Preventive effects of oral probiotic on infantile colic: a prospective, randomised, blinded, controlled trial using Lactobacillus reuteri DSM 17938

2015 ◽  
Vol 6 (3) ◽  
pp. 245-251 ◽  
Author(s):  
F. Savino ◽  
S. Ceratto ◽  
E. Poggi ◽  
M.E. Cartosio ◽  
L. Cordero di Montezemolo ◽  
...  
Keyword(s):  
Infant Formula ◽  
Vitamin D3 ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Protective Action ◽  
Control Group ◽  
Infantile Colic ◽  
North West ◽  
Primary Endpoints ◽  
Cimetropium Bromide

Infants were recruited in four centres in North-West Italy. 138 infants were assessed for eligibility, 113 ones underwent randomisation and 105 completed the study. Newborns aged less than 10 days of life, with gestational age between 37 and 42 weeks, birth weight from 2,500 to 4,300 g and normal physical examination were recruitable. Premature infants and infants affected by outcomes of perinatal hypoxia or necrotising enterocolitis have been excluded. Patients were randomly assigned to receive five drops containing Lactobacillus reuteri DSM 17938 (108 cfu) with 400 UI of vitamin D3 or only 400 UI of vitamin D3 daily. The primary endpoints concern the administration of pain relieving agents (cimetropium bromide at least three times per week or simethicone at least five times per week) from baseline to 12 weeks. Additional analyses were done on the percentage of infants that switched from an exclusive breastfeeding to a partial or exclusive formula feeding from baseline to 12 weeks. Data concerning the number of calls to the paediatricians and the number of visits at paediatricians’ ambulatories due to infantile colic have been collected by paediatrician and analysed. Comparing the two groups, the relative risk was 0.04 (95% confidence interval (CI)=0.01-0.31) for cimetropium bromide, 0.24 (95% CI=0.14-0.41) for simethicone and 0.37 (95% CI=0.17-0.80) for the administration of infant formula, showing a protective action of L. reuteri. The treatment group showed a lower number of paediatric consultations related to episodes of infant colic than the control group (P<0.0001). L. reuteri DSM 17938 supplementation at the tested dosage could reduce parental discomfort due to infantile colic. The consumption of this probiotic is associated with a reduction of paediatric consultations for infantile colic, as well as use of pain relieving agents and of infant formula.

scholarly journals Randomized, controlled trial of lasmiditan over four migraine attacks: Findings from the CENTURION study

Cephalalgia ◽  
2021 ◽  
Vol 41 (3) ◽  
pp. 294-304 ◽  
Author(s):  
Messoud Ashina ◽  
Uwe Reuter ◽  
Timothy Smith ◽  
Judith Krikke-Workel ◽  
Suzanne R Klise ◽  
...  
Keyword(s):  
Controlled Trial ◽  
Study Drug ◽  
Statistical Testing ◽  
Control Group ◽  
Double Blind ◽  
Treatment Groups ◽  
Primary Endpoints ◽  
Registration Number ◽  
Secondary Endpoints ◽  
Common Teaes

Background We present findings from the multicenter, double-blind Phase 3 study, CENTURION. This study was designed to assess the efficacy of and consistency of response to lasmiditan in the acute treatment of migraine across four attacks. Methods Patients were randomized 1:1:1 to one of three treatment groups – lasmiditan 200 mg; lasmiditan 100 mg; or a control group that received placebo for three attacks and lasmiditan 50 mg for either the third or fourth attack. The primary endpoints were pain freedom at 2 h (first attack) and pain freedom at 2 h in ≥2/3 attacks. Secondary endpoints included pain relief, sustained pain freedom and disability freedom. Statistical testing used a logistic regression model and graphical methodology to control for multiplicity. Results Overall, 1471 patients treated ≥1 migraine attack with the study drug. Both primary endpoints were met for lasmiditan 100 mg and 200 mg ( p < 0.001). All gated secondary endpoints were met. The incidence of treatment-emergent adverse events (TEAEs) was highest during the first attack. The most common TEAEs with lasmiditan were dizziness, paresthesia, fatigue, and nausea; these were generally mild or moderate in severity. Conclusions These results confirm the early and sustained efficacy of lasmiditan 100 mg and 200 mg and demonstrate consistency of response across multiple attacks. Trial Registration Number: NCT03670810

scholarly journals Gastrointestinal Tolerance, Growth and Safety of a Partly Fermented Formula with Specific Prebiotics in Healthy Infants: A Double-Blind, Randomized, Controlled Trial

Nutrients ◽  
2019 ◽  
Vol 11 (7) ◽  
pp. 1530 ◽  
Author(s):  
Alfonso Rodriguez-Herrera ◽  
Kelly Mulder ◽  
Hetty Bouritius ◽  
Rocio Rubio ◽  
Antonio Muñoz ◽  
...  
Keyword(s):  
Infant Formula ◽  
Reference Group ◽  
Controlled Trial ◽  
Gastrointestinal Symptoms ◽  
Daily Weight Gain ◽  
Control Group ◽  
Double Blind ◽  
Control Infant ◽  
Breastfed Infants ◽  
Experimental Versus

This study evaluated the effect of a partly fermented infant formula (using the bacterial strains Bifidobacterium breve C50 and Streptococcus thermophilus 065) with a specific prebiotic mixture (short-chain galacto-oligosaccharides (scGOS) and long-chain fructo-oligosaccharides (lcFOS; 9:1)) on the incidence of gastrointestinal symptoms, stool characteristics, sleeping and crying behaviour, growth adequacy and safety. Two-hundred infants ≤28 days of age were assigned either to experimental infant formula containing 30% fermented formula and 0.8 g/100 mL scGOS/lcFOS or to non-fermented control infant formula without scGOS/lcFOS. A group of breastfed infants served as a reference. No relevant differences in parent-reported gastrointestinal symptoms were observed. Stool consistency was softer in the experimental versus control group with values closer to the breastfed reference group. Daily weight gain was equivalent for both formula groups (0.5 SD margins) with growth outcomes close to breastfed infants. No clinically relevant differences in adverse events were observed, apart from a lower investigator-reported prevalence of infantile colic in the experimental versus control group (1.1% vs. 8.7%; p < 0.02). Both study formulae are well-tolerated, support an adequate infant growth and are safe for use in healthy term infants. Compared to the control formula, the partly fermented formula with prebiotics induces stool consistencies closer to breastfed infants.

scholarly journals Lactobacillus Reuteri DSM 17938 in Infantile Colic: A Systematic Review and Meta-Analysis

2022 ◽  
Vol 6 (3) ◽  
pp. 1446-1454
Author(s):  
Burhannudin Ichsan ◽  
Nining Lestari ◽  
Sulistyani
Keyword(s):  
Systematic Review ◽  
Lactobacillus Reuteri ◽  
Controlled Trial ◽  
Meta Analysis ◽  
Forest Plot ◽  
Infantile Colic ◽  
Eligibility Criteria ◽  
Randomized Controlled ◽  
Infant Colic ◽  
Systematic Synthesis

Background. Infantile colic, defined as paroxysmal, excessive, and consolable crying without an identifiable cause. It is common in the first 3 months of life. There have been many RCT studies conducted. A systematic synthesis is required to summarize the results of these RCTs. This study was aimed to systematically analyze the benefits of Lactobacillus reuteri DSM 17938 for infantile colic. Methods. This systematic review and meta-analysis used keywords: (“infantile colic” OR “abdominal cramps” OR “abdominal cramp” OR “infant colic”) AND “lactobacillus reuteri” AND (placebo OR placebos) AND (“randomized controlled trial” OR RCT). The databases used were: pubmed, science direct, and google scholar. Meta-analysis was conducted to combine the articles. The eligibility criteria were: patient with infantile colic, intervention with L. reuteri DSM 17938, control was placebo, RCT study design, outcome with dichotomous scale, all races, all ethnicities, all countries, all genders, in English, and not limited by year. Results. The search resulted in 800 articles. After reducing duplication, the number of articles was 747. Screening with titles and abstracts resulted in 13 full teks articles. Six articles fitted the eligibility criteria. The results of the meta-analysis were as follows. The forest plot showed that the combined effect of the six articles showed an RR of 0.47 and was statistically significant (p <0.001). Conclusion. Based on the results of this meta-analysis, L. reuteri DSM 17938 is recommended for infants with infantile colic. There were no significant side effects with the use of L. reuteri DSM 17938 on infantile colic.

scholarly journals A Mediterranean-like dietary pattern with vitamin D3 (10 µg/d) supplements reduced the rate of bone loss in older Europeans with osteoporosis at baseline: results of a 1-y randomized controlled trial

2018 ◽  
Vol 108 (3) ◽  
pp. 633-640 ◽  
Author(s):  
Amy Jennings ◽  
Kevin D Cashman ◽  
Rachel Gillings ◽  
Aedin Cassidy ◽  
Jonathan Tang ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Femoral Neck ◽  
Vitamin D3 ◽  
Dietary Pattern ◽  
Controlled Trial ◽  
Whole Body ◽  
Control Group ◽  
Site Specific ◽  
Randomized Controlled ◽  
The Mediterranean

ABSTRACT Background The Mediterranean diet (MD) is widely recommended for the prevention of chronic disease, but evidence for a beneficial effect on bone health is lacking. Objective The aim of this study was to examine the effect of a Mediterranean-like dietary pattern [NU-AGE (New Dietary Strategies Addressing the Specific Needs of the Elderly Population for Healthy Aging in Europe)] on indexes of inflammation with a number of secondary endpoints, including bone mineral density (BMD) and biomarkers of bone and collagen degradation in a 1-y multicenter randomized controlled trial (RCT; NU-AGE) in elderly Europeans. Design An RCT was undertaken across 5 European centers. Subjects in the intervention group consumed the NU-AGE diet for 1 y by receiving individually tailored dietary advice, coupled with supplies of foods including whole-grain pasta, olive oil, and a vitamin D3 supplement (10 µg/d). Participants in the control group were provided with leaflets on healthy eating available in their country. Results A total of 1294 participants (mean ± SD age: 70.9 ±4.0 y; 44% male) were recruited to the study and 1142 completed the 1-y trial. The Mediterranean-like dietary pattern had no effect on BMD (site-specific or whole-body); the inclusion of compliance to the intervention in the statistical model did not change the findings. There was also no effect of the intervention on the urinary biomarkers free pyridinoline or free deoxypyridinoline. Serum 25-hydroxyvitamin D significantly increased and parathyroid hormone decreased (P < 0.001) in the MD compared with the control group. Subgroup analysis of individuals with osteoporosis at baseline (site-specific BMD T-score ≤ −2.5 SDs) showed that the MD attenuated the expected decline in femoral neck BMD (n = 24 and 30 in MD and control groups, respectively; P = 0.04) but had no effect on lumbar spine or whole-body BMD. Conclusions A 1-y intervention of the Mediterranean-like diet together with vitamin D3 supplements (10 µg/d) had no effect on BMD in the normal age-related range, but it significantly reduced the rate of loss of bone at the femoral neck in individuals with osteoporosis. The NU-AGE trial is registered at clinicaltrials.gov as NCT01754012.

scholarly journals Tolerance and safety of Lactobacillus paracasei ssp. paracasei in combination with Bifidobacterium animalis ssp. lactis in a prebiotic-containing infant formula: a randomised controlled trial

2009 ◽  
Vol 102 (6) ◽  
pp. 869-875 ◽  
Author(s):  
Arine M. Vlieger ◽  
Afke Robroch ◽  
Stef van Buuren ◽  
Jeroen Kiers ◽  
Ger Rijkers ◽  
...  
Keyword(s):  
Infant Formula ◽  
Controlled Trial ◽  
Normal Growth ◽  
Antibiotic Use ◽  
Early Infancy ◽  
Lactobacillus Paracasei ◽  
Control Group ◽  
Bifidobacterium Animalis ◽  
Probiotic Strains ◽  
Randomised Controlled

The addition of probiotics to infant formula has been shown to be an efficient way to increase the number of beneficial bacteria in the intestine in order to promote a gut flora resembling that of breast-fed infants. The objective of the present study was to evaluate the safety and tolerance of a combination of two probiotic strains in early infancy. A group of 126 newborns were randomised to receive a prebiotic-containing starter formula supplemented with Lactobacillus paracasei ssp. paracasei and Bifidobacterium animalis ssp. lactis or the same formula without probiotics for the first 3 months of life. A total of eighty infants continued the study until they were aged 6 months. Growth measurements were taken monthly at healthy baby clinics. Diaries were used to monitor behaviour, infections, use of antibiotics, as well as stool characteristics. Normal growth occurred in all infants and no statistically significant differences were detected between the probiotics group and the control group for gain in weight, length and head circumference. Infants in the probiotics group produced softer and more frequent stools during the first 3 months of life. No differences were found in crying and sleeping hours, number of parent-diagnosed infections, antibiotic use, visits to the general practitioner and number of adverse events. The use of a prebiotic-containing starter formula supplemented with L. paracasei ssp. paracasei and B. animalis ssp. lactis in early infancy is safe, well tolerated and has no adverse effects on growth and infant behaviour.

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.

scholarly journals Role of Lactobacillus rhamnosus (FloraActive™) 19070-2 and Lactobacillus reuteri (FloraActive™) 12246 in Infant Colic: A Randomized Dietary Study

Nutrients ◽  
2018 ◽  
Vol 10 (12) ◽  
pp. 1975 ◽  
Author(s):  
Sergei Gerasimov ◽  
Jesper Gantzel ◽  
Nataliia Dementieva ◽  
Olha Schevchenko ◽  
Orisia Tsitsura ◽  
...  
Keyword(s):  
Vitamin D3 ◽  
Lactobacillus Reuteri ◽  
Lactobacillus Rhamnosus ◽  
Control Group ◽  
Infant Cry ◽  
Breastfed Infants ◽  
Infant Colic ◽  
Dietary Study ◽  
And Control

Infant colic is a common condition of unknown pathogenesis that brings frustration to families seeking for effective management. Accumulating evidence suggests that some single strains of lactobacilli may play a positive dietary role in attenuation of colic in exclusively breastfed infants. The objective of this study was to evaluate a mixture of two Lactobacillus strains in decreasing infant cry and fuss in this population. Infants aged 4–12 weeks received L. rhamnosus 19070-2 and L. reuteri 12246 in a daily dose of 250 × 106 CFU, 3.33 mg of fructooligosaccharide, and 200 IU of vitamin D3 (84 infants, probiotic group) or just vitamin D3 (84 infants, control group) for 28 days. Cry and fuss time were measured with validated Baby’s Day Diary on days 0 and 28. At baseline, mean (SD) duration of cry and fuss time was comparable in the probiotic and control groups: 305 (81) vs. 315 (90) min., respectively (p = 0.450). On day 28, mean cry and fuss time became statistically different: 142 (89) vs. 199 (72), respectively (p < 0.05). Mean change in cry and fuss time from day 0 through day 28 was −163 (99) minutes in the probiotic and −116 (94) minutes in the control group (p = 0.019). Our findings confirm that lactobacilli decrease cry and fuss time and provide a dietary support in exclusively breastfed infants with colic.

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