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Observational Study
. 2023 Aug 25;102(34):e34899.
doi: 10.1097/MD.0000000000034899.

Efficacy and safety of human gut-derived multi-strain probiotics in patients with irritable bowel syndrome: A prospective open-label observation study

Chang Kyo Oh  1 , Jae Keun Park, Yu Jin Kim, Jin Bae Kim
Affiliations
Observational Study

Efficacy and safety of human gut-derived multi-strain probiotics in patients with irritable bowel syndrome: A prospective open-label observation study

Chang Kyo Oh et al. Medicine (Baltimore). .

Abstract

This study aimed to investigate the efficacy and safety of human gut-derived multi-strain probiotics in patients with irritable bowel syndrome (IBS). This was an open-label, prospective, observational study. Patients with IBS were administered human gut-derived multi-strain probiotics for 4 weeks. The primary and secondary outcomes were based on the overall responder rate of the total IBS severity scoring system (IBS-SSS) score (>50-point decrease) and the IBS quality of life (IBS-QOL) score and IBS-SSS1 subscore (>10-point decrease in both scores), respectively. The estimated response rate is 55%. Of 44 patients, the total IBS-SSS score responder rate was 18.2% and 63.6% of patients at 2 and 4 weeks, respectively (P = .018). Compared with baseline, a significant improvement in the IBS-QOL score was observed in 27.3% and 63.6% of patients at 2 and 4 weeks, respectively (P = .001). Overall improvement rates in the IBS-SSS1 subscore were observed in 29.5% and 61.4% of patients at 2 and 4 weeks, respectively (P < .001). Primary and secondary outcomes were higher at 4 weeks (total IBS-SSS score, 63.6%; IBS-QOL score, 63.6%; IBS-SSS1 subscore, 61.4%) than the estimated responder rate (55%). Human gut-derived multi-strain probiotics have the potential to become an effective and safe treatment option for IBS patients.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1.
Figure 1.
The percentage of patients reported as responder for primary and secondary outcomes: (A) total IBS-SSS score; (B) IBS-SSS1 score (abdominal pain severity); (C) IBS-QOL score. IBS = irritable bowel syndrome, QOL = quality of life, SSS = severity scoring system.
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