Trial reportEuropean journal of nutrition2022
Probiotic Bifidobacterium lactis Probio-M8 treated and prevented acute RTI, reduced antibiotic use and hospital stay in hospitalized young children: a randomized, double-blind, placebo-controlled study.
Trial report in European journal of nutrition, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT04122495 (Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic), which is not on this map. Cited by 19 papers, 2 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment of Upper and Lower Respiratory Tract Infections in Young Children Using Probiotic
Who cites it
19 citing papers in PubMed, 2 syntheses or guidelines pooled it.
- Probiotic supplementation is associated with higher faecal secretory IgA (sIgA) in healthy full-term infants: a systematic review and meta-analysis.Pediatric research · 2026Pooled it
- Comparative efficacy and safety of probiotic for respiratory tract infections in children: a network meta-analysis.Frontiers in nutrition · 2026Pooled it
- Probiotic improves respiratory and gastrointestinal health, immune homeostasis, and gut microbiota composition in infants: a randomized controlled trial.Frontiers in nutrition · 2026Trial
- Probiotics and Fever Duration in Children With Upper Respiratory Tract Infections: A Randomized Clinical Trial.JAMA network open · 2025Trial
- Therapeutic Potential ofInternational journal of molecular sciences · 2025Trial
- Effects of Nasal Solution Incorporating Resveratrol and Carboxymethyl-Β-Glucan in Preschool Non-Atopic Children with Wheezing.Nutrients · 2024Trial
- The probioticGut microbesTrial
- Gut microbiota impact on lung diseases: a mini review of clinical evidence.Infection and immunity · 2026Review
- Comparative Immunomodulatory Profiles ofJournal of microbiology and biotechnology · 2026Article
- Metal-Phenolic Network-Directed Coating ofFoods (Basel, Switzerland) · 2025Article
- Shaping oral and intestinal microbiota and the immune system during the first 1,000 days of life.Frontiers in pediatrics · 2025Review
- Host tracheal and intestinal microbiomes inhibitMicrobiology spectrum · 2024Article
- An optimized culturomics strategy for isolation of human milk microbiota.Frontiers in microbiology · 2024Article
- Host tracheal and intestinal microbiomes inhibitbioRxiv : the preprint server for biology · 2023Article
- Probiotics alleviate constipation and inflammation in late gestating and lactating sows.NPJ biofilms and microbiomes · 2023Article
- The Role of Gut Bacteriome in Asthma, Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnoea.Microorganisms · 2022Review
- Gut Microbiota and COVID-19: Potential Implications for Disease Severity.Pathogens (Basel, Switzerland) · 2022Review
- Probiotics for immunomodulation in prevention against respiratory viral infections with special emphasis on COVID-19.AIMS microbiology · 2022Review
- The ProbioticFrontiers in nutrition · 2022Article
Corrections and comments
- Erratum issued
Authors and funding
15 authors.
Funding
Abstract
purposeThe development of probiotics has seen tremendous growth over the years, with health benefits ranging from gut health to respiratory. We thus aimed to investigate the effects of probiotic Bifidobacterium lactis Probio-M8 (2 × 10
methodA prospective, randomized, double-blind and placebo-controlled study was performed in RTI-hospitalized children. Patients were randomized to either the probiotic (n = 60, mean age 13.81 ± 0.90 months) or placebo (n = 60, mean age 12.11 ± 0.73 months) which were administered upon admission, continued during hospitalization and 4-week post-discharged. RTI and gut health parameters were assessed at these time points using validated questionnaires while concentrations of inflammatory cytokines were assessed via oral swabs.
resultsProbio-M8 reduced the duration of nasal, pharyngeal and general flu-like symptoms compared to the placebo during the hospitalization period and 4-week post-discharged (P < 0.05) as compared to the placebo, with a more prevalent effect against lower respiratory tract infections (LRTI). Probio-M8 reduced prescription of antibiotic (P = 0.037), prevented new prescription of antibiotic in non-prescribed patients (P = 0.024) and reduced hospitalization period in antibiotic-prescribed patients (P = 0.004) as compared to the placebo. Oral cytokine levels of TNF-α decreased in the Probio-M8 group (P = 0.001) accompanied by increased in IL-10 (P = 0.018) over 4-week post-discharged, while the placebo group did not exhibit such an effect. Increased IL-10 in the Probio-M8 group was correlated with decreased body ache (r = - 0.296, P = 0.001), headache (r = - 0.295, P = 0.001) and pain during swallow (r = - 0.235, P = 0.010).
conclusionData from our present study show that B. lactis Probio-M8 could be a potential natural and non-drug strategy for the management of RTI in young children in a safe manner. CLINICAL
trial registrationClinical studies (Approval No. USM/JEPeM/19030177) were registered at ClinicalTrials.gov (Identifier No. NCT04122495) on September 30, 2019.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.