Dataset Information

Urgency as an Endpoint in Irritable Bowel Syndrome.

ABSTRACT: BACKGROUND:The choice of endpoints is crucial for proper evaluation of agents in clinical trials of irritable bowel syndrome (IBS). In a recently published draft guidance for IBS from the United States Food and Drug Administration (FDA), urgency was not considered an appropriate primary endpoint. The FDA's position is that it is not clear how patients with diarrhea-predominant IBS (D-IBS) "define or describe urgency". The aims of this study were to evaluate the association of urgency with stool frequency and consistency in patients with D-IBS and to describe results from patient interviews on their understanding of the term urgency. METHODS:A retrospective analysis of clinical trial data in patients with D-IBS was conducted. Analyses focused on the relationship of urgency to stool frequency and consistency. Interviews were conducted with patients with D-IBS to test their understanding of the term urgency. RESULTS:On the days that patients reported urgency, as compared to the days that patients did not report urgency, they had more frequent bowel movements (3.9 versus 1.8) and looser stools (Bristol Stool Score: 5.4 versus 4.2). The differences for both parameters, evaluated on the days with or without urgency, were statistically significant. In patient interviews, patients with D-IBS had a clear understanding of the concept and terminology of urgency and considered it one of their two most bothersome symptoms. CONCLUSIONS:Urgency should be considered a suitable co-primary endpoint in D-IBS studies.

SUBMITTER: Mangel AW

PROVIDER: S-EPMC5139794 | biostudies-literature | 2011 Feb

REPOSITORIES: biostudies-literature

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Urgency as an Endpoint in Irritable Bowel Syndrome.

Mangel Allen W AW Wang Jianmin J Sherrill Beth B Gnanasakthy Ari A Ervin Claire C Fehnel Sheri E SE

Gastroenterology research 20110120 1

<h4>Background</h4>The choice of endpoints is crucial for proper evaluation of agents in clinical trials of irritable bowel syndrome (IBS). In a recently published draft guidance for IBS from the United States Food and Drug Administration (FDA), urgency was not considered an appropriate primary endpoint. The FDA's position is that it is not clear how patients with diarrhea-predominant IBS (D-IBS) "define or describe urgency". The aims of this study were to evaluate the association of urgency wit ...[more]

PMID: 27957006

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Project description:BackgroundThe intestinal microbiota is thought to be involved in the occurrence of inflammatory bowel disease in remission with irritable bowel syndrome (IBS)-type symptoms, but the specific distinct profile of these bacteria remains unclear. This cross-sectional study aims to investigate the fecal microbiota profiling in patients with these diseases.MethodsFecal samples from 97 subjects, including Crohn's disease patients in remission with IBS-type symptoms (CDR-IBS+) or without IBS-type symptoms (CDR-IBS-), ulcerative colitis patients in remission with IBS-type symptoms (UCR-IBS+) or without IBS-type symptoms (UCR-IBS-), IBS patients and healthy controls, were collected and applied 16S ribosomal DNA (rDNA) gene sequencing. The V4 hypervariable regions of 16S rDNA gene were amplified and sequenced by the Illumina MiSeq platform. The differences in the sample diversity index in groups were analyzed with R software.ResultsThe richness of the intestinal microbiota in the CDR-IBS group was markedly lower than those in the control and IBS groups based on the analysis of observed species and the Chao index (P < 0.05). The observed species index in the CDR-IBS+ group was higher than that in the CDR-IBS- group (median index: 254.8 vs 203, P = 0.036). No difference was found in alpha diversity between UCR patients with IBS-type symptoms and those without related symptoms. At the genus level, the number of Faecalibacterium in CDR patients with IBS-type symptoms increased significantly, while Fusobacterium decreased versus those without such symptoms (mean relative abundance of Faecalibacterium: 20.35% vs 5.18%, P < 0.05; Fusobacterium: 1.51% vs 5.2%, P < 0.05). However, compared with the UCR-IBS- group, the number of Faecalibacterium in the UCR-IBS+ group decreased, while the number of Streptococcus increased, but there was no significant difference in the genus structure. The abundance and composition of the microbiota of IBS patients were not distinct from those of healthy controls.ConclusionsThe IBS-type symptoms in CD patients in remission may be related to an increase in Faecalibacterium and a decrease in Fusobacterium. The IBS-type symptoms in UC patients in remission cannot be explained by changes in the abundance and structure of the intestinal microbiota.

Dataset Information

Urgency as an Endpoint in Irritable Bowel Syndrome.

Publications

Urgency as an Endpoint in Irritable Bowel Syndrome.

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