Background: Infant colic (IC) is a prevalent physiological event of infants, which can disrupt the child's home environment. We aimed to investigate the effectiveness of a mixture of Matricariae chamomilla L., Melissa officinalis L. and tyndallized Lactobacillus acidophilus (HA122) compared with Lactobacillus reuteri DSM 17938 and with simethicone for the treatment of IC.
Methods:A multicenter randomized comparative study was conducted in infants with colic, according to Rome III criteria, who were randomly assigned to receive M. chamomilla L., M. officinalis L. and tyndallized L. acidophilus (HA122) (Colimil ® Plus ® ; Milte Italia Spa, Milan, Italy) (Group A), L. reuteri DSM 17938 (Group B) and simethicone (Group C). Treatment was given to subjects for 28 days.Key Results: One-hundred and seventy-six patients completed the study. Mean daily crying time at day 28 was significantly lower in group A (−44, 95% CI: −58 to −30, P<.001) and group B (−35, 95% CI: −49 to −20, P<.001) when compared to group C.No significant difference was observed between Group A and Group B (mean difference: −9 minutes, 95% CI −23 to +5, P=.205). At day 28, 39 of 57 (68.4%) of infants in Group C responded to the treatment compared with 57 out of 60 patients (95%) of Group A and 51 out of 59 (86.4%) of Group B (P<.001).
Conclusions:This study suggests that administration of M. chamomilla L., M. officinalis L. and tyndallized L. acidophilus (HA122) and L. reuteri DSM 17938 are significantly more effective than simethicone in IC. Clinical Trial Registration: ClinicalTrials.gov: NCT02708238.
K E Y W O R D Scomplementary and alternative medicine, herbal supplement, infantile colic, probiotics
BackgroundAbout 30% of constipated children continue to struggle with constipation beyond puberty. Growing interest has recently raised on the use of probiotics as complementary therapy for FC, in order to prevent the possible PEG-related intestinal dysbiosis. Our study aimed at evaluating the effect on childhood FC of a probiotic mixture (PM), including Bifidobacteria breve M-16 V®, infantis M-63®, and longum BB536®.MethodsFifty-five consecutive children suffering from FC were randomly assigned into two groups: group A received a daily oral combination of PEG plus PM and group B received oral PEG only. Physical and clinical data were collected from each patient at week-1, week-2, week-4, and week-8.ResultsAfter 1 month, children who experienced improvement in the PEG and in the PEG + PM group were 88 and 81.8%, respectively (p = 0.24). After 1 month from the end of the study treatment, a positive trend towards a higher rate of clinical remission was observed within children treated with PM compared to those who took only PEG (percentage of children off therapy: 64 vs 52, respectively; p = 0.28).ConclusionsPEG and PEG + PM are equally effective and safe in the treatment of children with chronic constipation. Nevertheless, further studies are needed to show if adding Bifidobacteria strains to conventional therapy may lead to a better long-term outcome.
Background
Vaccine-preventable diseases and opportunistic infections in pediatric inflammatory bowel disease (IBD) are increasingly recognized issues. The aims of this study were to evaluate vaccinations, immunization status, and consequent therapeutic management in children with IBD and to analyze the differences among patients diagnosed before (Group 1) and after June 2012 (Group 2).
Methods
This was a multicenter, retrospective cohort investigation. Between July 2016 and July 2017, 430 children with IBD were enrolled in 13 centers. Diagnosis, therapeutic history, vaccinations, and immunization status screening at diagnosis and at immunosuppressant (IM)/biologic initiation and reasons for incomplete immunization were retrieved.
Results
Vaccination rates at diagnosis were unsatisfactory for measles, mumps, and rubella (89.3%), Haemophilus influenzae (81.9%), meningococcus C (23.5%), chickenpox (18.4%), pneumococcus (18.6%), papillomavirus (5.9%), and rotavirus (1.9%). Complete immunization was recorded in 38/430 (8.8%) children, but specific vaccines were recommended in 79/430 patients (18.6%), without differences between the 2 groups. At IM start, 22% of children were tested for Epstein-Barr virus (EBV) status, with 96.2% of EBV-naïve patients starting azathioprine, without differences between Groups 1 and 2. Screening for latent tuberculosis (TB) before start of biologics was performed in 175/190 (92.1%), with up to 9 different screening strategies and numerous inconsistencies.
Conclusions
We demonstrated a poor immunization status at diagnosis in children with IBD, which was not followed by proper vaccination catch-up. EBV status before IM initiation and latent TB before biologics were not adequately assessed. Thus, the overall impact of the current guidelines seems unsatisfactory.
Inflammation inversely correlates to VDBP concentrations and patients with IBD, despite their deficiency in total 25(OH)D, have normal or even higher levels of free 25(OH)D.
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