Archive for category Infant & Child Health
J Nutr ’10: Controlled trial evaluating safety of maternal and infant feeding of 4 probiotic strains reports good results
Allen S, Jordan S, Storey M, et al. Dietary supplementation with lactobacilli and bifidobacteria is well tolerated and not associated with adverse events during late pregnancy and early infancy. J Nutr 2010;140(3):483-488.
Lactic acid bacteria and bifidobacteria are increasingly being administered to pregnant women and infants with the intention of improving health. Although these organisms have a long record of safe use, it is important to identify any adverse effects in potentially vulnerable populations.
In a randomized, double-blinded, placebo-controlled trial, we evaluated the safety of a bacterial dietary supplement for the prevention of atopy in infants. Two strains of lactobacilli (Lactobacillus salivarius CUL61 and Lactobacillus paracasei CUL08) and bifidobacteria (Bifidobacterium animalis subsp. lactis CUL34 and Bifidobacterium bifidum CUL20) with a total of 1 × 1010 colony-forming units were administered daily to women during the last month of pregnancy and to infants aged 0–6 mo. Adverse events (AE) were classified according to WHO International Statistical Classification of Diseases criteria. Common symptoms were recorded by regular questionnaires.
Baseline characteristics of 220 mother-infant dyads in the treatment and 234 in the placebo group were similar. Compliance with the trial interventions, loss to follow-up, symptoms, drug usage, infant growth, method of feeding, visits to the doctor, and mothers’ assessment of infant health were similar in the 2 groups. Fifteen (6.8%) mothers and 73 (33.2%) infants in the treatment group and 21 (9.0%) mothers and 75 (32.1%) infants in the placebo group reported AE (P = 0.49 and P = 0.84, respectively). Severe AE occurred in 18 mothers and 63 infants with a similar frequency in each group. None of the AE were attributed to the intervention.
Our findings support the safe use of this consortium of organisms during pregnancy and early infancy.
Br J Derm ’10: Maternal consumption of probiotic blend reduces atopic dermatitis in children at risk for allergies
Dotterud C, Storrø O, Johnsen R, et al. Probiotics in pregnant women to prevent allergic disease: A randomized, double-blind trial. Br J Dermatol 2010;163(3):616-623.
Previous reports have suggested that certain probiotics given to mothers and children at risk of atopy halves the incidence of atopic dermatitis (AD) at 2 years of age.
To examine if probiotics given to pregnant women in a nonselected population could prevent atopic sensitization or allergic diseases during the child’s first 2 years.
In a randomized, double-blind trial of children from a nonselected maternal population (ClinicalTrials.gov identifier: NCT00159523), women received probiotic milk or placebo from 36 weeks of gestation to 3 months postnatally during breastfeeding. The probiotic milk contained Lactobacillus rhamnosus GG, L. acidophilus La-5 and Bifidobacterium animalis subsp. lactis Bb-12. Children with an itchy rash for more than 4 weeks were assessed for AD. At 2 years of age, all children were assessed for atopic sensitization, AD, asthma and allergic rhinoconjunctivitis. The intention-to-treat (ITT) analysis was enabled by multiple imputations.
Four hundred and fifteen pregnant women were computer randomized. At 2 years, 138 and 140 children in the probiotic and the placebo groups, respectively, were assessed. In the ITT analysis, the odds ratio (OR) for the cumulative incidence of AD was 0·51 in the probiotic group compared with the placebo [95% confidence interval (CI) 0·30–0·87; P = 0·013]. There were no significant effects on asthma (OR 0·68, 95% CI 0·26–1·80; P = 0·437) or atopic sensitization (OR 1·52, 95% CI 0·74–3·14; P = 0·254).
Probiotics given to nonselected mothers reduced the cumulative incidence of AD, but had no effect on atopic sensitization.
Ped All Immun ’10: Maternal consumption of probiotic blend reduces eczema in infants at high risk of allergy during the first year of life
Kim J, Kwon J, Ahn S, et al. Effect of probiotic mix (Bifidobacterium bifidum, Bifidobacterium lactis, Lactobacillus acidophilus) in the primary prevention of eczema: A double-blind, randomized, placebo-controlled trial. Pediatr Allergy Immunol 2010;21:e386-e393.
Controversy exists regarding the preventive effect of probiotics on the development of eczema or atopic dermatitis. We investigated whether supplementation of probiotics prevents the development of eczema in infants at high risk.
In a randomized, double-blind, placebo-controlled trial, 112 pregnant women with a family history of allergic diseases received a once-daily supplement, either a mixture of Bifidobacterium bifidum BGN4, B. lactis AD011, and Lactobacillus acidophilus AD031, or placebo, starting at 4–8 wks before delivery and continuing until 6 months after delivery.
Infants were exclusively breast-fed during the first 3 months, and were subsequently fed with breastmilk or cow’s milk formula from 4 to 6 months of age.
Clinical symptoms of the infants were monitored until 1 yr of age, when the total and specific IgE against common food allergens were measured. A total of 68 infants completed the study.
The prevalence of eczema at 1 yr in the probiotic group was significantly lower than in the placebo group (18.2% vs. 40.0%, p = 0.048). The cumulative incidence of eczema during the first 12 months was reduced significantly in probiotic group (36.4% vs. 62.9%, p = 0.029); however, there was no difference in serum total IgE level or the sensitization against food allergens between the two groups.
Prenatal and postnatal supplementation with a mixture of B. bifidum BGN4, B. lactis AD011, and L. acidophilus AD031 is an effective approach in preventing the development of eczema in infants at high risk of allergy during the first year of life.
Ouwehand A, Leyer G, Carcano D. Probiotics reduce incidence and duration of respiratory tract infection symptoms in 3- to 5-year-old children. Pediatrics 2008;121; S115.
Probiotics are live microorganisms that have a beneficial effect on the host.
Our aim was to investigate whether consumption of probiotics would be able to reduce symptoms of respiratory tract infections during the winter season.
Children aged 3 to 5 years were recruited and randomly assigned to 1 of 3 groups to receive placebo (n = 92), Lactobacillus acidophilus NCFM (NCFM) (n = 77), or a combination of L acidophilus NCFM and Bifidobacterium lactis Bi-07 (NCFM+Bi-07) (n = 79). Probiotics were consumed daily at a dose of 1010 colony-forming units for 6 months from November to April. The study was performed in Shanghai, China, and approved by the local authorities.
The incidence of fever was reduced by 63% in the NCFM+Bi-07 group and by 48% in the NCFM group. Cough was reduced by 54% in the NCFM+Bi-07 group and by 42% in the NCFM group. Runny nose was reduced by 44% in the NCFM+Bi-07 group and by 9% in the NCFM group; the latter result was not significant. Antibiotic use was reduced by 80% in the NCFM+Bi-07 group and by 68% in the NCFM group. Children in the placebo group had, on average, 6.5 days with symptoms, those in the NCFM group had 4.5 days with symptoms, and those in the NCFM+Bi-07 group had 3.4 days with symptoms.
Daily consumption of NCFM and Bi-07 and of NCFM alone significantly reduced the incidence and duration of respiratory tract infection symptoms in children. The combination of the 2 probiotics tended to perform better than the NCFM alone
Lomax A, Calder P. Probiotics, Immune Function, Infection and Inflammation: A Review of the Evidence from Studies Conducted in Humans. Cur Pharma Des 2009;15(13):1428-1518.
A number of studies have been performed examining the influence of various probiotic organisms, either alone or in combination, on immune parameters, infectious outcomes, and inflammatory conditions in humans.
Some components of the immune response, including phagocytosis, natural killer cell activity and mucosal immunoglobulin A production (especially in children), can be improved by some probiotic bacteria. Other components, including lymphocyte proliferation, the production of cytokines and of antibodies other than immunoglobulin A appear less sensitive to probiotics.
Probiotics, including lactobacilli and bifidobacteria, administered to children can reduce incidence and duration of diarrhoea, but the precise effects depend upon the nature of the condition.
Probiotic supplementation can reduce the risk of travellers’ diarrhoea in adults, but does not affect duration. The effect of probiotics on other infectious outcomes is less clear.
Probiotics may benefit children and adults with irritable bowel syndrome and adults with ulcerative colitis; studies in Crohn’s Disease are less clear. Probiotics have little effect in rheumatoid arthritis.
Probiotic supplementation, especially with lactobacilli and bifidobacteria, can reduce risk and severity of allergic disease, particular atopic dermatitis; early supplementation appears to be effective.
Overall, the picture that emerges from studies of probiotics on immune, infectious and inflammatory outcomes in humans is mixed and there appear to be large species and strain differences in effects seen. Other reasons for differences in effects seen will include dose of probiotic organism used, duration of supplementation, characteristics of the subjects studied, sample size, and technical differences in how the measurements were made.
Peds ’10: LGG shown to significantly reduce frequency and severity of abdominal pain in children with IBS
Francavilla R, Miniello V, Magistà A, et al. A Randomized Controlled Trial of Lactobacillus GG in Children With Functional Abdominal Pain. Pediatrics 2010;126(6):e1445-e1452.
Our aim was to determine whether Lactobacillus rhamnosus GG (LGG) relieves symptoms in children with recurrent abdominal pain.
Patients and methods
A total of 141 children with irritable bowel syndrome (IBS) or functional pain were enrolled in 9 primary care sites and a referral center. Children entered a randomized, double-blind, placebo-controlled trial and received LGG or placebo for 8 weeks and entered follow-up for 8 weeks. The primary outcome was overall pain at the end of the intervention period. At entry and at the end of the trial, children underwent a double-sugar intestinal permeability test.
Compared with baseline, LGG, but not placebo, caused a significant reduction of both frequency (P < .01) and severity (P < .01) of abdominal pain. These differences still were significant at the end of follow-up (P < .02 and P < .001, respectively).
At week 12, treatment success was achieved in 48 children in the LGG group compared with 37 children in the placebo group (P < .03); this difference still was present at the end of follow-up (P < .03).
At entry, 59% of the children had abnormal results from the intestinal permeability test; LGG, but not placebo, determined a significant decrease in the number of patients with abnormal results from the intestinal permeability testing (P < .03). These effects mainly were in children with IBS.
LGG significantly reduces the frequency and severity of abdominal pain in children with IBS; this effect is sustained and may be secondary to improvement of the gut barrier.
Ling-Nan B, Mei-Hwei C, Yen-Hsuan N, et al. Lactobacillus casei rhamnosus Lcr35 in children with chronic constipation. Pediatr Int 2007;49:485-490.
The purpose of the present paper was to evaluate the efficacy of probiotics (Lactobacillus casei rhamnosus, Lcr35) for treating children with chronic constipation and to compare its effect with magnesium oxide (MgO) and placebo.
This double-blind placebo-controlled, randomized study enrolled 45 children under 10 years old with chronic constipation. They were randomly assigned to receive Lcr35 (8 × 108 c.f.u./day; n = 18), MgO (50 mg/kg/day; n = 18), or placebo (n = 9) orally twice daily for 4 weeks. Lactulose use (1 mL/kg per day) was allowed when no stool passage for 3 days was noted. Glycerin enema was used only when no defecation was noted for >5 days or abdominal pain was suffered due to stool impaction. Bacterial cultures of stool were performed before and after treatment to evaluate the change of intestinal flora. Comparisons of the frequency of defecation, consistency of stool and the use of lactulose or enema during the period of treatment were made among the three groups.
The patients who received MgO or probiotics had a higher defecation frequency (P = 0.03), higher percentage of treatment success (P = 0.01), less use of glycerin enema (P = 0.04) and less hard stool (P = 0.01) than the placebo group. There was no significant difference between MgO and probiotic groups in the aforementioned comparisons. The first effect of MgO (second week) on constipation was slightly earlier than that of probiotic (second to third week). Abdominal pain occurred less frequently in the probiotic group than in both the MgO and the placebo groups (P = 0.03). There was no statistically significant difference among the three groups in the use of lactulose, episodes of fecal soiling, and change of appetite. No adverse effect was noted in probiotic and placebo groups. Only one patient in the MgO group suffered from mild diarrhea.
Lcr35 was effective in treating children with chronic constipation. There is no statistically significant difference in efficacy between MgO and Lcr35, but less abdominal pain occurred when using Lcr35. Study with larger case number and longer follow up is needed in the future.
Clin Nutr ’10: CRT reports significant reduction in respiratory infections among children in day care centers with L. rhamnosus
Hojsak I, Snovak N, Abdovic S, et al. Lactobacillus GG in the prevention of gastrointestinal and respiratory tract infections in children who attend day care centers: a randomized, double-blind, placebo-controlled trial. Clin Nutr, 2010;29:312-316.
BACKGROUND & AIMS: The aim of our study was to investigate the role of Lactobacillus GG (LGG) in the prevention of gastrointestinal and respiratory tract infections in children who attend day care centers.
METHODS: We conducted a randomized, double-blind, placebo-controlled trial in 281 children who attend day care centers. They were randomly allocated to receive LGG at a dose of 10(9) colony-forming units in 100ml of a fermented milk product (LGG group, n=139) or placebo that was the same post-pasteurized fermented milk product without LGG (placebo group, n=142) during the 3-month intervention period.
RESULTS: Compared to the placebo group, children in the LGG group had a significantly reduced risk of upper respiratory tract infections (RR 0.66, 95% CI 0.52 to 0.82, NNT 5, 95% CI 4 to 10), a reduced risk of respiratory tract infections lasting longer than 3 days (RR 0.57, 95% CI 0.41 to 0.78, NNT 5, 95% CI 4 to 11), and a significantly lower number of days with respiratory symptoms (p<0.001). There was no risk reduction in regard to lower respiratory tract infections (RR 0.82, 95% CI 0.24 to 2.76). Compared with the placebo group, children in the LGG group had no significant reduction in the risk of gastrointestinal infections (RR 0.63, 95% CI 0.38 to 1.06), vomiting episodes (RR 0.60, 95% CI 0.29 to 1.24), and diarrheal episodes (RR 0.63, 95% CI 0.35 to 1.11) as well as no reduction in the number of days with gastrointestinal symptoms (p=0.063).
CONCLUSION: LGG administration can be recommended as a valid measure for decreasing the risk of upper respiratory tract infections in children attending day care centers.
Peds ’10: Study shows reduced risk for nosocomial GI and respiratory tract infections among young children given L. rhamnosus
Hojsak I, Abdovic S, Szajewska H, et al. Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections. Pediatrics, 2010;125:e1171-e1177.
OBJECTIVE: The incidence of nosocomial infections, predominantly gastrointestinal and respiratory, in children in developed countries is high, ranging from 5% to 44%. There is no effective strategy for preventing these infections. The objective of our study was to investigate the role of Lactobacillus GG (LGG) in preventing nosocomial gastrointestinal and respiratory tract infections at a pediatric hospital. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of 742 hospitalized children. They were randomly allocated to receive for their hospitalization LGG at a dose of 10(9) colony-forming units in 100 mL of a fermented milk product (LGG group, n = 376) or placebo that was the same postpasteurized fermented milk product without LGG (placebo group, n = 366).
RESULTS: In the LGG group, compared with the placebo group, we found a significantly reduced risk for gastrointestinal infections (relative risk [RR]: 0.40 [95% confidence interval (CI): 0.25-0.70]; number needed to treat: 15 [95% CI: 9-34)], respiratory tract infections (RR: 0.38 [95% CI: 0.18-0.85]; number needed to treat: 30 [95% CI: 16-159]), vomiting episodes (RR: 0.5 [95% CI: 0.3-0.9]), diarrheal episodes (RR: 0.24 [95% CI: 0.10-0.50]), episodes of gastrointestinal infections that lasted >2 days (RR: 0.40 [95% CI: 0.25-0.70]), and episodes of respiratory tract infections that lasted >3 days (RR: 0.4 [95% CI: 0.2-0.9]). Groups did not differ in hospitalization duration (P = .1).
CONCLUSIONS: LGG administration can be recommended as a valid measure for decreasing the risk for nosocomial gastrointestinal and respiratory tract infections in pediatric facilities.
BJN ’09: Significant reduction in acute otitis media in early infancy with L. rhamnosus and B. lactis
Rautava S, Salminen S, Isolauri E. Specific probiotics in reducing the risk of acute infections in infancy–a randomised, double-blind, placebo-controlled study. Br J Nutr, 2009;101:1722-1726.
A randomised, double-blind, placebo-controlled study was conducted to determine whether probiotics might be effective in reducing the risk of infections in infancy. Infants requiring formula before the age of 2 months were recruited from community well-baby clinics. Infant formula supplemented with the probiotics Lactobacillus rhamnosus GG and Bifidobacterium lactis Bb-12 or placebo was administered daily until the age of 12 months. Incidence of early infections (before the age of 7 months) and incidence of recurrent (three or more) infections during the first year of life were recorded as the main outcome measures of the study.
During the first 7 months of life, seven out of thirty-two (22 %) infants receiving probiotics and twenty out of forty (50 %) infants receiving placebo experienced acute otitis media (risk ratio (RR) 0.44 (95 % CI 0.21, 0.90); P = 0.014) and antibiotics were prescribed for ten out of thirty-two (31 %) infants receiving probiotics and twenty-four out of forty (60 %) infants receiving placebo (RR 0.52 (95 % CI 0.29, 0.92); P = 0.015). During the first year of life, nine out of thirty-two (28 %) infants receiving probiotics and twenty-two out of forty (55 %) infants receiving placebo encountered recurrent respiratory infections (RR 0.51 (95 % CI 0.27, 0.95); P = 0.022).
These data suggest that probiotics may offer a safe means of reducing the risk of early acute otitis media and antibiotic use and the risk of recurrent respiratory infections during the first year of life. Further clinical trials are warranted.