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Bifidobacterium lactis CCT 7858 Improves Gastrointestinal Symptoms by Antibiotics Treatment: a Double-Blind, Randomized, Placebo-Controlled Trial

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Abstract

Diarrhea is one of the most frequent side effects of antibiotic treatment and occurs in 25 to 40% of patients in use. One potential strategy to prevent this side effect is the concurrent use of probiotics. This study evaluated the efficacy of the strain Bifidobacterium lactis CCT 7858 in the prevention of diarrhea and improvement of gastrointestinal symptoms in hospitalized patients using antibiotics. This was a randomized, blinded, placebo-controlled clinical trial. This study included 104 patients in antibiotic treatment. Patients were randomized into two groups: placebo (maltodextrin) and intervention (strain Bifidobacterium lactis CCT 7858 at 9 × 1010 CFU concentration; GABBIA® Biotecnology, Santa Catarina, Brazil). Patients were supplemented depending on the duration of antibiotic therapy, and both were evaluated with scales in two moments: before and after treatment. We included 104 hospitalized patients. In follow-up, 38 (74.5%) of the B. lactis group have no reported diarrhea. In secondary outcomes, in five day strong abdominal distension was reported in 4 (7,3) placebo group and not reported in B. lactis. Abdominal noises, nausea, and vomiting were not registered in any group. B. lactis strain has been considered safe and with several benefits, including reduction of soft stools and gastrointestinal symptoms how abdominal noise, pain and distension, as well reduction of diarrhea.

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Funding

This study was funded by the Gabbia Biotechnology.

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Authors and Affiliations

Authors

Contributions

MM, GFAJ: conceptualization and design of the study; data curation; formal analysis and methodology; roles/writing-original draft. EC, LC, CSS: conceptualization, data curation, methodology. APLV, MPR, FR: conceptualization and design of the study; methodology. CM, KM: statistical analyses; writing-review and editing. APV, MR, FR: design of the study, funding acquisition. DCD and FDP: conceptualization and design of the study; project administration; supervision; writing-review and editing. All authors approved final version submitted.

Corresponding author

Correspondence to Felipe Dal-Pizzol.

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Ethics Approval

The Ethics Committees of Hospital São José in Criciúma approved the study (Number: 4.449.750/2020 and CAAE number: 40641120.9.0000.5364) and all patients or proxies gave written informed consent, without any refusal. The study was registered in clinical trial = NCT04742322.

Consent to Participate

All patients or proxies gave written informed consent, without any refusal.

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All authors approved final version submitted.

Conflict of Interest/Competing Interests

Gabbia Biotechnology are developing B. lactis strain for the commercial purposes. Gabriel Jesus, Marina Rosseto, Ana Paula Voytena, and Fernanda Ramlov are members of Gabbia Biotechnology. The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

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Michels, M., Córneo, E., Cucker, L. et al. Bifidobacterium lactis CCT 7858 Improves Gastrointestinal Symptoms by Antibiotics Treatment: a Double-Blind, Randomized, Placebo-Controlled Trial. Probiotics & Antimicro. Prot. 15, 738–748 (2023). https://doi.org/10.1007/s12602-021-09900-6

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