title: Effect of herbal extract granules combined with probiotic mixture on irritable bowel syndrome with diarrhea: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Irritable 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
  The 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).
  
  
  CONCLUSIONS
  The 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.
authors: Department of Internal Medicine, College of Oriental Medicine, Kyung Hee University, Seoul, Republic of Korea.
authors: Seok-Jae
authors: SJ
authors: Ko
authors: Bongha
authors: B
authors: Ryu
authors: Jinsung
authors: J
authors: Kim
authors: Beom-Gi
authors: BG
authors: Hong
authors: Inkwon
authors: I
authors: Yeo
authors: Beom-Joon
authors: BJ
authors: Lee
authors: Jin-Moo
authors: JM
authors: Lee
authors: Jae-Woo
authors: JW
authors: Park
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D002985:Clinical Protocols; D003967:Diarrhea / Q000188:drug therapy*; D004311:Double-Blind Method; D006801:Humans; D007413:Intestinal Mucosa / Q000378:metabolism; D007422:Intestines / Q000382:microbiology; D043183:Irritable Bowel Syndrome / Q000188:drug therapy*; D008875:Middle Aged; D017063:Outcome Assessment, Health Care; D010539:Permeability; D010936:Plant Extracts / Q000008:administration & dosage*; D019936:Probiotics / Q000008:administration & dosage*
chemical_list: D010936:Plant Extracts