Evidence map›Paper›PMID 20691689›Full record

Trial reportGastroenterology2010

Chenodeoxycholate in females with irritable bowel syndrome-constipation: a pharmacodynamic and pharmacogenetic analysis.

Archana S Rao, Banny S Wong, Michael Camilleri, Suwebatu T Odunsi-Shiyanbade, Sanna McKinzie, Michael Ryks, Duane Burton, Paula Carlson, Jesse Lamsam, Ravinder Singh and 1 more

Registry-linked trialOpen access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Gastroenterology, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00912301 (Effect of Chenodeoxycholic Acid on Gastrointestinal Transit and Colonic Functions in Health and Constipation-predominant Irritable Bowel Syndrome), which is not on this map. Cited by 95 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
95citing papers in PubMed, 1 pooled it
8.6field-weighted citation impact, top 2% of its field
1 · What the graph read from 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.

2 · The registry

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.

NCT00912301 phase2completednot on this map

Effect of Chenodeoxycholic Acid on Gastrointestinal Transit and Colonic Functions in Health and Constipation-predominant Irritable Bowel Syndrome (IBS-C)

TypeinterventionalSponsorMayo ClinicRan2009 to 2009Enrolled36ConditionsConstipation-predominant Irritable Bowel SyndromeArmsSodium chenodeoxycholate (NaCDC), Placebo
3 · Its place in the literature

Who cites it

95 citing papers in PubMed, 1 synthesis or guideline pooled it, 183 citations in OpenAlex.

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35 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 1 institution in 1 country.

Archana S RaoClinical Enteric Neuroscience Translational and Epidemiological Research, Division of Biomedical Statistics and Informatics, College of Medicine, Mayo Clinic, Rochester, Minnesota, USA.
Banny S Wong
Michael Camilleri
Suwebatu T Odunsi-Shiyanbade
Sanna McKinzie
Michael Ryks
Duane Burton
Paula Carlson
Jesse Lamsam
Ravinder Singh
Alan R Zinsmeister
Mayo Clinic · US

Funding

MAYO CLINIC CENTER FOR TRANSLATIONAL SCIENCE ACTIVITIESUL1RR024150 · NCRR · MAYO CLINIC ROCHESTER · PI RIZZA, ROBERT A. · 2006 to 2011
$66.4M
Bile Acids, Genetic Control and Colonic Function in Irritable Bowel SyndromeR01DK092179 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2011 to 2015
$1.8M
ALPHA 2 ADRENERGIC CONTROL OF COLONIC FUNCTION IN IBSR01DK054681 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L · 1999 to 2007
$1.5M
Irritable bowel syndrome-diarrhea: the role of gluten intolerance and HLA-DQ2RC1DK086182 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2009 to 2010
$1.0M
Cannabinoid Mechanisms in Human Gastrointestinal Motor and Sensory FunctionsR01DK079866 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2009 to 2010
$752k
NCRR NIH HHS RR0024150NCRR NIH HHS UL1 RR024150NIDDK NIH HHS DK-079866NIDDK NIH HHS DK-086182NIDDK NIH HHS DK-54681NIDDK NIH HHS R01 DK054681NIDDK NIH HHS R01 DK079866NIDDK NIH HHS R01 DK092179NIDDK NIH HHS RC1 DK086182
6 · The paper itself

Abstract

BACKGROUND &

aimsSodium chenodeoxycholate (CDC) accelerates colonic transit in health. Our aim was to examine pharmacodynamics (colonic transit, bowel function) and pharmacogenetics of CDC in constipation-predominant irritable bowel syndrome (IBS-C).

methodsIn a double-blind placebo-controlled study, 36 female patients with IBS-C were randomized to treatment with delayed-release oral formulations of placebo, 500 mg CDC, or 1000 mg CDC for 4 days. We assessed gastrointestinal and colonic transit, stool characteristics, and associations of transit with fasting serum 7αC4 (surrogate of bile acid synthesis) and FGF19 (negative regulator of bile acid synthesis) levels. Candidate genetic polymorphisms involved in regulation of bile acid synthesis were analyzed in the 36 patients with IBS-C and 57 healthy volunteers to assess genetic influence on effects of CDC on transit.

resultsOverall colonic transit and ascending colon emptying (AC t(½)) were significantly accelerated in the CDC group compared with placebo (P = .005 and P = .028, respectively). Looser stool consistency (P = .003), increased stool frequency (P = .018), and greater ease of passage (P = .024) were noted with CDC compared with placebo. The most common side effect was lower abdominal cramping/pain (P = .01). Fasting serum 7αC4 (but not FGF19) was positively associated with colonic transit (r(s) = 0.749, P = .003, placebo group). Genetic variation in FGFR4 was associated with AC t(½) in response to CDC (uncorrected P = .015); αKlothoβ variant showed a gene-by-treatment interaction based on patient subgroup (uncorrected P = .0088).

conclusionsCDC accelerates colonic transit and improves bowel function in female patients with IBS-C. The rate of bile acid synthesis influences colonic transit. Genetic variation in negative feedback inhibition of bile acid synthesis may affect CDC-mediated acceleration of colonic transit.

Indexed as

Administration, OralAdultBile Acids and SaltsChenodeoxycholic AcidCholestenonesChromatography, High Pressure LiquidDelayed-Action PreparationsDNADose-Response Relationship, DrugDouble-Blind MethodEnzyme-Linked Immunosorbent AssayFemaleFibroblast Growth FactorsFollow-Up StudiesGastrointestinal AgentsGastrointestinal Transit7 alpha-hydroxy-4-cholesten-3-oneBile Acids and SaltsChenodeoxycholic AcidCholestenonesDelayed-Action PreparationsDNAFGF19 protein, humanFGFR4 protein, humanFibroblast Growth FactorsGastrointestinal AgentsReceptor, Fibroblast Growth Factor, Type 4

Identifiers

PMID20691689
PMCPMC3189402
OpenAlexW1988364155

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

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.