Dataset Information

Efficacy of probiotics on digestive disorders and acute respiratory infections: a controlled clinical trial in young Vietnamese children.

ABSTRACT:

Objectives

To evaluate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) on the incidence of constipation, diarrhea, acute respiratory infections (ARI), and nutritional status of young Vietnamese children.

Methods

A controlled field trial was conducted with 1003 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n = 510) consumed fermented milk 65 mL/day containing 10⁸ CFU/mL of LcS for the 12-week intervention period, whereas the control group (n = 493) was not given any. The incidence of constipation, diarrhea, ARI, and anthropometry in children was determined at baseline, after 4, 8, and 12-week intervention, and after the 4-week follow-up period.

Results

Probiotic drink decreased the incidence of constipation after the 12-week intervention period (12.0% vs. 32.0%, OR = 0.28 (95% CI: 0.21-0.40), p < 0.001), tended to decrease the incidence of diarrhea (4.9% vs. 7.9%, OR = 0.60 (95% CI: 0.35-1.01), p = 0.068), and prevented the occurrence of ARI (15.9% vs. 24.5%, OR = 0.58 (95% CI: 0.42-0.79), p < 0.001), when compared with the control group. In contrast, no probiotic effects were observed for the duration of diarrhea or ARI. Weight gain was higher in the probiotic group than in the control group after 4, 8, and 12-week intervention and after the 4-week follow-up period (p < 0.05).

Conclusions

Daily intake of fermented milk containing LcS strongly prevented the incidence of constipation and ARI in Vietnamese children. This study also revealed the potential effects of the use of a probiotic drink on diarrhea prevention as well as nutritional status improvement.

SUBMITTER: Mai TT

PROVIDER: S-EPMC7943424 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Publications

Efficacy of probiotics on digestive disorders and acute respiratory infections: a controlled clinical trial in young Vietnamese children.

Mai Truong Tuyet TT Thi Thu Pham P Thi Hang Hoang H Trang Tran Thi Thu TTT Yui Shintaro S Shigehisa Akira A Tien Vu Thuy VT Dung Truong Viet TV Nga Phan Bich PB Hung Nguyen Trong NT Tuyen Le Danh LD

European journal of clinical nutrition 20200928 3

<h4>Objectives</h4>To evaluate the efficacy of fermented milk containing Lactobacillus casei strain Shirota (LcS) on the incidence of constipation, diarrhea, acute respiratory infections (ARI), and nutritional status of young Vietnamese children.<h4>Methods</h4>A controlled field trial was conducted with 1003 children (3-5 years old) in Thanh Hoa province in Vietnam. The probiotic group (n = 510) consumed fermented milk 65 mL/day containing 10<sup>8</sup> CFU/mL of LcS for the 12-week interventi ...[more]

PMID: 32981933

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Project description:ImportanceUpper respiratory tract infections (URTIs) are prevalent in children, prompting frequent health care consultations, especially among those with fever. Probiotics show potential as an adjuvant treatment for URTIs, but evidence in children is limited.ObjectiveTo evaluate the efficacy of a probiotic mixture containing Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001 in shortening fever duration among children with URTIs.Design, setting, and participantsThis randomized clinical trial was conducted between November 19, 2021, and June 20, 2023, at the pediatric emergency department of the Ca' Granda Ospedale Maggiore Policlinico in Milan, Italy. Patients between 28 days and 4 years of age with a fever (≥38.5 °C) and URTI were eligible. Exclusion criteria included recent probiotic use, chronic autoimmune diseases, immunosuppressive treatment, and requirement for hospitalization. Randomization was computer generated and assigned participants to either the intervention (probiotics) or control (placebo) group. Participants, parents or caregivers, and investigators were masked to the group assignments. The primary analysis followed the intention-to-treat approach.InterventionsThe probiotic group received daily single dose of 0.5 mL probiotic mixture containing Bifidobacterium breve M-16V, Bifidobacterium lactis HN019, and Lactobacillus rhamnosus HN001 for 14 days. The placebo group received daily single dose of 0.5 mL placebo for 14 days.Main outcomes and measuresThe primary outcome was fever duration, defined as the number of days between the first and the last days with fever.ResultsOf the 128 patients enrolled (69 males [54%]; mean [SD] age 2.5 [1.3] years), 65 (51%) were randomly assigned to receive placebo and 63 (49%) to receive probiotics. The median (IQR) fever duration was shorter in the probiotic group than the placebo group (median [IQR], 3 [2-4] days vs 5 [4-6] days; adjusted risk ratio, 0.64; 95% CI, 0.51-0.80). Few mild adverse events were reported and did not significantly differ between the probiotic and placebo groups, including constipation (6 [16%] and 6 [12%]; P = .80) and abdominal pain (3 [8%] and 2 [4%]; P = .65).Conclusions and relevanceIn this randomized clinical trial, administering a probiotic mixture reduced fever duration by 2 days compared with placebo, with no meaningful safety concerns. The probiotic mixture under investigation could be an effective adjuvant for shortening fever duration in children with URTIs.Trial registrationClinicalTrials.gov Identifier: NCT06052540.

Dataset Information

Efficacy of probiotics on digestive disorders and acute respiratory infections: a controlled clinical trial in young Vietnamese children.

Objectives

Methods

Results

Conclusions

Publications

Efficacy of probiotics on digestive disorders and acute respiratory infections: a controlled clinical trial in young Vietnamese children.

Similar Datasets

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