Safety and acceptability of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 in Bangladeshi infants: a phase I randomized clinical trial
نویسندگان
چکیده
BACKGROUND Probiotics have rarely been studied in young healthy infants from low-income countries. This phase I study investigated the safety and acceptability of two probiotics in Bangladesh. METHODS Healthy infants aged four to twelve weeks from urban slums in Bangladesh were randomized to one of three different intervention dosing arms (daily, weekly, biweekly - once every two weeks) of Lactobacillus reuteri DSM 17938 and Bifidobacterium longum subspecies infantis 35624 over one month or to a fourth arm that received no probiotics. All subjects were followed for two additional months. Reported gastrointestinal and respiratory symptoms as well as breastfeeding rates, hospitalizations, differential withdrawals, and caretakers' perception of probiotic use were compared among arms. RESULTS In total, 160 infants were randomized (40 to each arm) with 137 (Daily n = 35, Weekly n = 35, Biweekly n = 35, Control n = 32) followed up for a median of twelve weeks; 113 completed the study. Illness and breastfeeding rates were similar across all arms. Ten hospitalizations unrelated to probiotic use occurred. Forty eight percent of the caretakers of infants in intervention arms believed that probiotics improved their baby's health. CONCLUSIONS These two commonly used probiotics appeared safe and well-accepted by Bangladeshi families. TRIAL REGISTRATION ClinicalTrials.gov NCT01899378 . Registered July 10, 2013.
منابع مشابه
970Safety of Bifidobacterium longum infantis and Lactobacillus reuteri in Bangladeshi Infants
Bangladeshi Infants Yana Emmy Hoy-Schulz, PhD; Kaniz Jannat, MBBS; Thomas Roberts, BS; Mostafizur Rahman, MD; Saira Zaidi, BS; Leanne Unicomb, PhD; Stephen Luby, MD; Julie Parsonnet, MD; Stanford University School of Medicine, Stanford, CA; Center for Communicable Diseases, International Center for Diarrheal Disease Research, Bangladesh, Dhaka, Bangladesh; University of California, Berkeley Sch...
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Effects of Probiotic Lactobacillus Reuteri (DSM 17938) on the Incidence of Necrotizing Enterocolitis in Very Low Birth Weight Premature Infants
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متن کاملSafety and tolerability of Bifidobacterium longum subspecies infantis EVC001 supplementation in healthy term breastfed infants: a phase I clinical trial
BACKGROUND Historically, bifidobacteria were the dominant intestinal bacteria in breastfed infants. Still abundant in infants in developing nations, levels of intestinal bifidobacteria are low among infants in developed nations. Recent studies have described an intimate relationship between human milk and a specific subspecies of Bifidobacterium, B. longum subsp. infantis (B. infantis), yet sup...
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Background: Prophylactic efficacy against colitis following lactobacillus consumption in interleukin 10 (IL-10) knockout (KO) mice has been reported. Whether this applies equally to other probiotic strains is unknown, and the mechanism is unclear. Aims: (1) To compare the effect of feeding Lactobacillus salivarius subspecies salivarius 433118 and Bifidobacterium infantis 35624 against placebo o...
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عنوان ژورنال:
دوره 16 شماره
صفحات -
تاریخ انتشار 2015