Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trialReport as inadecuate




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Trials

, 12:219

First Online: 06 October 2011Received: 12 August 2011Accepted: 06 October 2011DOI: 10.1186-1745-6215-12-219

Cite this article as: Ko, SJ., Ryu, B., Kim, J. et al. Trials 2011 12: 219. doi:10.1186-1745-6215-12-219

Abstract

BackgroundIrritable bowel syndrome IBS is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habits without organic disease. Many patients seek alternative IBS treatments because of the limitations of conventional treatments. Gwakhyangjeonggisan GJS, a herbal formula, has long been used for alleviating diarrhea-predominant IBS D-IBS in traditional medicine. Duolac7S, which comprises 7 bacterial species as probiotics, has been frequently used for D-IBS. Although GJS and Duolac7S have been administered simultaneously in many D-IBS patients, no study has investigated the effects of GJS and Duolac7S combination therapy on D-IBS.

Methods-DesignThe current trial is a randomized, double-blinded, placebo-controlled, 4-arm study. After a 2-week run-in period, 60 patients with D-IBS will be randomly assigned to one of the 4 combination groups consisting of GJS water extract granules, 3 g-pack, 3 times a day with Duolac7S powder form, 1 capsule, 2 times a day or their placebos and followed up for 2 weeks. The assigned treatments will last for 8 weeks. The primary outcomes are adequate relief of IBS pain and discomfort and the proportion of responders on a weekly basis. The secondary outcomes are visual analog scale for IBS symptoms on a daily basis, quality of life at 0, 8, and 10 weeks, intestinal permeability, and composition of intestinal microbiota at 0 and 8 weeks.

DiscussionThe present study is designed to examine the safety and efficacy of GJS and Duolac7S combination therapy on D-IBS. Our study provides the clinical evidence of a new therapeutic strategy for D-IBS.

Trial registrationClinicalTrials.gov NCT01342718.

AbbreviationsANOVAanalysis of variance

ARadequate relief

CBCcomplete blood count

CROclinical research organization

CRPC-reactive protein

DGGEdenaturing gradient gel electrophoresis

D-IBSdiarrhea-predominant irritable bowel syndrome

DUODuolac7S

DUO-Pplacebo of Duolac7S

GJGGwakjungsan granule

GJSGwakhyangjeonggisan

GJS-Pplacebo of Gwakhyangjeonggisan

IBSirritable bowel syndrome

IBS-QoLa quality of life measurement for persons with irritable bowel syndrome

IRBsinstitutional review boards

RT-PCRreal-time polymerase chain reaction

VASvisual analog scale.

Electronic supplementary materialThe online version of this article doi:10.1186-1745-6215-12-219 contains supplementary material, which is available to authorized users.

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Author: Seok-Jae Ko - Bongha Ryu - Jinsung Kim - Beom-Gi Hong - Inkwon Yeo - Beom-Joon Lee - Jin-Moo Lee - Jae-Woo Park

Source: https://link.springer.com/







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