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. 2019 Jan;40(1):2-8.
doi: 10.4082/kjfm.17.0064. Epub 2018 Oct 26.

A Randomized Clinical Trial of Synbiotics in Irritable Bowel Syndrome: Dose-Dependent Effects on Gastrointestinal Symptoms and Fatigue

Sang-Hoon Lee  1 , Doo-Yeoun Cho  2 , Seok-Hoon Lee  1 , Kyung-Sun Han  1 , Sung-Won Yang  1 , Jin-Ho Kim  1 , Su-Hyun Lee  1 , Soo-Min Kim  1 , Kyu-Nam Kim  1
Affiliations

A Randomized Clinical Trial of Synbiotics in Irritable Bowel Syndrome: Dose-Dependent Effects on Gastrointestinal Symptoms and Fatigue

Sang-Hoon Lee et al. Korean J Fam Med. 2019 Jan.

Abstract

Background: This double-blind, randomized controlled design study aimed to assess the dose-dependent effects of synbiotics on gastrointestinal symptoms of and fatigue in irritable bowel syndrome (IBS).

Methods: Thirty subjects with IBS were randomly assigned into the following three groups and received 2 capsules a day for 8 weeks: (1) high-dose (2 capsules of synbiotics); (2) low-dose (1 capsule of synbiotics and 1 capsule of placebo); and (3) placebo (2 capsules of placebo). At baseline and 8 weeks, they completed the study questionnaires.

Results: Two subjects in the high-dose group were lost to follow-up, leaving a total of 28 patients for the analysis. After 8 weeks, abdominal discomfort, abdominal bloating, frequency of formed stool, fatigue Visual Analog Scale (VAS), and Multidimensional Fatigue Inventory were significantly different among the groups (P=0.002, 0.006, 0.007, 0.028, and 0.041, respectively, by Kruskal-Wallis test). However, only abdominal discomfort, abdominal bloating, frequency of formed stool, and fatigue VAS were significantly improved in the high-dose group compared with those in the placebo group (P=0.002, 0.003, 0.002, and 0.013, respectively) by Mann-Whitney test with Bonferroni correction. No adverse drug reactions were reported.

Conclusion: High-dose synbiotics were superior to placebo in improving bowel symptoms and fatigue of IBS patients, suggesting that synbiotic dosage plays an important role in the treatment of IBS.

Keywords: Dose-Response Relationship; Fatigue; Irritable Bowel Syndrome; Probiotics; Synbiotics.

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Conflict of interest statement

No potential conflict of interest relevant to this article was reported.

Figures

Figure. 1.
Figure. 1.
Study flow diagram. GI, gastrointestinal.
See this image and copyright information in PMC

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