scholarly journals Absence of Efficacy Of Nonviable Lactobacillus acidophilus for the Prevention of Traveler's Diarrhea: A Randomized, Double-Blind, Controlled Study

2006 ◽  
Vol 43 (9) ◽  
pp. 1170-1175 ◽  
Author(s):  
V. Briand ◽  
P. Buffet ◽  
S. Genty ◽  
K. Lacombe ◽  
N. Godineau ◽  
...  
1991 ◽  
Vol 69 (19) ◽  
pp. 863-866 ◽  
Author(s):  
R. Raedsch ◽  
I. Walter-Sack ◽  
P. R. Galle ◽  
B. Kommerell

1992 ◽  
Vol 36 (1) ◽  
pp. 87-91 ◽  
Author(s):  
H L DuPont ◽  
C D Ericsson ◽  
J J Mathewson ◽  
M W DuPont

2018 ◽  
Vol 9 (5) ◽  
pp. 697-706 ◽  
Author(s):  
K. Preston ◽  
R. Krumian ◽  
J. Hattner ◽  
D. de Montigny ◽  
M. Stewart ◽  
...  

A combination of Lactobacillus acidophilus CL1285, Lactobacillus casei LBC80R and Lactobacillus rhamnosus CLR2 was compared to placebo for relief of symptoms of irritable bowel syndrome (IBS). A total of 113 subjects at 3 clinical sites were randomised in a 2:1 ratio and followed for 12 weeks. Subjects ingested either 2 capsules of active study product, containing 50×109 cfu of live organisms, or 2 placebo capsules daily. Endpoints included improvement in abdominal pain, days of pain, distention, stool consistency and frequency, quality of life (QOL), and adequate relief (AR) of IBS symptoms. IBS subtypes constipation (IBS-C), diarrhoea (IBS-D), and mixed (IBS-M) were evaluated separately; the effect of gender was also examined. For all efficacy endpoints improvement of 30% or more vs placebo was considered clinically significant. With the exception of pain intensity and AR, the endpoints demonstrated a therapeutic advantage of active over placebo for IBS symptoms in at least some subject subgroups. The IBS-D and female subgroups showed the largest and most consistent effects. Stool frequency and consistency were evaluated in the IBS-C and IBS-D subgroups, and improvement of active vs placebo was noted in both. QOL improvement was seen overall and in specific domains. Adverse events (AEs) were limited to 7 subjects; all were of mild or moderate intensity except one, severe cramping. Four AEs in the same subject in the placebo group were judged to be related to study product; these resolved by the end of study. There were no serious AEs.


2001 ◽  
Vol 33 (11) ◽  
pp. 1807-1815 ◽  
Author(s):  
Herbert L. DuPont ◽  
Zhi‐Dong Jiang ◽  
Charles D. Ericsson ◽  
Javier A. Adachi ◽  
John J. Mathewson ◽  
...  

BMJ Open ◽  
2019 ◽  
Vol 9 (11) ◽  
pp. e032617 ◽  
Author(s):  
Janina Marißen ◽  
Annette Haiß ◽  
Claudius Meyer ◽  
Thea Van Rossum ◽  
Lisa Marie Bünte ◽  
...  

IntroductionThe healthy ‘eubiosis’ microbiome in infancy is regarded as the microbiome derived from term, vaginally delivered, antibiotic free, breastfed infants at 4–6 months. Dysbiosis is regarded as a deviation from a healthy state with reduced microbial diversity and deficient capacity to control drug-resistant organisms. Preterm infants are highly sensitive to early gut dysbiosis. Latter has been associated with sepsis and necrotising enterocolitis, but may also contribute to long-term health problems. Probiotics hold promise to reduce the risk for adverse short-term outcomes but the evidence from clinical trials remains inconclusive and none has directly assessed the effects of probiotics on the microbiome at high resolution.Methods and analysisA randomised, double blind, placebo-controlled study has been designed to assess the safety and efficacy of the probiotic mix of Bifidobacterium longum and infantis and Lactobacillus acidophilus in the prevention of gut dysbiosis in preterm infants between 28+0 and 32+6 weeks of gestation. The study is conducted in 18 German neonatal intensive care units. Between April 2018 and March 2020, 654 preterm infants of 28+0–32+6 weeks of gestation will be randomised in the first 48 hours of life to 28 days of once daily treatment with either probiotics or placebo. The efficacy endpoint is the prevention of gut dysbiosis at day 30 of life. A compound definition of gut dysbosis is used: (1) colonisation with multidrug-resistant organisms or gram-negative bacteria with high epidemic potential or (2) a significant deviation of the gut microbiota composition as compared with healthy term infants. Dysbiosis is determined by (1) conventional microbiological culture and (2) phylogenetic microbiome analysis by high-throughput 16S rRNA and metagenome sequencing. Persistence of dysbiosis will be assessed at 12-month follow-up visits. Side effects and adverse events related to the intervention will be recorded. Key secondary endpoint(s) are putative consequences of dysbiosis. A subgroup of infants will be thoroughly phenotyped for immune parameters using chipcytometry.Ethics and disseminationEthics approval was obtained in all participating sites. Results of the trial will be published in peer-review journals, at scientific meetings, on the website (www.primal-study.de) and via social media of parent organisations.Trial registration numberDRKS00013197; Pre-results.


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