Development and pilot evaluation of a novel probiotic mixture for the management of seasonal allergic rhinitis

2010 ◽  
Vol 56 (9) ◽  
pp. 730-738 ◽  
Author(s):  
Tara Koyama ◽  
Pirkka V. Kirjavainen ◽  
Cale Fisher ◽  
Kingsley Anukam ◽  
Kelly Summers ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Controlled Trial ◽  
Eosinophil Cationic Protein ◽  
Lactobacillus Rhamnosus ◽  
Allergic Diseases ◽  
Double Blind ◽  
Cationic Protein ◽  
Bifidobacterium Adolescentis ◽  
Probiotic Group

Microbial exposure may direct the immune system away from allergic-type responses, but until now probiotic interventions have had limited success in the prevention and treatment of allergic diseases. In this study, a novel probiotic mixture was specifically created based on preliminary in vitro investigations on pollen-induced immune responses. A mixture with Lactobacillus rhamnosus GR-1 and a novel fecal Bifidobacterium adolescentis isolate was formulated into a yogurt and tested for its effects in 36 subjects with allergic rhinitis over 2 pollen seasons in a double-blind, placebo-controlled trial. The new formulation was well tolerated, but did not have significant effects on the quality of life scores, use of antihistamines, or eosinophil cationic protein concentration in nasal lavage. However, at the end of the grass pollen season, serum IL-10 and IL-12 levels were increased in the probiotic group compared to the controls. During the ragweed season, the serum TGF-β levels were significantly higher in the probiotic group than in the controls. In conclusion, the novel probiotic formulation had potentially desirable effects on the cytokine profile of patients with allergic rhinitis, but provided few clinical benefits. The study highlights the challenges in designing efficient immunomodulatory probiotic therapies based upon in vitro findings.

scholarly journals Probiotic therapy on children with allergic rhinitis

2016 ◽  
Vol 53 (5) ◽  
pp. 264
Author(s):  
Franky Luhulima ◽  
IPG Karyana ◽  
Sumadiono Sumadiono
Keyword(s):  
Allergic Rhinitis ◽  
Placebo Group ◽  
Standard Therapy ◽  
Controlled Trial ◽  
Nasal Symptom ◽  
Probiotic Supplementation ◽  
Double Blind ◽  
Probiotic Group ◽  
Probiotic Treatment ◽  
Nasal Secretions

phils in nasal secretions of patients with allergic rhinitis may cause persistent nasal blockage. A common therapy for allergic rhinitis is oral or intranasal corticosteroids. However, corticosteroids carry the risk of disrupting growth and development in children. Probiotic treatment in allergic rhinitis patients works by manipulating the bacterial ecosystem of the digestive tract, stimulating the balance of Th1 and Th2 immune responses.Objective To assess the effects of probiotic supplementation on eosinophil levels in nasal secretions, duration of allergic episodes, and total nasal symptom scores in children aged 2-18 years with allergic rhinitis.Methods A randomized, double-blind, controlled trial was performed on children aged 2 to 18 years who visited Sanglah Hospital, Denpasar, between March to July 2012 due to allergic rhinitis. Fifty-five eligible subjects were involved in the study. Subjects were randomly allocated to receive either standard therapy (antihistamines) and probiotics or standard therapy and placebo for 30 days. Mann-Whitney test was used for statistical non-parametric unpaired samples analysis. P values of <0.05 were considered to be statistically significant.Results Fifty-five subjects with allergic rhinitis were randomized into either the probiotic group (27 subjects) or the placebo group (28 subjects). We found that the median (range) nasal eosinophil percentage reduction before the study compared to after 30 days of treatment was higher in the probiotic group than in the placebo group (34 (15-65) vs 6 (0-24) %, respectively, P<0.0001). Median (range) duration of allergic rhinitis episode in the probiotic group was shorter compared to the placebo group (48 (0-96) hours vs 72 (6-168) hours, respectively; P<0.0001). The median (range) total nasal symptom score was also lower in the probiotic group compared to the placebo group (2 (0-3) vs 5 (1-6), respectively; P<0.0001).Conclusion Probiotic supplementation reduces the percentage of nasal eosinophils, duration of allergic rhinitis episode, and total nasal symptoms.

Improved cure of bacterial vaginosis with single dose of tinidazole (2 g),Lactobacillus rhamnosusGR-1, andLactobacillus reuteriRC-14: a randomized, double-blind, placebo-controlled trial

2009 ◽  
Vol 55 (2) ◽  
pp. 133-138 ◽  
Author(s):  
Rafael C. R. Martinez ◽  
Sílvio A. Franceschini ◽  
Maristela C. Patta ◽  
Silvana M. Quintana ◽  
Bruna C. Gomes ◽  
...  
Keyword(s):  
Single Dose ◽  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
Antimicrobial Treatment ◽  
Double Blind ◽  
Probiotic Group ◽  
Probiotic Lactobacilli

Bacterial vaginosis (BV) is the most prevalent vaginal infection worldwide and is characterized by depletion of the indigenous lactobacilli. Antimicrobial therapy is often ineffective. We hypothesized that probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 might provide an adjunct to antimicrobial treatment and improve cure rates. Sixty-four Brazilian women diagnosed with BV were randomly assigned to receive a single dose of tinidazole (2 g) supplemented with either 2 placebo capsules or 2 capsules containing L. rhamnosus GR-1 and L. reuteri RC-14 every morning for the following 4 weeks. At the end of treatment (day 28), the probiotic group had a significantly higher cure rate of BV (87.5%) than the placebo group (50.0%) (p = 0.001). In addition, according to the Gram-stain Nugent score, more women were assessed with “normal” vaginal microbiota in the probiotic group (75.0% vs. 34.4% in the placebo group; p = 0.011). This study shows that probiotic lactobacilli can provide benefits to women being treated with antibiotics for an infectious condition.

scholarly journals Intralymphatic immunotherapy with tyrosine-adsorbed allergens: a double-blind, placebo-controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Hye Jung Park ◽  
Sae-Hoon Kim ◽  
Yoo Seob Shin ◽  
Chul Hwan Park ◽  
Eun-Suk Cho ◽  
...  
Keyword(s):  
Allergic Rhinitis ◽  
Injection Site ◽  
Symptom Score ◽  
Therapeutic Efficacy ◽  
Controlled Trial ◽  
Life Questionnaire ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Medication Score ◽  
Allergen Extracts

Abstract Background Most previous studies used aluminum hydroxide-absorbed allergen extracts in evaluating the potential therapeutic roles of intralymphatic allergen-specific immunotherapy (ILAIT). In this study, we evaluated the therapeutic efficacy and safety of ILAIT with L-tyrosine-adsorbed allergen extracts of Dermatophagoides farinae, D. pteronyssinus, cat, dog, or mixtures thereof, in patients with allergic rhinitis induced by these allergens. Methods In this randomized, double-blind, placebo-controlled trial, study subjects received three intralymphatic injections of L-tyrosine-adsorbed allergen extracts (active group) or saline (placebo group) at 4-week intervals. Results Although ILAIT reduced daily medication use and skin reactivity to HDM and cat allergens at 4 months after treatment, overall symptom score on a visual analog scale (VAS), sinonasal outcome test-20 (SNOT-20), rhinoconjunctivitis quality of life questionnaire (RQLQ), daily symptom score (dSS), daily medication score (dMS), daily symptom medication score (dSMS), nasal reactivity to HDM allergen, and basophil activity to HDM, cat, and dog allergens at 4 months and 1 year after treatment were similar between the treatment and control groups. Intralymphatic injection was more painful than a venous puncture, and pain at the injection site was the most frequent local adverse event (12.8%); dyspnea and wheezing were the most common systemic adverse events (5.3%). Conclusions ILAIT with L-tyrosine-adsorbed allergen extracts does not exhibit profound therapeutic efficacy in allergic rhinitis and can provoke moderate-to-severe systemic reactions and cause pain at the injection site. Trial registration: clinicaltrials.gov: NCT02665754; date of registration: 28 January 2016

scholarly journals Azithromycin and hydroxychloroquine in hospitalised patients with confirmed COVID-19–a randomised double-blinded placebo-controlled trial

2021 ◽  
pp. 2100752
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Therese Sophie Lapperre ◽  
Rasmus Dahlin Bojesen ◽  
Josefin Eklöf ◽  
...  
Keyword(s):  
Primary Outcome ◽  
Controlled Trial ◽  
Intervention Group ◽  
Control Group ◽  
Double Blind ◽  
Safety Outcome ◽  
Hospitalised Patients ◽  
Double Blinded ◽  
Combined Intervention

BackgroundCombining the antibiotic azithromycin and hydroxychloroquine induces airway immunomodulatory effects, with the latter also having in vitro antiviral properties. This may improve outcomes in patients hospitalised for COVID-19.MethodsPlacebo-controlled double-blind randomised multicentre trial. Patients ≥18 years, admitted to hospital for≤48 h (not intensive care) with a positive SARS-CoV-2 RT-PCR test, were recruited. The intervention was 500 mg daily azithromycin for 3 days followed by 250 mg daily azithromycin for 12 days combined with 200 mg twice daily hydroxychloroquine for all 15 days. The control group received placebo/placebo. The primary outcome was days alive and discharged from hospital within 14 days (DAOH14).ResultsAfter randomisation of 117 patients, at the first planned interim analysis, the data and safety monitoring board recommended stopping enrolment due to futility, based on pre-specified criteria. Consequently, the trial was terminated on February 1, 2021. A total of 61 patients received the combined intervention and 56 patients received placebo. In the intervention group, patients had a median of 9.0 DAOH14 (IQR, 3–11) versus. 9.0 DAOH14 (IQR, 7–10) in the placebo group (p=0.90). The primary safety outcome, death from all causes on day 30, occurred for 1 patient in the intervention group versus. 2 patients receiving placebo (p=0.52), and readmittance or death within 30 days occurred for 9 patients in the intervention group versus. 6 patients receiving placebo (p=0.57).ConclusionsThe combination of azithromycin and hydroxychloroquine did not improve survival or length of hospitalisation in patients with COVID-19.

scholarly journals Efficacy and safety of Ivermectin and Hydroxychloroquine in patients with severe COVID-19. A randomized controlled trial

2021 ◽  
Author(s):  
Jose Lenin Beltran Gonzalez ◽  
Mario González Gámez ◽  
Emanuel Antonio Mendoza Enciso ◽  
Ramiro Josue Esparza Maldonado ◽  
Daniel Hernández Palacios ◽  
...  
Keyword(s):  
Respiratory Failure ◽  
Controlled Trial ◽  
Total Duration ◽  
Severe Respiratory Failure ◽  
Double Blind ◽  
Arterial Blood ◽  
Duration Of Hospitalization ◽  
Group 3 ◽  
Group 2

AbstractBackgroundIn the search for active drugs against COVID-19, the indications of many have been redirected. Ivermectin and Hydroxychloroquine are drugs that inhibit viral replication in vitro and that have been used in several medical centers.ObjectivesThis clinical trial analyzes the efficacy of Ivermectin and Hydroxychloroquine in patients with moderate COVID-19 and in need of hospitalization.MethodsThis a controlled, clinical, randomized, double-blind trial that included patients with COVID-19-induced pneumonia and hospitalization criteria, but no severe respiratory failure. Patients were randomized to one of three groups: Group1-hydroxychloroquine, 400 mg every 12 hours on the first day and subsequently, 200 mg every 12 hours for 4 days, Group 2-ivermectin, 12 mg or 18 mg, according to patient weight and, Group 3-placebo. At inclusion, blood samples for arterial blood gases and biochemical markers associated with a poor prognosis were obtained. The primary outcome was established as the duration of hospitalization until discharge due to patient improvement, the total duration of hospitalization, and the safety outcomes were either respiratory deterioration or death.ResultsDuring the month of August, the admission of patients requiring hospitalization mostly encompassed cases with severe respiratory failure, so we ended the recruitment process and analyzed the data that was available at the time. One hundred and six (106) patients with an average age of 53 yrs. (±16.9) were included, with a greater proportion of males (n=66, 62.2 %). Seventy-two percent (72%) (n= 76) had an associated comorbidity. Ninety percent (90 %) of patients were discharged due to improvement (n=96). The average duration of hospitalization was 6 days (IQR, 3 – 10). No difference in hospitalization duration was found between the treatment groups (Group1: 7 vs Group 2: 6 vs Group 3: 5, p=0.43) nor in respiratory deterioration or death (Group 1: 18 % vs Group 2: 22.2 % vs Group 3: 24.3 %, p =0.83).ConclusionsIn non-critical hospitalized patients with COVID-19 pneumonia, neither ivermectin nor hydroxychloroquine decreases the number of in-hospital days, respiratory deterioration, or deaths.ClinicalTrials identifier NCT04391127

scholarly journals Efficacy of a nasal spray containing Iota-Carrageenan in the prophylaxis of COVID-19 in hospital personnel dedicated to patients care with COVID-19 disease. A pragmatic multicenter, randomized, double-blind, placebo-controlled trial (CARR-COV-02)

2021 ◽  
Author(s):  
Juan Manuel Figueroa ◽  
Monica Lombardo ◽  
Ariel Dogliotti ◽  
Luis Flynn ◽  
Robert P. Giugliano ◽  
...  
Keyword(s):  
Placebo Group ◽  
Nasal Spray ◽  
Controlled Trial ◽  
Hospital Personnel ◽  
Culture Methods ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Significant Efficacy ◽  
To Receive

Background Iota-Carrageenan (I-C) is a sulfate polysaccharide synthesized by red algae, with demonstrated antiviral activity and clinical efficacy as nasal spray in the treatment of common cold. In vitro, I-C inhibits SARS-CoV-2 infection in cell culture. Methods This is a pragmatic multicenter, randomized, double-blind, placebo-controlled trial assessing the use of a nasal spray containing I-C in the prophylaxis of COVID-19 in hospital personnel dedicated to care of COVID-19 patients. Clinically healthy physicians, nurses, kinesiologists and others medical providers were assigned in a 1:1 ratio to receive four daily doses of I-C spray or placebo for 21 days. The primary end point was clinical COVID-19, as confirmed by reverse-transcriptase-polymerase-chain-reaction testing, over a period of 21 days. The trial is registered at ClinicalTrials.gov (NCT04521322). Findings A total of 394 individuals were randomly assigned to receive I-C or placebo. Both treatment groups had similar baseline characteristics. The incidence of COVID-19 was significantly lower in the I-C group compared to placebo (1.0% vs 5.0%) (Odds Ratio 0.19 (95% confidence interval 0.05 to 0.77; p= 0.03). Workday loss in placebo group compared to I-C were 1.6% days / person (95% CI, 1.0 to 2.2); p <0.0001 There were no differences in the incidence of adverse events across the two groups (17.3% in the I-C group and 15.2% in the placebo group, p= 0.5). Interpretation I-C showed significant efficacy in preventing SARS-CoV-2 infection in hospital personnel dedicated to care patients with COVID-19 disease.

Sign in / Sign up

Export Citation Format

Share Document