Trial reportAlimentary pharmacology & therapeutics2011
Randomised clinical trial: The ileal bile acid transporter inhibitor A3309 vs. placebo in patients with chronic idiopathic constipation--a double-blind study.
Trial report in Alimentary pharmacology & therapeutics, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 50 papers, 1 of them a synthesis that pooled it.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
50 citing papers in PubMed, 1 synthesis or guideline pooled it, 112 citations in OpenAlex.
- Guideline
- Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.Advances in therapy · 2022Trial
- Efficacy of elobixibat as bowel preparation agent for colonoscopy: Prospective, randomized, multi-center study.Digestive endoscopy : official journal of the Japan Gastroenterological Endoscopy Society · 2022Trial
- 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
- Pilot study with IBAT inhibitor A4250 for the treatment of cholestatic pruritus in primary biliary cholangitis.Scientific reports · 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
- Pharmacological management of childhood constipation: Bridging today's gaps with tomorrow's therapies.World journal of clinical pediatrics · 2026Review
- 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
- An Update of Pharmacological Management in Children with Functional Constipation.Paediatric drugs · 2023Review
- The Pathological Effects of Circulating Hydrophobic Bile Acids in Alzheimer's Disease.Journal of Alzheimer's disease reports · 2023Review
- Impact of elobixibat on serum and fecal bile acid levels and constipation symptoms in patients with chronic constipation.Journal of gastroenterology and hepatology · 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
- Modulation of Bile Acid Metabolism to Improve Plasma Lipid and Lipoprotein Profiles.Journal of clinical medicine · 2021Review
- Role of gut microbiota in functional constipation.Gastroenterology report · 2021Review
- Article
- Potential of ileal bile acid transporter inhibition as a therapeutic target in Alagille syndrome and progressive familial intrahepatic cholestasis.Liver international : official journal of the International Association for the Study of the Liver · 2020Review
- The effect of exenatide on fasting bile acids in newly diagnosed type 2 diabetes mellitus patients, a pilot study.BMC pharmacology & toxicology · 2020Article
Corrections and comments
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundOne half of patients with constipation are not satisfied with available therapies, hence there is a need for more effective and well-tolerated drugs.
aimTo evaluate the effects of a specific inhibitor of the Ileal Bile Acid Transporter (IBAT; syn apical sodium-dependent bile acid transporter; ASBT) in patients with chronic idiopathic constipation (CIC) with focus on safety, colonic transit and efficacy signals.
methodsThis was a single-centre, prospective, randomised, double-blind, placebo-controlled study with a dose-escalating design in patients with CIC. In addition to evaluation of conventional safety and tolerability parameters, (i) colonic transit time (CTT) was measured using radio-opaque markers, (ii) metabolic parameters [lipid profile, C4 (7α-hydroxy-4-cholesten-3-one) and FGF19 (Fibroblast Growth Factor 19)] were evaluated, and (iii) constipation parameters, such as changes in stool frequency and consistency, were analysed.
resultsThirty patients were randomised into five dose-levels (range: 0.1-10 mg/day) or to placebo. All patients completed a 14-day treatment period, and the safety/tolerability analysis was favourable. A3309, present in picomolar concentrations in plasma, induced up to a three-fold increase in bile acid synthesis (C4) and a reduction of plasma FGF19, as well as reduction in total and LDL cholesterol. CTT was reduced in the highest dose groups; the main acceleration was identified in the left colon. Efficacy parameters showed trends for increased number of spontaneous bowel movements and improved stool consistency.
conclusionsIleal Bile Acid Transporter inhibition is a novel mechanism for treatment of patients with chronic idiopathic constipation and has additional benefits of improving metabolic parameters (EudraCT 2008-003255-72).
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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.