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 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.

scholarly journals Role of probiotics in lower reproductive tract infection in women of age group 18 to 45 years

2017 ◽  
Vol 6 (2) ◽  
pp. 671
Author(s):  
Rukshana Shamshu ◽  
Jayasree Vaman ◽  
Nirmala C.
Keyword(s):  
Bacterial Vaginosis ◽  
Lactobacillus Reuteri ◽  
Lactobacillus Rhamnosus ◽  
Vulvovaginal Candidiasis ◽  
Controlled Study ◽  
Control Group ◽  
P Value ◽  
Double Blind ◽  
Reproductive Tract Infection ◽  
Conventional Antibiotics

Background: This study has been designed to assess the effectiveness of the probiotic strains having Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 in the management of lower genital infections (bacterial vaginosis and candidiasis) as an integral therapy with antibiotics.Methods: Double blind, randomized placebo controlled study in women between 18-45 years attending Sree Avittom Thirunal Hospital (SATH), Government Medical College, Thiruvananthapuram, India with symptoms of bacterial vaginosis and vulvovaginal candidiasis. Women giving consent were given probiotics along with conventional antibiotics and were followed up over a period of two months. Outcome is measured as percentage of women showing a score of less than 4 at the end of thirty days of treatment, and sixty days of treatment in the test and control group in the case of bacterial vaginosis and no discharge and absence of hyphae and pseudohyphae in wet smear and gram stain in case of candidiasis.Results: Out of 42 women studied, 32 had bacterial vaginosis and 10 had vulvovaginal candidiasis. 81.3% women with BV had a normal vaginal picture after sixty days of treatment as compared to placebo which was only 31.3%. The p value is 0.004 which is significant. In the treatment of VC, the percentage of women cured was the same in both probiotic and placebo group.Conclusions: In the treatment of bacterial vaginosis, addition of probiotics to the conventional antibiotics can improve the cure rate of bacterial vaginosis and reduce the rate of recurrences. In the treatment of vulvovaginal candidiasis, addition of probiotics to the conventional antifungal did not have a significant improvement.

scholarly journals Lactobacillus reuteri DSM 17938 and Agave Inulin in Children with Cerebral Palsy and Chronic Constipation: A Double-Blind Randomized Placebo Controlled Clinical Trial

Nutrients ◽  
2020 ◽  
Vol 12 (10) ◽  
pp. 2971
Author(s):  
Andrea García Contreras ◽  
Edgar Vásquez Garibay ◽  
Carmen Sánchez Ramírez ◽  
Mary Fafutis Morris ◽  
Vidal Delgado Rizo
Keyword(s):  
Cerebral Palsy ◽  
Placebo Group ◽  
Chronic Constipation ◽  
Lactobacillus Reuteri ◽  
Controlled Clinical Trial ◽  
Double Blind ◽  
Probiotic Group ◽  
Fecal Mass ◽  
Children With Cerebral Palsy ◽  
History Of

The main objective was to assess the efficacy of a probiotic (Lactobacillus reuteri DSM 17938), a prebiotic (agave inulin), and a synbiotic on the stool characteristics in children with cerebral palsy and chronic constipation. Thirty-seven children with cerebral palsy and chronic constipation were included. The probiotic group received 1 × 108 colony forming unit (cfu) of L. reuteri DSM 17938 plus placebo, the prebiotic group received 4 g of agave inulin plus placebo, the synbiotic group received L. reuteri DSM 17938 plus agave inulin, and the placebo group received two placebos for 28 days. The probiotic group showed a significant decrease in stool pH (p = 0.014). Stool consistency improved in the prebiotic group (p = 0.008). The probiotic, prebiotic, and synbiotic groups showed a significant improvement in the history of excessive stool retention, the presence of fecal mass in the rectum, and the history of painful defecation. L. reuteri concentration in feces was higher in the probiotic group than in the placebo group (p = 0.001) and showed an inverse correlation with stool pH in the probiotic group (r = −0.762, p = 0.028). This study showed that the use of L. reuteri DSM 17938 and/or agave inulin improved the stool characteristics such as the history of painful defecation and the presence of fecal mass in the rectum against placebo in children with cerebral palsy and chronic constipation.

scholarly journals Effectiveness of Oral Probiotics as Adjuvant Therapy in Reproductive Aged Women with Vaginal Discharge

2018 ◽  
pp. 3
Author(s):  
Junita Indarti ◽  
Utomo Budidarmo
Keyword(s):  
Sample Size ◽  
Vaginal Discharge ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Lactobacillus Rhamnosus ◽  
P Value ◽  
Conditional Power ◽  
Satisfaction Level ◽  
Double Blind ◽  
Reproductive Aged Women

  Objective: To investigate the efficacy of oral proboiotics and prove the high proportion of cure and satisfaction levels of post-treatment patients with a combination of antimicrobial-probiotic oral Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 compared to a combination of antimicrobial-placebo in the treatment of reproductive aged patients with vaginal discharge in the outpatient obstetrics and gynecologic clinic in Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesia and Arifin Achmad Regional Hospital Pekanbaru, Riau, Indonesia. Methods:This was a randomized, double-blind, placebo-controlled trial involving50 subjects consisting of reproductive aged women. Data were collected using syndromic approach, probiotics were given as an adjuvant for standard antimicrobial therapy versus placebo as control, response was recorded 4 weeks later, for cure proportion and satisfaction level. Statistical analysis was performed to assess the variables. Interim analysis with conditional power assesment and futility testing were performed at midway due to insufficient sample size. Research was approved by Ethics Commitee for Health Researches Faculty of Medicine University of Indonesia-Dr. Cipto Mangunkusumo Hospital in March 2016. Results: A total of 50 subjects participated in this study. and analyzed (25 subjects in each group), cure proportion 56%(14) of the treatment and 60%(15)on the control group, with relative risk of 1.1, Chi-square test p value (0.77, 95% CI; 0.57 to 2 , 11). High satisfaction level (score ≥67) was higher in the placebo (52,6%, 10 subjects) compared to probiotic group (47,4%, 9 subjects), p value 0,65 (≥0,05). Conditional power and futility testing curve, revealed Z = -0.2865, conditional power 0.11 to 0.13, and futility index of 0.87 to 0.88, equals to low possibility of statistical significance with full sample size (84). Conclusion: There was no clinical and statistical difference in the proportion of cure rate and the level of satisfaction in patients of probiotics vs placebo groups after treatment for 4 weeks. The initial hypothesis of higher proportion of the cure ratein the treatment group still cannot be excluded, due to insufficient samples. Keywords: bacterial vaginosis, , lactobacillus reuteri RC-14, lactobacillus rhamnosus GR-1, randomized double blind controlled trial, trichomoniasis , vaginal discharge,  vulvovaginal candidiasis.

scholarly journals Evaluation of the Efficacy of Probiotics in the Treatment of Infantile Colic; a Randomized, Double Blind; Placebo Controlled Trial

2020 ◽  
Author(s):  
Mojdeh Habibi Zoham ◽  
Fatemeh Zafar ◽  
Armen Malekiantaghi ◽  
Reyhaneh Ettehadi ◽  
Seyed Behnam Jazayeri ◽  
...  
Keyword(s):  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Demographic Data ◽  
Intervention Group ◽  
Lactobacillus Rhamnosus ◽  
Infantile Colic ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
Potential Strategy

The infantile colic is one of the most common complaints in the infancy; however, limited therapeutic approaches are described in the literature. Recently probiotics have been suggested as a potential strategy in the treatment of infantile colic. We conducted this study to investigate the efficacy of probiotics in relieving colic symptoms in Iranian infants. This double-blind clinical trial was performed among 70 infants aged 3 to 16 weeks with the presumed diagnosis of infantile colic according to Wessel criteria who were breastfed or formula fed. They were assigned at random to receive Pedilact® (Bifidobacterium infantis, Lactobacillus reuteri, and Lactobacillus rhamnosus) (N=33) or placebo (N=32). Demographic data were recorded in the questionnaires at the beginning of the study. The number of daily episodes of crying and fussiness, number of weekly crying days, and duration of crying were separately analyzed on 7, 21, and 30th  days of investigation. Baseline demographic data showed no statistically significant difference between intervention and placebo groups. Infants given Pedilact® showed a significant reduction in daily episodes of crying, duration of crying, and the weekly number of crying days at the end of the treatment period compared with those receiving placebo (P=0.000). On 21th day of the study, daily episodes of fuss and crying (P=0.032) and duration of crying reduced significantly in the intervention group in comparison to the placebo group (P=0.000). Administration of Pedilact® drop significantly improved colic symptoms by reducing crying and fussing times in breastfed or formula fed in Iranian infants with colic. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(7):405-411.

The effects of a multispecies probiotic supplement on inflammatory markers and episodic and chronic migraine characteristics: A randomized double-blind controlled trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 841-853 ◽  
Author(s):  
Fahimeh Martami ◽  
Mansoureh Togha ◽  
Maryam Seifishahpar ◽  
Zeinab Ghorbani ◽  
Hossein Ansari ◽  
...  
Keyword(s):  
Placebo Group ◽  
Chronic Migraine ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Double Blind ◽  
Necrosis Factor Alpha ◽  
Probiotic Group ◽  
Mean Frequency ◽  
The Mean ◽  
Episodic Migraineurs

Background The current study was designed to assess the effect of supplementation with a 14-strain probiotic mixture on episodic and chronic migraine characteristics. Methods Forty episodic and 39 chronic migraine patients who completed this randomized double-blind controlled trial received two capsules of multispecies probiotic or placebo. The migraine severity was assessed by visual analog scale (VAS). The number of abortive drugs consumed, migraine days, frequency and duration of attacks were recorded on paper-based headache diaries. Serum tumor necrosis factor alpha (TNF-α) and C- reactive protein (CRP) levels were measured at baseline and the end of the intervention. Results After a 10-week intervention, among episodic migraineurs the mean frequency of migraine attacks significantly reduced in the probiotic group compare to the placebo group (mean change: −2.64 vs. 0.06; respectively, p < 0.001). A significant reduction was also evident in the migraine severity (mean decrease: −2.14 in the probiotic group and 0.11 in the placebo group; p < 0.001). Episodic migraineurs who received the probiotic also showed significant reduction in abortive drug usage per week (mean change: −0.72; p < 0.001) compare to baseline, while there was no significant changes within the placebo group. In chronic migraine patients, after an 8-week intervention, the mean frequency of migraine attacks significantly reduced in the probiotic compared to the placebo group (mean change: −9.67 vs. −0.22; p ≤ 0.001). In contrast to the placebo, probiotic supplementation significantly decreased the severity (mean changes: −2.69; p ≤ 0.001), duration (mean changes: −0.59; p ≤ 0.034) of attacks and the number of abortive drugs taken per day (mean changes: −1.02; p < 0.001), in chronic migraine patients. We failed to detect any significant differences in the serum levels of inflammatory markers at the end of the study either in chronic or in episodic migraineurs. Discussion The results of this study showed that the 14-strain probiotic mixture could be an effective and beneficial supplement to improve migraine headache in both chronic and episodic migraineurs. Further research is required to confirm our observations.

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 The Efficacy of Lactobacillus plantarum as Adjunctive Therapy of Bacterial Vaginosis: A Double-blind, Randomized, Placebo-controlled Trial

2020 ◽  
Vol 32 (3) ◽  
pp. 214
Author(s):  
Ridha Ramadina Widiatma ◽  
Muhammad Yulianto Listiawan ◽  
Dwi Murtiastutik ◽  
Cita Rosita Sigit Prakoeswa ◽  
Sawitri Sawitri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Plantarum ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
Vaginal Flora ◽  
Control Group ◽  
Therapeutic Effects ◽  
Cure Rate ◽  
Double Blind

Background: Bacterial vaginosis (BV) is a clinical syndrome caused by the changing of Lactobacillus spp., a producer of hydrogen peroxide, in the normal vagina with a high concentration of anaerobic bacteria, Gardnerella vaginalis and Mycoplasma hominis. This study reports a resistance of BV therapy regimens, high recurrence rates, and side effects of an antibiotic. Therefore, adjunctive therapy for BV management is needed. Research has reported the therapeutic effects of probiotic in BV; however, the results are inconsistent. Purpose: To evaluate the efficacy of standard therapy using metronidazole and Lactobacillus plantarum for BV measured by the cure rate and vaginal flora balance. Methods: A randomized, double-blind, placebo-controlled trial, 30 subjects were randomized to take metronidazole 500 mg twice a day for seven days with weekly evaluation. The Lactobacillus plantarum or placebo group was evaluated every 4 weeks. The cure rate and vaginal flora balance were evaluated using the Amsel criteria and Nugent score before and after the intervention. Result: A total of 30 subjects returned for 28-day follow-up, of which 60% subjects of the antibiotic/probiotic group were cured compared to 40% in the antibiotic/placebo group (p>0.05). Conclusion: There was no difference in the increase of cure rate and vaginal flora balance between the treatment group and significant control group.

scholarly journals Efficacy and Safety of a Naphthoquine-Azithromycin Co-Formulation for Malaria Prophylaxis in Southeast Asia: A Phase 3, Double-Blind, Randomized, Placebo-Controlled Trial

2020 ◽  
Author(s):  
Henglin Yang ◽  
Jingyan Wang ◽  
Hui Liu ◽  
Yan Zhao ◽  
Seetha Lakshmi ◽  
...  
Keyword(s):  
Single Dose ◽  
Placebo Group ◽  
Protective Efficacy ◽  
Controlled Trial ◽  
Fixed Dose ◽  
Phase 3 ◽  
Double Blind ◽  
Intent To Treat ◽  
Transient Elevation ◽  
Double Blinded

Abstract Background A prophylactic antimalarial drug that is both effective for protection and improves compliance is in high demand. Methods We conducted a randomized, placebo-controlled, double-blinded, phase-3 trial to evaluate the 1:1 fixed-dose combination of naphthoquine-azithromycin (NQAZ) for safety and protection against Plasmodium infections in villages along the China-Myanmar border. A total of 631 residents, 5–65 years old, were randomized into the drug group (319) and the placebo group (312) to receive NZAQ and placebo, respectively, as a single-dose monthly treatment. Follow-ups were conducted weekly to monitor for adverse events and malaria infections. Results Of the 531 subjects completing the trial, there were 46 and 3 blood smear-positive Plasmodium infections in the placebo and treatment groups, respectively. For the intent-to-treat analysis, the single-dose monthly NQAZ treatment had 93.62% protective efficacy (95% confidence interval [CI]: 91.72–95.52%). For the per-protocol analysis, NQAZ treatment provided a 93.04% protective efficacy (95% CI: 90.98–95.1%). Three smear-positive cases in the NQAZ group were all due to acute falciparum malaria. In comparison, NQAZ treatment provided 100% protection against the relapsing malaria Plasmodium vivax and Plasmodium ovale. The treatment group had 5.6% of participants experiencing transient elevation of liver transaminases as compared to 2.2% in the placebo group (P &gt; 0.05). Conclusions Monthly prophylaxis with NQAZ tablets was well tolerated and highly effective for preventing Plasmodium infections. It may prove useful for eliminating P. vivax in areas with a high prevalence of glucose-6-phosphate dehydrogenase deficiency in the population.

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