational study.JGH open : an open access journal of gastroenterology and hepatology · 2024Article
- Imaging Classification of Constipation.Journal of the anus, rectum and colon · 2023Article
- Safety and Efficacy of Elobixibat, an Ileal Bile Acid Transporter Inhibitor, in Elderly Patients With Chronic Idiopathic Constipation According to Administration Time: Interim Analysis of Post-marketing Surveillance.Journal of neurogastroenterology and motility · 2022Article
- Ileal Bile Acid Transporter Inhibition Reduces Post-Transplant Diarrhea and Growth Failure in FIC1 Disease-A Case Report.Children (Basel, Switzerland) · 2022Article
- Contributions of bile acids to gastrointestinal physiology as receptor agonists and modifiers of ion channels.American journal of physiology. Gastrointestinal and liver physiology · 2022Article
- Current Treatment Options and Therapeutic Insights for Gastrointestinal Dysmotility and Functional Gastrointestinal Disorders.Frontiers in pharmacology · 2022Review
- Role of gut microbiota in functional constipation.Gastroenterology report · 2021Review
- Review article: diagnosis, management and patient perspectives of the spectrum of constipation disorders.Alimentary pharmacology & therapeutics · 2021Review
- Targeting the Four Pillars of Enterohepatic Bile Salt Cycling; Lessons From Genetics and Pharmacology.Hepatology (Baltimore, Md.) · 2021Review
15 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
- Commented on by
- Commented on by
- Erratum issued
Authors and funding
5 authors at 4 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectivesA3309 is a minimally absorbed ileal bile acid (BA) transporter (IBAT) inhibitor. We conducted an 8-week, multicenter, randomized, double-blind, placebo-controlled, parallel group, phase IIb study, which evaluated A3309 in patients with chronic idiopathic constipation (CIC).
methodsPatients with CIC (modified Rome III criteria and <3 complete (CSBM) spontaneous bowel movements (SBMs)/week during the 2-week baseline) were randomized to 5, 10, or 15 mg A3309 or placebo once daily. The primary end point was change in SBM number during week 1 compared with baseline. Other bowel and abdominal symptoms were assessed as secondary end points. Serum 7αC4 and lipids were evaluated as biomarkers of BA synthesis/loss.
resultsIn all, 190 patients (mean 48 years, 90% female) were randomized. Mean increase (95% confidence interval) in SBM for week 1 were 1.7 (0.7-2.8) for placebo vs. 2.5 (1.5-3.5), 4.0 (2.9-5.0), and 5.4 (4.4-6.4) for 5 mg, 10 mg (P<0.002), and 15 mg (P<0.001) A3309, respectively. Increased stool frequency was maintained over 8 weeks. Time to first SBM and CSBM were significantly reduced in the 10- and 15-mg A3309 groups compared with placebo. Straining and bloating decreased with A3309 compared with placebo (P<0.05). Increased 7αC4 and reduced low-density lipoprotein cholesterol with A3309 suggested increased BA synthesis and BA loss. The most common adverse events (AEs) were abdominal pain and diarrhea, which occurred most commonly in the 15-mg A3309 group. No drug-related serious AEs were observed.
conclusionsA3309 increased stool frequency and improved constipation-related symptoms in CIC; effects were maintained over 8 weeks of treatment.
Indexed as
Identifiers
What OpenQuestion holds
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.