scholarly journals Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial

2021 ◽  
pp. 1-12
Author(s):  
A. Damholt ◽  
M.K. Keller ◽  
K. Baranowski ◽  
B. Brown ◽  
A. Wichmann ◽  
...  
Keyword(s):  
General Practitioner ◽  
Respiratory Tract ◽  
Controlled Trial ◽  
Oral Intake ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Upper Respiratory ◽  
Tract Infections ◽  
Cluster 2

Acute upper respiratory tract infections (URTIs) are caused by numerous viruses and bacteria. URTIs can be a cause of morbidity and are among the most common reasons for visiting healthcare practitioners and prescribing antibiotics to children in addition to causing absenteeism from school and work. Oral intake of Lacticaseibacillus rhamnosus GG DSM 33156 has shown beneficial health effects in several clinical trials, primarily relating to immune function and gastrointestinal health in children and adults. It has also been suggested that oral intake of L. rhamnosus GG DSM 33156 can reduce the incidence rate and alleviate symptoms of URTIs in children. We here report the results of a randomised, double-blind, placebo-controlled trial of 619 children aged 2-6 years conducted at a single centre in Scotland. The children, who were in day care or primary school, were followed over a 16-week intervention period with 309 randomised in the active group and 310 in the placebo group. The parents or guardians reported a daily healthcare status and any presumed episodes of URTI, which were subsequently confirmed by a general practitioner. The investigational product was well tolerated in the trial. Although a general trend towards a beneficial effect was observed, this trial did not demonstrate that L. rhamnosus GG DSM 33156 significantly reduced the incidence of URTIs, diagnosed by a general practitioner according to prespecified criteria (primary endpoint). Moreover, none of the secondary efficacy endpoints were met. Applying a Ward’s hierarchical clustering, two separate clusters, focussing on four quality of life-related endpoints, were identified. Cluster 1 was associated with more severe URTI characteristics than cluster 2. Cluster 2 was significantly enriched with children who consumed the product, indicating that the symptoms children experience during an URTI are alleviated by the intake of L. rhamnosus GG DSM 33156. The study is registered at ClinicalTrials.gov ID: NCT03636191.

A Placebo Controlled, Double-Blind Evaluation of Levamisole in the Reduction of the Frequency, Duration and Severity of Attacks in Children Suffering from Recurrent Upper Respiratory Tract Infections

1979 ◽  
Vol 7 (4) ◽  
pp. 302-304 ◽  
Author(s):  
F Dils
Keyword(s):  
Respiratory Tract ◽  
Respiratory Tract Infections ◽  
Controlled Study ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Single Body ◽  
Upper Respiratory ◽  
Tract Infections ◽  
Adjusted Dose

In a double-blind placebo controlled study of levamisole in the treatment of children with recurrent upper respiratory tract infection (URI) eighty-six patients took part. Medication was given once a week, in a single body-weight adjusted dose. The children treated with levamisole had a statistically significantly reduced incidence of episodes of infection which were less severe, less prolonged and required less antibiotics. No side-effects were reported.

scholarly journals Results of a multicentre double-blind placebo-controlled randomized trial of the liquid form of Anaferon for children in the treatment of acute upper respiratory tract infections

2019 ◽  
Vol 64 (4) ◽  
pp. 105-113
Author(s):  
B. M. Blokhin ◽  
O. V. Shamsheva ◽  
N. L. Chernaya ◽  
I. G. Sitnikov ◽  
S. G. Lazareva ◽  
...  
Keyword(s):  
Placebo Group ◽  
Adverse Events ◽  
Respiratory Tract ◽  
Average Duration ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Randomized Clinical Study ◽  
Upper Respiratory ◽  
Tract Infections

Acute respiratory infections (ARI) are major causes of morbidity in children. Symptomatic treatment is insufficiently effective and requires additional drugs with etiotropic action. This multi-center double blind placebo-controlled randomized clinical study with superiority model design considers a liquid formulation of Anaferon for children.Methods. The study included 142 children from 1 month to 3 years 11 month 29 days old with ARI of the upper respiratory tract. They were randomized into Anaferon for children and Placebo groups (71 in each group) via interactive voice randomization system. The treatment period was 5 days, observation period – 14 days. The average duration of the symptoms and the severity of the respiratory disease were used as primary efficacy endpoints.Results. All 142 patients were randomized and included into ITT (Intention to treat) analysis. 140 patients (70 patients in each group) were included into PP-analysis. The patients in the Anaferon for children group had better results with average duration of ARI as compared to the Placebo group (87.7±31.5h vs. 103.3±19.4h; p =0.007). The authors marked efficacy of Anaferon for children in such parameters as disease severity (ITT-analysis: p=0.0004), total severity of disease symptoms (ITT-analysis: ANOVA: “Group” factor p=0.0004; “Day” factor p<0.0001), and percentage of recovered patients (Log-rank test, p=0.035). There were no discrepancies between the groups in concomitant therapy (ITT-analysis: ANOVA “Group-Day” factor p=0.88), bacterial complications frequency (p=1.0), adverse effects (Fisher criteria: p=0.5321). The authors registered 14 cases of adverse events (10 cases in Anaferon group and 4 cases in Placebo group) in 11 patients. None of the adverse events had a certain or probable relation to the studied drug.Conclusion. Anaferon for children proved their efficiency and safety in young children with ARI. 

scholarly journals Efficacy and safety of Aviron Rapid® in 18-60-year-old patients with clinical diagnosis of acute respiratory viral infection: a multicenter, randomized, double-blind, placebo-controlled clinical trial

Folia Medica ◽  
2021 ◽  
Vol 63 (1) ◽  
pp. 129-137
Author(s):  
Georgi Popov ◽  
Margarita Gospodinova-Bliznakova ◽  
Zlatko Kalvatchev ◽  
Andrey Tchorbanov
Keyword(s):  
Respiratory Tract ◽  
Viral Infection ◽  
Clinical Diagnosis ◽  
Symptomatic Therapy ◽  
Upper Respiratory Tract ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Duration Of Disease ◽  
Upper Respiratory ◽  
Tract Infections

Aim: Prevention and treatment of upper respiratory tract infections are given the highest priority because of the tremendous health and economic impact of these diseases. Development of novel effective and safe options for treatment can contribute considerably to decrease the burden of disease. Materials and methods: We designed a multicenter, randomized, double-blind, placebo-controlled study in ambulatory-treated adult patients with a clinical diagnosis of acute upper respiratory tract viral infection. The patients (18-60 years old) were randomized into two groups and followed-up for 5 days. Group 1 received the standard symptomatic therapy + Aviron Rapid&reg;, and Group 2 received the standard symptomatic therapy + placebo. The primary endpoint of the study was defined as the duration of disease measured by the percentages of disease-free patients for every 12-hour period of the study.&nbsp; Results: Treating clinically relevant patients with the natural product Aviron Rapid&reg; for 5 days decreases the duration of disease, the intake of antipyretics and the severity of symptoms. Significant difference between the tested groups for most of studied parameters was found as soon as 12 or 24 hours after initiation of administration in favour of active arm and was the most prominent on days 3 and 4. Significant decrease in the total score of symptoms severity was achieved on day 4 and extended to the end of study. There were no dif-ferences in the adverse events between the groups and the tested product demonstrated excellent safety profile.&nbsp; Conclusions: This study is a clinical confirmation of well documented antiviral activity of the product targeting multiple points in viral replication and covering broad spectrum viral pathogens.

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