Bacillus clausii UBBC-07 reduces severity of diarrhoea in children under 5 years of age: a double blind placebo controlled study

2019 ◽  
Vol 10 (2) ◽  
pp. 149-154 ◽  
Author(s):  
M. Ratna Sudha ◽  
N. Jayanthi ◽  
D.C. Pandey ◽  
A.K. Verma
Keyword(s):  
Placebo Group ◽  
Acute Diarrhoea ◽  
Treated Group ◽  
Controlled Study ◽  
Duration Of Treatment ◽  
Double Blind ◽  
Safe Alternative ◽  
Multicentric Study ◽  
Oral Rehydration ◽  
Bacillus Clausii

Acute diarrhoea is one of the leading causes of mortality in infants and young children. Evidence suggests that probiotics can reduce diarrhoea duration. As the effects of probiotics are strain specific, the effect of Bacillus clausii UBBC-07, a safe probiotic strain in the treatment of acute diarrhoea in children was studied. The double blind, randomised, placebo-controlled, parallel group multicentric study was conducted at two outpatient facility sites in Lucknow, India. Children aged six months to five years suffering from acute diarrhoea, were randomly assigned to receive either probiotic (B. clausii UBBC-07) spore suspension or placebo suspension twice daily apart from oral rehydration solution (ORS). The duration of treatment was for five days with a follow -up until the 10th day. Outcomes evaluated were duration and frequency of diarrhoea, consistency of stool, fever and vomiting. The duration of diarrhoea was significantly shorter (P<0.05) in patients who received B. clausii suspension (75.66±13.23 h) than in placebo treated group (81.6±15.43 h). The average daily number of stools (frequency) was 8.67±3.42 at baseline in treatment group receiving B. clausii and 8.53±3.19 in placebo group. By day 4, there was a significant reduction (P<0.01) in frequency of stools in probiotic treated group (3.46±0.66) as compared to placebo group (4.57±1.59). Improvement in stool consistency was also observed in the probiotic treated group as compared to the placebo group. There was no effect on vomiting and duration of fever. B. clausii UBBC-07 significantly decreased the duration and frequency of diarrhoea as compared to placebo indicating effectiveness of strain in the treatment of acute diarrhoea in children and could be a safe alternative to antibiotics.

scholarly journals Efficacy of an Oral Rehydration Solution Enriched with Lactobacillus reuteri DSM 17938 and Zinc in the Management of Acute Diarrhoea in Infants: A Randomized, Double-Blind, Placebo-Controlled Trial

Nutrients ◽  
2018 ◽  
Vol 10 (9) ◽  
pp. 1189 ◽  
Author(s):  
Maria Maragkoudaki ◽  
George Chouliaras ◽  
Antonia Moutafi ◽  
Athanasios Thomas ◽  
Archodoula Orfanakou ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Lactobacillus Reuteri ◽  
Oral Rehydration Solution ◽  
Statistical Significance ◽  
Acute Diarrhoea ◽  
Controlled Study ◽  
Double Blind ◽  
Oral Rehydration ◽  
Number Of Patients ◽  
Rehydration Solution

The efficacy of oral rehydration solution (ORS) enriched with Lactobacillus reuteri DSM 17938 and zinc in infants with acute gastroenteritis, is poorly defined. The aim of this double-blind, randomized, placebo-controlled study, was to assess the efficacy of an ORS enriched with Lactobacillus reuteri DSM 17938 and zinc (ORS+Lr&Z) in well-nourished, non-hospitalized infants with acute diarrhoea. Fifty one infants with acute diarrhoea were randomly assigned to receive either ORS+Lr&Z (28 infants, mean ± SD age 1.7 ± 0.7 years, 21 males), or standard ORS (ORS−Lr&Z; 23 infants, mean ± SD age 1.8 ± 0.7 years, 16 males). Stools volume and consistency were recorded pre- and posttreatment using the Amsterdam Infant Stool Scale and were compared between the two groups, as well as lost work/day care days, drug administration and need for hospitalization. Both groups showed reduction in the severity of diarrhoea on day two (p < 0.001) while, all outcomes showed a trend to be better in the ORS+Lr&Z group, without reaching statistical significance, probably due to the relatively small number of patients. No adverse effects were recorded. In conclusion, both ORS were effective in managing acute diarrhoea in well-nourished, non-hospitalized infants. ORS enriched with L. reuteri DSM 17938 and zinc was well tolerated with no adverse effects.

scholarly journals Effect and Tolerability of a Nutritional Supplement Based on a Synergistic Combination of β-Glucans and Selenium- and Zinc-Enriched Saccharomyces cerevisiae (ABB C1®) in Volunteers Receiving the Influenza or the COVID-19 Vaccine: A Randomized, Double-Blind, Placebo-Controlled Study

Nutrients ◽  
2021 ◽  
Vol 13 (12) ◽  
pp. 4347
Author(s):  
Julián Andrés Mateus Rodriguez ◽  
Mónica Bifano ◽  
Elvira Roca Goma ◽  
Carlos Méndez Plasencia ◽  
Anna Olivé Torralba ◽  
...  
Keyword(s):  
Saccharomyces Cerevisiae ◽  
Placebo Group ◽  
Serum Levels ◽  
Nutritional Supplement ◽  
Controlled Study ◽  
Duration Of Treatment ◽  
Serious Adverse Events ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Synergistic Combination

A single-center, randomized, double-blind, placebo-controlled study was conducted in 72 volunteers who received a synergistic combination of yeast-based ingredients with a unique β-1,3/1,6-glucan complex and a consortium of heat-treated probiotic Saccharomyces cerevisiae rich in selenium and zinc (ABB C1®) or placebo on the next day after getting vaccinated against influenza (Chiromas®) (n = 34) or the COVID-19 (Comirnaty®) (n = 38). The duration of treatment was 30 and 35 days for the influenza and COVID-19 vaccine groups, respectively. Mean levels of CD4+T cells increased from 910.7 at baseline to 1000.2 cells/µL after the second dose of the COVID-19 vaccine in the ABB C1® group, whereas there was a decrease from 1055.1 to 929.8 cells/µL in the placebo group. Changes of CD3+T and CD8+T lymphocytes showed a similar trend. In the COVID-19 cohort, the increases in both IgG and IgM were higher in the ABB C1® supplement than in the placebo group. Serum levels of selenium and zinc showed a higher increase in subjects treated with the active product than in those receiving placebo. No serious adverse events related to ABB C1® or tolerance issues were reported. The study findings validate the capacity of the ABB C1® product to stimulate trained immunity.

Homœopathic treatment of acute childhood diarrhoea

1993 ◽  
Vol 82 (02) ◽  
pp. 83-86 ◽  
Author(s):  
Luz Margarita Jiminez ◽  
Steven Gloyd ◽  
Felix Esponiza Carares ◽  
Margarita Paniagua Gaitan ◽  
Dean Crothers ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Placebo Group ◽  
Treated Group ◽  
Aetiological Agent ◽  
Double Blind ◽  
Oral Rehydration ◽  
Childhood Diarrhoea ◽  
Significant Difference ◽  
The Mean ◽  
Larger Sample

AbstractA double-blind, randomized clinical trial to compare homœopathic treatment versus placebo in the treatment of acute childhood diarrhoea was carried out in Leon, Nicaragua, in July 1990. 34 children aged 6 months to 5 years were randomized into active and placebo groups, both of which also received oral rehydration treatment. The mean duration of diarrhoea after treatment in the active group was 2.4 days, compared to 3.0 days in the placebo group, which was not statistically significant. Exploratory analysis revealed a statistically significant decrease (p=0.04) in the subgroup of patients for which an aetiological agent was found. There was also a significant difference in number of stools per day in the treated group (p=0.002) at the end of the treatment period. Since small numbers prevent a definitive conclusion from this study, further study with a larger sample size would seem appropriate.

scholarly journals Effects of GH on cognitive function in elderly patients with adult-onset GH deficiency: a placebo-controlled 12-month study

2007 ◽  
Vol 156 (4) ◽  
pp. 439-447 ◽  
Author(s):  
Mahesh Sathiavageeswaran ◽  
Pia Burman ◽  
David Lawrence ◽  
Alan G Harris ◽  
Marina G Falleti ◽  
...  
Keyword(s):  
Placebo Group ◽  
Cognitive Function ◽  
Elderly Patients ◽  
Gh Deficiency ◽  
Treated Group ◽  
Controlled Study ◽  
Examination System ◽  
Gh Therapy ◽  
Double Blind ◽  
Igf I

Objective: Young adults with childhood-onset GH deficiency (GHD) have reduced memory and attention, which can be improved by treatment with GH. Little information is available on cognitive function in elderly GHD patients. Design: Single center, double-blind, randomized, placebo-controlled study of 52-week duration. Methods: Elderly GH therapy naïve GHD patients (n=34; age range 60–77 years) were enrolled and randomized to receive placebo or GH therapy which was titrated to achieve a target IGF-I level of +1 to +2 s.d. of the normal mean for age. Cognitive function was assessed at baseline and after 24 and 52 weeks, using a computerized psychometric test package (Neurobehavioral Examination System-2). Results: The mean GH dose was 0.16±0.06 mg/day; mean IGF-I increased from 135±59 ng/ml at baseline to 213±77 ng/ml during active treatment. The GH-treated group had better mean serial digit learning scores compared with placebo group (P<0.05). Assessment of effect sizes showed that improvements in memory occurred with GH after 24 weeks. The overall adverse event rates were similar in the GH and the placebo group. Conclusion: This study indicates that GH replacement may be accompanied by improvement in certain measures of cognitive function in elderly patients with GHD.

Effects of Consumption of Probiotic Powder Containing Lactobacillus Plantarum Dad-13 on Fecal Bacterial Population in School-Age Children in Indonesia

2019 ◽  
Vol 14 (1) ◽  
pp. 1-8 ◽  
Author(s):  
Banin Maghfirotin Marta ◽  
Utami Tyas ◽  
Cahyanto Muhammad Nur ◽  
Widada Jaka ◽  
Rahayu Endang Sutriswati
Keyword(s):  
Placebo Group ◽  
Gut Microbiota ◽  
Lactobacillus Plantarum ◽  
Coliform Bacteria ◽  
School Age Children ◽  
Controlled Study ◽  
School Age ◽  
Double Blind ◽  
Probiotic Group ◽  
E Coli

Consumption of probiotics is known to influence the gut microbiota. The aim of this study was to assess the effect of probiotic powder containing Lactobacillus plantarum Dad-13 on bacterial composition in the gut by examining fecal samples of school-age children in Yogyakarta, Indonesia. This is a randomized, double-blind, placebo-controlled study. A total of 40 healthy subjects were recruited for this study and were divided into two groups: placebo group and probiotic group. The placebo group consumed skim milk and the probiotic group consumed probiotic powder containing L. plantarum Dad-13 (2 × 109 CFU/g) for 65 days. The results showed that placebo intake had no significant effect on gut microbiota; however, probiotic caused a significant increase in L. plantarum and Lactobacillus population, while decreasing the population of E. coli and non-E. coli coliform bacteria by 55% and 75%, respectively and Bifidobacteria count did not change significantly. The study concluded that consumption of probiotic powder L. plantarum Dad-13 could increase propionic acid thereby decreasing the gut pH which has an effect on the microbial population.

scholarly journals DL-3-n-butylphthalide improves cerebral hypoperfusion in patients with large cerebral atherosclerotic stenosis. A single-center, randomized, double-blind, placebo-controlled study.

2020 ◽  
Author(s):  
Dawei Chen ◽  
Yanwei Yin ◽  
Jin Shi ◽  
Fen Yang ◽  
Kehua Wang ◽  
...  
Keyword(s):  
Placebo Group ◽  
Single Photon ◽  
Photon Emission ◽  
Cerebral Hypoperfusion ◽  
Controlled Study ◽  
Emission Computed Tomography ◽  
Single Center ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Atherosclerotic Stenosis

Abstract Background: DL-3-n-butylphthalide (NBP) was demonstrated to increase the cerebral blood flow (CBF) in the animal models, but there are no clinic studies to verify this. We aimed to explore the effect of NBP on improving cerebral hypoperfusion caused by cerebral large-vessel stenosis. Methods: In this single-center, randomized, double-blind, placebo-controlled study, 120 patients with severe carotid atherosclerotic stenosis and cerebral hypoperfusion in the ipsilateral middle cerebral artery (MCA) were included and randomly assigned into NBP or placebo group as 1:1 radio. Patients in NBP or placebo group received 200mg or 20mg of NBP capsules three times daily for four weeks respectively. Single photon emission computed tomography (SPECT) was used to assess regional CBF (rCBF) in four regions of interest (ROIs) corresponding to MCA before and 12 weeks after the treatment. After therapy, the rCBF change for every ROI and the whole CBF change in MCA territory for every patient were classified into amelioration, stabilization and deterioration respectively. Results: 48 NBP patients (6 with bilateral stenosis) and 46 placebo patients (8 with bilateral stenosis) completed the trial. Overall, both groups had 54 stenotic carotid arteries and 216 ROIs for rCBF change analysis. After therapy, the rCBF in ROIs increased in NBP group (83.5%±11.4% vs. 85.8%±12.5%, p=0.000), whereas no change was found in placebo group (86.9%±11.6% vs. 87.8%±11.7%, p=0.331). Besides, there was higher percentages of ROIs with rCBF amelioration and stabilization in NBP group than in placebo group (93.1% vs. 79.2%, p=0.000). Furthermore, ordinal regression analysis showed that compared with placebo, NBP independently made more patients to have whole CBF amelioration in ipsilateral MCA (Wald-χ2=5.247, OR=3.31, p=0.022). Conclusions: NBP might improve the cerebral hypoperfusion in the patients with carotid artery atherosclerotic stenosis. Trial registration: Chinese Clinical Trial Registry, ChiCTR1900028005, registered December 8th 2019- Retrospectively registered ( http://www.chictr.org.cn/index.aspx ).

scholarly journals A Randomised Controlled Trial on the Efficacy and Safety of Oral Ketamine in Neonatal Circumcision

2021 ◽  
Author(s):  
Victor Ifeanyichukwu Modekwe ◽  
Jideofor Okechukwu Ugwu ◽  
Okechukwu Hyginus Ekwunife ◽  
Andrew Nwankwo Osuigwe ◽  
Jideofor Chukwuma Orakwe ◽  
...  
Keyword(s):  
Placebo Group ◽  
Controlled Trial ◽  
Controlled Study ◽  
Categorical Variables ◽  
Paediatric Surgery ◽  
Peripheral Oxygen Saturation ◽  
Double Blind ◽  
Oral Ketamine ◽  
The Mean ◽  
Neonatal Circumcision

Introduction: Procedural analgesia use in neonatal circumcision is not widespread in the developing world. An easy-to-administer, adequate and safe analgesia will encourage usage in neonatal circumcision. Orally administered ketamine may prove effective and safe, and may encourage procedural analgesia use in neonatal circumcision. Aim: To determine the analgesic efficacy of oral ketamine in Plastibell® neonatal circumcision. Materials and Methods: A hospital based randomised double blind controlled study was conducted at the paediatric surgery unit of the hospital, from March 2015 to December 2015. Total 121 neonates were sequentially recruited, and randomised into two groups. Group A received oral ketamine, and Group B received plain syrup (placebo) as procedural analgesia. Continuous pulse oximeter monitoring was done before, during and immediately after the procedure. The pre-procedural and intra-procedural peripheral oxygen saturation (SpO2) and Pulse Rate (PR) were determined at the various stages. Also, the Neonatal Infant Pain Scale (NIPS) scores were assessed during the stages of the procedure. Differences in mean scores were analysed. Mann-Whitney U test and Independent t-test were used to compare means of continuous variable, while Fisher’s exact test was used to compare categorical variables. Significance was set at p<0.05. Results: Sixty-one neonates received oral ketamine, while 60 received placebo. The intraoperative mean SpO2 were lower in the placebo group and significant at the tying stage with p=0.022. The mean intraoperative PR was higher in the placebo group and significant at dorsal-slit, tying and excision stages (p<0.05). The mean intraoperative NIPS scores were significantly higher in the placebo group. Conclusion: Oral ketamine provides effective and safe analgesia for neonatal Plastibell® circumcision in comparison to placebo.

Can Simvastatin reduce COPD Exacerbations? A Randomised Double Blind Controlled Study

2021 ◽  
pp. 2001798
Author(s):  
Peter Schenk ◽  
Alexander O. Spiel ◽  
Felix Hüttinger ◽  
Micheline Gmeiner ◽  
Josefine Fugger ◽  
...  
Keyword(s):  
Placebo Group ◽  
Lung Function ◽  
Tertiary Care ◽  
Controlled Study ◽  
Rank Test ◽  
Chronic Obstructive ◽  
Single Center ◽  
Double Blind ◽  
Exacerbation Rate ◽  
Simvastatin Group

Several studies have shown that statins have beneficial effects in chronic obstructive pulmonary disease (COPD) regarding lung function decline, rates and severity of exacerbations, hospitalisation and need for mechanical ventilation.We performed a randomised double-blind placebo-controlled single-center trial of simvastatin at a daily dose of 40 mg versus placebo in patients with Global Initiative for COPD criteria II-IV at a tertiary care pulmonology department in Austria. Scheduled treatment duration was 12 months and main outcome parameter was time to first exacerbation.Overall 209 patients were enrolled. In the 105 patients taking simvastatin, time to first exacerbation was significantly longer compared to the 104 patients taking placebo: median 341 versus 140 days, log-rank test p<0.001. Hazard ratio for risk of first exacerbation for the simvastatin group was 0.51 (95% CI 0.34–0.75; p=0.001). Rate of exacerbations was significantly lower with simvastatin: 103 (41%) versus 147 (59%), p=0.003. The annualised exacerbation rate was 1.45 per patient-year in the simvastatin group and 1.9 in the placebo group (IRR 0.77, 95% CI 0.60 to 0.99).We found no effect on quality of life, lung function, 6-minute walk test and high-sensitivity C-reactive protein. More patients dropped out in the simvastatin group compared to the placebo group (39 versus 29).In our single-center RCT, simvastatin at a dose of 40 mg daily significantly prolonged time to first COPD exacerbation and reduced exacerbation rate.

scholarly journals Rice Bran Supplement Containing A Functional Substance, the Novel Peptide Leu-Arg-Ala, has Anti-Hypertensive Effects: A Double-Blind, Randomized, Placebo-Controlled Study

Nutrients ◽  
2019 ◽  
Vol 11 (4) ◽  
pp. 726
Author(s):  
Ogawa ◽  
Shobako ◽  
Fukuhara ◽  
Satoh ◽  
Kobayashi ◽  
...  
Keyword(s):  
Blood Pressure ◽  
Placebo Group ◽  
Adverse Events ◽  
Rice Bran ◽  
Test Group ◽  
Normal Blood ◽  
Controlled Study ◽  
The Novel ◽  
Normal Blood Pressure ◽  
Double Blind

The anti-hypertensive effect of processed rice bran (PRB) was recently reported, for which the novel peptide Leu-Arg-Ala (LRA) was identified as the functional substance. The purpose of this study was to assess the anti-hypertensive effects of a rice bran supplement containing PRB in individuals with high-normal blood pressure (systolic blood pressure (SBP): 130–139 mmHg and/or diastolic blood pressure (DBP): 85–89 mmHg) or grade 1 hypertension (SBP: 140–159 mmHg and/or DBP: 90–99 mmHg). One hundred individuals with high-normal blood pressure or grade 1 hypertension were recruited to participate in this double-blind, randomized, placebo-controlled study. Participants were randomly allocated to the placebo group (n = 50) or the test group (n = 50). Each group took four test tablets (43 μg LRA/day) or four placebo tablets daily. The decrease in blood pressure in the test group compared with the placebo group was the primary outcome. Adverse events were recorded and hematological/urinary parameters measured to determine the safety of the supplement, which was the secondary outcome. In total, 87 participants completed the study. The SBP of the test group at 12 weeks was significantly lower than that of the placebo group (p = 0.0497). No serious adverse events were observed. Daily consumption of a rice bran supplement containing PRB can safely improve mildly elevated blood pressure.

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