Efficacy of Bifidobacterium breve CECT7263 for infantile colic treatment: an open-label, parallel, randomised, controlled trial.

Infantile colic is a prevalent condition characterised by excessive crying with no effective treatment available. We aimed to evaluate the efficacy of Bifidobacterium breve CECT7263 and a combination of this and Lactobacillus fermentum CECT5716 versus simethicone in reducing the daily time spent crying in colicky infants. A multicentre randomised, open-label, parallel, controlled trial of 28 days was performed in 150 infants who were diagnosed with colic according to the Rome III criteria and who randomly received simethicone (80 mg/day; Simethicone group), B. breve CECT7263 (2×108 cfu/day, Bb group), or a combination of L. fermentum CECT5716 and B. breve CECT7263 (1×108 cfu/day per strain, Bb+Lf group). The main outcomes were minutes of crying per day and the percentage of reduction in daily crying from baseline. Data were analysed per intention to treat. All treatments significantly decreased the daily crying time at the end of the intervention (P-time <0.001). However, the infants in the Bb group had significantly decreased crying time from the first week of the study (P<0.05), whereas the Bb+Lf group and the simethicone group had significantly decreased crying time from the second week (P<0.05). The percentage of reduction in the minutes of crying from baseline in the Bb group was significantly higher than that in the Simethicone group every week of the intervention (-40.3 vs -27.6% at 1-week; -59.2 vs -43.2% at 2-weeks; -64.5 vs -53.5% at 3-week and -68.5 vs -59.5% at 4-weeks, P<0.05). Additionally, in the Bb group, infants had better night sleep, and parents reported a more positive mood at the end of the intervention. All the products used in the study were safe and well tolerated. In conclusion, the breastmilk-isolated probiotic strain B. breve CECT7263 is a safe and effective treatment for infantile colic, presenting an earlier and more robust effect than the reference prescribed drug, simethicone.

Evaluation of Nutritional Biochemical Parameters in Haemodialysis Patients over a Ten-year Period.

AIM: Protein-energy malnutrition as well as systemic inflammation and metabolic disorders are common in patients with chronic kidney failure, who require renal replacement therapy (haemodialysis). Such malnutrition is a factor that significantly contributes to their morbidity and mortality. This study evaluated the nutritional status of haemodialysis patients by assessing biochemical and anthropometric parameters in order to determine whether these patients suffered disorders reflecting nutritional deterioration directly related to time on haemodialysis. SUBJECTS AND METHOD: This research comprised 90 patients of both genders with chronic kidney failure, who regularly received haemodialysis at our unit over a period of ten years. The patients' blood was tested quarterly for plasma albumin, total cholesterol and total proteins, and tested monthly for transferrin. The patients' weight, height and body mass index (BMI) were monitored. Body mass index was calculated using the formula: weight (kg)/height (m2 ) and classified in one of the following categories defined in the World Health Organization (WHO) Global Database on Body Mass Index: (i) underweight [BMI < 18.50], (ii) normal [BMI 18.50 - 24.99], (iii) overweight [BMI 25 - 29.99], (iv) obese [BMI > 30]. RESULTS: In the ten-year period of the study, the patients experienced a substantial decline in their biochemical parameters. Nevertheless, their BMI did not show any significant changes despite the patients' state of malnutrition. CONCLUSIONS: The prevalence of malnutrition in haemodialysis patients was evident. Nevertheless, the BMI of the subjects did not correspond to the biochemical parameters measured. Consequently, the results showed that the nutritional deterioration of these patients was mainly reflected in their biochemical parameters rather than in their anthropometric measurements.