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Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial

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Abstract

Anti-tuberculosis (TB) drugs can induce a series of gastrointestinal adverse events, which can seriously affect patients’ quality of life and may lead to treatment failure. Studies have shown that probiotics treatments can improve antibiotic-induced gastrointestinal symptoms. In this randomized, open-label, dose–response clinical trial, we investigated the preventive effects of Lactobacillus casei on anti-TB-induced gastrointestinal adverse events. In total, 429 adult patients who underwent intensive-phase anti-TB therapy were included and randomly assigned to consume one bottle of L. casei of per day (low-dose group, n = 142), two bottles of L. casei per day (high-dose group, n = 143), or no intervention (control group, n = 144) for 2 months. Each bottle of L. casei contained 10 billion colony-forming units of live L. casei. Patients’ daily gastrointestinal symptoms were recorded during the intervention period. After 2 months of L. casei consumption, 397 patients had completed the intervention. Both the high and low dose L. casei groups (37.6% and 29.4%, respectively) had lower incidences of anti-TB-associated total gastrointestinal adverse events than the control group (50.0%). The high and low dose L. casei groups (3.5 d and 5.8 d, respectively) also had shorter duration anti-TB-associated adverse gastrointestinal symptoms than the control group (6.2 d). Regarding individual symptoms, the higher L. casei dose resulted in a lower incidence of vomiting and appetite loss. Similar dose-dependent protective effects of L. casei were observed regarding the duration of vomiting and appetite loss. These findings indicated that daily L. casei consumption prevented anti-TB-associated gastrointestinal adverse events. This trial was registered at the Chinese Clinical Trial Register (ChiCTR-IOR-17013210).

Graphical abstract: Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial

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Publication details

The article was received on 19 Jul 2019, accepted on 17 Nov 2019 and first published on 19 Nov 2019


Article type: Paper
DOI: 10.1039/C9FO01583C
Food Funct., 2020, Advance Article

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    Efficacy of proprietary Lactobacillus casei for anti-tuberculosis associated gastrointestinal adverse reactions in adult patients: a randomized, open-label, dose–response trial

    S. Lin, S. Zhao, J. Liu, J. Zhang, C. Zhang, H. Hao, Y. Sun, J. Cai, Y. Yang, Y. Ma, Y. Li, J. Wang and A. Ma, Food Funct., 2020, Advance Article , DOI: 10.1039/C9FO01583C

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