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.

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 The Effect of Probiotics on Childhood Constipation: A Randomized Controlled Double Blind Clinical Trial

2014 ◽  
Vol 2014 ◽  
pp. 1-5 ◽  
Author(s):  
M. Sadeghzadeh ◽  
A. Rabieefar ◽  
P. Khoshnevisasl ◽  
N. Mousavinasab ◽  
K. Eftekhari
Keyword(s):  
Abdominal Pain ◽  
Weight Gain ◽  
Fecal Incontinence ◽  
Controlled Trial ◽  
Intervention Group ◽  
Double Blind ◽  
Positive Role ◽  
Randomized Controlled ◽  
Double Blind Clinical Trial

Background. Inconsistent data exist about the role of probiotics in the treatment of constipated children. The aim of this study was to investigate the effectiveness of probiotics in childhood constipation.Materials and Methods. In this placebo controlled trial, fifty-six children aged 4–12 years with constipation received randomly lactulose plus Protexin or lactulose plus placebo daily for four weeks. Stool frequency and consistency, abdominal pain, fecal incontinence, and weight gain were studied at the beginning, after the first week, and at the end of the 4th week in both groups.Results. Forty-eight patients completed the study. At the end of the fourth week, the frequency and consistency of defecation improved significantly (P=0.042andP=0.049, resp.). At the end of the first week, fecal incontinence and abdominal pain improved significantly in intervention group (P=0.030andP=0.017, resp.) but, at the end of the fourth week, this difference was not significant (P=0.125andP=0.161, resp.). A significant weight gain was observed at the end of the 1st week in the treatment group.Conclusion. This study showed that probiotics had a positive role in increasing the frequency and improving the consistency at the end of 4th week.

scholarly journals Effect of vitamin D supplementation on selected inflammatory biomarkers in older adults: a secondary analysis of data from a randomised, placebo-controlled trial

2015 ◽  
Vol 114 (5) ◽  
pp. 693-699 ◽  
Author(s):  
Mary Waterhouse ◽  
Bich Tran ◽  
Peter R. Ebeling ◽  
Dallas R. English ◽  
Robyn M. Lucas ◽  
...  
Keyword(s):  
Vitamin D ◽  
Placebo Group ◽  
Inflammatory Markers ◽  
Controlled Trial ◽  
Intervention Group ◽  
Vitamin D Supplementation ◽  
Post Intervention ◽  
Double Blind ◽  
Specific Patient ◽  
Significant Difference

AbstractObservational studies have suggested that 25-hydroxyvitamin D (25(OH)D) levels are associated with inflammatory markers. Most trials reporting significant associations between vitamin D intake and inflammatory markers used specific patient groups. Thus, we aimed to determine the effect of supplementary vitamin D using secondary data from a population-based, randomised, placebo-controlled, double-blind trial (Pilot D-Health trial 2010/0423). Participants were 60- to 84-year-old residents of one of the four eastern states of Australia. They were randomly selected from the electoral roll and were randomised to one of three trial arms: placebo (n 214), 750 μg (n 215) or 1500 μg (n 215) vitamin D3, each taken once per month for 12 months. Post-intervention blood samples for the analysis of C-reactive protein (CRP), IL-6, IL-10, leptin and adiponectin levels were available for 613 participants. Associations between intervention group and biomarker levels were evaluated using quantile regression. There were no statistically significant differences in distributions of CRP, leptin, adiponectin, leptin:adiponectin ratio or IL-10 levels between the placebo group and either supplemented group. The 75th percentile IL-6 level was 2·8 pg/ml higher (95 % CI 0·4, 5·8 pg/ml) in the 1500 μg group than in the placebo group (75th percentiles:11·0 v. 8·2 pg/ml), with a somewhat smaller, non-significant difference in 75th percentiles between the 750 μg and placebo groups. Despite large differences in serum 25(OH)D levels between the three groups after 12 months of supplementation, we found little evidence of an effect of vitamin D supplementation on cytokine or adipokine levels, with the possible exception of IL-6.

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 The effects of pulsatile flushing on phlebitis and peripheral intravenous catheters patency

2020 ◽  
pp. 16-25
Keyword(s):  
Clinical Setting ◽  
Intervention Group ◽  
Practical Method ◽  
Control Group ◽  
Control Groups ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
Significant Difference ◽  
And Control ◽  
Intravenous Catheters

Background and Aim: Thrombophlebitis is considered as a major cause of peripheral intravenous catheters (PICs) failure. The flushing technique in the laboratory has been effective in clearing the catheter duct, but its effectiveness in the clinical setting is unknown, therefore, the aim of this study was to determine the effect of pulsatile flushing on phlebitis, type, and duration of PICs patency in patients. Materials and Methods: In this double-blind clinical trial, 71 patients admitted to the inpatient and surgical wards of Imam Khomeini Esfarayen Hospital were randomly assigned to the intervention and control groups after sampling by available methods. In the intervention group, the flushing technique was performed by injecting 1 ml of the normal saline solution for one second, then interrupting less than one second and repeating the injection and interrupting until the end of 5 ml of the solution. The Consequences of this study were phlebitis, duration, and type of PICs patency, which were evaluated every 12 hours by using Jackson's phlebitis instrument and direct observation of the catheter. Results: The incidence of phlebitis in the intervention group was lower than the control group (P<0.001). In addition, two groups had a statistically significant difference in the type of PICs (P<0.001). The median duration of PICs patency in the intervention group was significantly higher than the control group (P<0.001). Conclusion: Pulsatile flushing is an effective technique to increase longevity of PICs and recommended as a practical method in clinical setting.

Randomised double blind placebo controlled trial on Lactobacillus reuteri DSM 17938: improvement in symptoms and bowel habit in functional constipation

2018 ◽  
Vol 9 (1) ◽  
pp. 51-60 ◽  
Author(s):  
G. Riezzo ◽  
A. Orlando ◽  
B. D’Attoma ◽  
M. Linsalata ◽  
M. Martulli ◽  
...  
Keyword(s):  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Functional Constipation ◽  
Colonic Transit ◽  
Gas Content ◽  
Bowel Habit ◽  
Gut Health ◽  
Double Blind ◽  
Standard Dosage ◽  
Double Blind Clinical Trial

Dysbiosis may contribute to constipation and its symptoms, therefore probiotic administration could improve significantly gut health and functions. The aim of the study was to investigate the effects of a long-lasting administration of Lactobacillus reuteri DSM 17938 (LR DSM 17938) on symptoms and quality of life (QoL) score in patients with functional constipation (FC). 56 FC patients with normal colonic transit time and without anorectal disorders and pelvic floor dysfunctions completed the study. LR DSM 17938 was administered for 105 days in a randomised double-blind clinical trial (28 patients per arm). Individual and cumulative scores including the Constipaq, a modified Constipation Scoring System (CSS) that considers the patient assessment of constipation-QoL (PAC-QoL), were calculated during the preliminary visit (V0), at day 15 (end of the induction period with a LR DSM 17938 double dosage, 4×108 cfu), day 60 (intermediate evaluation) and day 105 (V4) after a standard dosage (2×108 cfu). At the end of treatment, the beneficial effect of LR DSM 17938 compared to placebo was significantly evident for symptoms related to gas content and dysbiosis (abdominal discomfort, pain and bloating), incomplete defecation and helps for defecation (P<0.05). At the end of the whole LR DSM 17938 treatment, a marked and positive effect on both the CSS single and the cumulative items was evident with the exception of unfruitful attempt and Bristol score. Present findings indicate that LR DSM 17938 has an effect on symptoms different from stool consistency, and they suggest that this probiotic can effectively be used in association therapy rather than as single-drug therapy in the management of FC.

scholarly journals Infantile Colic Treated With Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330: A Randomized, Double-Blind, Placebo-Controlled Trial

2021 ◽  
Vol 9 ◽  
Author(s):  
Ke Chen ◽  
Changqi Liu ◽  
Hua Li ◽  
Yuehua Lei ◽  
Chenggui Zeng ◽  
...  
Keyword(s):  
Oral Administration ◽  
Controlled Trial ◽  
Bifidobacterium Longum ◽  
Intervention Group ◽  
Infantile Colic ◽  
Double Blind ◽  
Pediococcus Pentosaceus ◽  
Double Blind Placebo ◽  
Colony Forming Units

Background: Colic is a common condition in infants &lt;4 months of age. Attempts to treat infantile colic with probiotics have shown variable efficacy and overall low evidence of success. In this work, we tested the hypothesis that oral administration of Bifidobacterium longum CECT7894 (KABP042) and Pediococcus pentosaceus CECT8330 (KABP041) mix (1 × 109 colony forming units) would improve the symptoms of infantile colic.Methods: A total of 112 exclusively breastfed or mixed fed infants aged &lt;2 months and meeting the ROME IV criteria for infantile colic were recruited. The infants were randomized in a double-blind, placebo-controlled trial to receive orally administered probiotics (intervention group, IG, n = 48) or placebo (placebo group, PG, n = 42) daily for 21 days.Results: Infants in the IG had significantly shorter crying time (p &lt; 0.001) on day 7 [IG vs. PG, median (25−75th percentile): 38 (3.5–40.5) vs. 62 (40–108) min/day], day 14 [IG vs. PG: 20 (0–40) vs. 50 (30–75) min/day], and day 21 [IG vs. PG: 14 (0–33) vs. 40 (28–62) min/day]. Higher responder ratio and fewer crying/fussing episodes on days 7, 14, and 21 and better stool consistency on day 21 were observed in the IG (p &lt; 0.01) as compared to the PG. Conversely, no significant effects on stool frequency or quality of life were observed.Conclusions: In summary, daily oral administration of B. longum CECT7894 (KABP042) and P. pentosaceus CECT8330 (KABP041) was an effective treatment for shortening crying time due to infantile colic and for improving fecal consistency. This trial was registered retrospectively in December 2019 with a trial number of ISRCTN92431452.

A randomised, double blind, placebo-controlled trial of a fixed dose of N-acetyl cysteine in children with autistic disorder

2016 ◽  
Vol 51 (3) ◽  
pp. 241-249 ◽  
Author(s):  
Olivia M Dean ◽  
Kylie M Gray ◽  
Kristi-Ann Villagonzalo ◽  
Seetal Dodd ◽  
Mohammadreza Mohebbi ◽  
...  
Keyword(s):  
Outcome Measures ◽  
Autistic Disorder ◽  
Controlled Trial ◽  
Demographic Data ◽  
Fixed Dose ◽  
Social Responsiveness ◽  
Vineland Adaptive Behavior Scales ◽  
Double Blind ◽  
Significant Difference ◽  
Acetyl Cysteine

Objective: Oxidative stress, inflammation and heavy metals have been implicated in the aetiology of autistic disorder. N-acetyl cysteine has been shown to modulate these pathways, providing a rationale to trial N-acetyl cysteine for autistic disorder. There are now two published pilot studies suggesting efficacy, particularly in symptoms of irritability. This study aimed to explore if N-acetyl cysteine is a useful treatment for autistic disorder. Method: This was a placebo-controlled, randomised clinical trial of 500 mg/day oral N-acetyl cysteine over 6 months, in addition to treatment as usual, in children with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision diagnosis of autistic disorder. The study was conducted in Victoria, Australia. The primary outcome measures were the Social Responsiveness Scale, Children’s Communication Checklist–Second Edition and the Repetitive Behavior Scale–Revised. Additionally, demographic data, the parent-completed Vineland Adaptive Behavior Scales, Social Communication Questionnaire and clinician-administered Autism Diagnostic Observation Schedule were completed. Results: A total of 102 children were randomised into the study, and 98 (79 male, 19 female; age range: 3.1–9.9 years) attended the baseline appointment with their parent/guardian, forming the Intention to Treat sample. There were no differences between N-acetyl cysteine and placebo-treated groups on any of the outcome measures for either primary or secondary endpoints. There was no significant difference in the number and severity of adverse events between groups. Conclusion: This study failed to demonstrate any benefit of adjunctive N-acetyl cysteine in treating autistic disorder. While this may reflect a true null result, methodological issues particularly the lower dose utilised in this study may be confounders.

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