Effect of the consumption of a fermented dairy product containing Bifidobacterium lactis DN-173 010 on constipation in childhood: a multicentre randomised controlled trial (NTRTC: 1571)

<p>Abstract</p> <p>Background</p> <p>Constipation is a frustrating symptom affecting 3% of children worldwide. Randomised controlled trials show that both polyethylene glycol and lactulose are effective in increasing defecation frequency in children with constipation. However, in 30–50%, these children reported abdominal pain, bloating, flatulence, diarrhoea, nausea and bad taste of the medication. Two recent studies have shown that the fermented dairy product containing <it>Bifidobacterium lactis </it>strain DN-173 010 is effective in increasing stool frequency in constipation-predominant irritable bowel syndrome patients with a defecation frequency < 3/week and in constipated women with a defecation frequency < 3/week. Goal of this study is to determine whether this fermented dairy product is effective in the treatment of constipated children with a defecation frequency < 3/week.</p> <p>Methods/design</p> <p>It is a two nation (The Netherlands and Poland) double-blind, placebo-controlled randomised multicentre trial in which 160 constipated children (age 3–16 years) with a defecation frequency <3/week will be randomly allocated to consume a fermented dairy product containing <it>Bifidobacterium lactis </it>DN-173 010 or a control product, twice a day, for 3 weeks. During the study all children are instructed to try to defecate on the toilet for 5–10 minutes after each meal (3 times a day) and daily complete a standardized bowel diary. Primary endpoint is stool frequency. Secondary endpoints are stool consistency, faecal incontinence frequency, pain during defecation, digestive symptoms (abdominal pain, flatulence), adverse effects (nausea, diarrhoea, bad taste) and intake of rescue medication (Bisacodyl). Rate of success and rate of responders are also evaluated, with success defined as ≥ 3 bowel movements per week and ≤1 faecal incontinence episode over the last 2 weeks of product consumption and responder defined as a subject reporting a stool frequency ≥ 3 on the last week of product consumption. To demonstrate that the success percentage in the intervention group will be 35% and the success percentage in the control group (acidified milk without ferments, toilet training, bowel diary) will be 15%, with alpha 0.05 and power 80%, a total sample size of 160 patients was calculated.</p> <p>Conclusion</p> <p>This study is aimed to show that the fermented dairy product containing <it>Bifidobacterium lactis </it>strain DN-173 010 is effective in increasing stool frequency after 3 weeks of product consumption in children with functional constipation and a defecation frequency < 3/week.</p

Does maternal pre-pregnancy overweight or obesity influence offspring's growth patterns from birth up to 7 years? The ABCD-study

Background: Maternal pre-pregnancy overweight is known to program offspring for adverse health outcomes later in life. Aims: To investigate how growth patterns of weight, height and BMI from birth to 7 years differ according to maternal pre-pregnancy weight (normal weight, overweight and obesity), with specific attention for sex differences. Study design: Prospective multi-ethnic ABCD-study. Subjects: 3805 mother-child pairs were included. Self-reported maternal pre-pregnancy body mass index was categorized into: normal weight (18.5-25 kg/m(2); n = 3354), overweight (25-30 kg/m(2); n = 711) and obesity (>= 30 kg/m(2); n = 241). Outcome measures: Population-specific growth patterns were used to compute SD-scores for weight, height and BMI (on average 12.7 (SD = 2.6) measurements for each child) for term born boys and girls separately. Mixed effect models were fitted to these SD-scores to determine the effect of pre-pregnancy EMI category on postnatal growth, corrected for maternal characteristics. Results: Compared to children of mothers with normal weight before pregnancy, children of overweight mothers grew faster in weight and BMI (boys and girls) and children of obese mothers grew faster in height (only girls), weight and BMI (boys and girls) during the first years of life. The differences seemed to increase with age and were in general larger in girls. Conclusion: Maternal overweight and obesity impact on offspring's weight, height and BMI growth pattern with increasing differences when children age. Effects were in general stronger for girls. These results suggest that a healthy weight before pregnancy may be beneficial for optimal weight, height and BMI growth in the offsprin

Fermented Milk Containing Bifidobacterium lactis DN-173 010 in Childhood Constipation: A Randomized, Double-Blind, Controlled Trial

BACKGROUND: Constipation is a frustrating symptom affecting 3% of children worldwide. A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women. Our aim was to assess the effects of this product in constipated children. METHODS: In this prospective randomized, double-blind, controlled trial, 159 constipated children (defecation frequency <3 times per week) were randomly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 (n = 79) or a control product (n = 80) twice a day for 3 weeks. The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption. Analyses were by intention to treat. RESULTS: Eleven children did not return to any follow-up visit (5 in the probiotic group, 6 in the control group) and were therefore excluded from the final analysis. Thus, 74 children in each group were analyzed. The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups, but the difference was not statistically significant (2.9 +/- 3.2 in probiotic group versus 2.6 +/- 2.6 in control group, P = .35). There were no serious adverse events. CONCLUSIONS: In constipated children, the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency, but this increase was comparable in the control group. There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation. Pediatrics 2011;127:e1392-e139

Characteristics of the study population.

<p>Characteristics of the study population.</p

Pre-pregnancy weight status, early pregnancy lipid profile and blood pressure course during pregnancy: The ABCD study

<div><p>Objective</p><p>Although pre-pregnancy weight status and early pregnancy lipid profile are known to influence blood pressure course during pregnancy, little is known about how these two factors interact. The association between pre-pregnancy weight status and blood pressure course during pregnancy was assessed in the prospective ABCD study and the role (independent/mediating/moderating) of early pregnancy lipid profile in this association was determined.</p><p>Methods</p><p>We included 2500 normal weight (<25 kg/m2) and 600 overweight (≥25 kg/m2) women from the prospective ABCD-study with available measurements of non-fasting early pregnancy lipids [median (IQR): 13 (12–14) weeks of gestation] and blood pressure during pregnancy [mean (SD) = 10 (2.3)]. Lipids (triglycerides, total cholesterol, apolipoprotein A1, apolipoprotein B and free fatty acids) were divided into tertiles. Multilevel piecewise linear spline models were used to describe the course of systolic and diastolic blood pressure (SBP/DBP) in four time periods during gestation for overweight and normal weight women.</p><p>Results</p><p>Both SBP (5.3 mmHg) and DBP (3.9 mmHg) were higher in overweight compared to normal weight women and this difference remained the same over all four time periods. The difference in SBP and DBP was not mediated or moderated by the lipid profile. Lipid profile had an independent positive effect on both SBP (range 1.3–2.2 mmHg) and DBP (0.8–1.1 mmHg), but did not change blood pressure course.</p><p>Conclusions</p><p>Both pre-pregnancy weight status and early pregnancy lipid profile independently increase blood pressure during pregnancy. Improving pre-pregnancy weight status and early pregnancy lipid profile might result in a healthier blood pressure course during pregnancy.</p></div

Maternal prepregancy BMI and lipid profile during early pregnancy are independently associated with offspring's body composition at age 5-6 years: the ABCD study

There is growing evidence that disturbances in maternal metabolism and, subsequently, intrauterine conditions affect foetal metabolism. Whether this has metabolic consequences in offspring later in life is not fully elucidated. We investigated whether maternal pre-pregnancy body mass index (pBMI) is associated with offspring's adiposity at age 5-6 years and whether this association is mediated by the mother's lipid profile during early pregnancy. Data were derived from a multi-ethnic birth cohort, the Amsterdam Born Children and their Development (ABCD) study (inclusion 2003-2004). During early gestation mothers completed a questionnaire during pregnancy (pBMI) and random non-fasting blood samples were analysed for total cholesterol (TC), triglycerides (TG), apolipoprotein A1 (ApoA1), apolipoprotein B (ApoB) and total free fatty acids (FFA) in early gestation. At age 5-6 years, child's BMI, waist-to-height-ratio (WHtR) and fat% were assessed. Only non-diabetic mothers with at term-born children were included (n = 1727). Of all women, 15.1% were overweight(BMI: 25-29.9 kg/m2) and 4.3% were obese (BMI≥30 kg/m2). After adjustments for confounders, every unit increase in pBMI was linearly associated with various offspring variables: BMI (β 0.10; 95% CI 0.08-0.12), WHtR*100 (β 0.13; 95% CI 0.09-0.17), fat% (β 0.21; 95% CI 0.13-0.29) and increased risk for overweight (OR:1.15; 95% CI 1.10-1.20). No convincing proof for mediation by maternal lipid profile during early gestation was found. Moreover, maternal FFA was associated with the child's fat percentage, BMI and risk for overweight. Maternal ApoB and TC were positively associated with the offspring's fat percentage and maternal TG was positively associated with their children's WHtR. Both pBMI and maternal lipids during early pregnancy are independently related to offspring adiposit

Flowchart of inclusion of the study participants.

<p>Flowchart of inclusion of the study participants.</p

Association between pre-pregnancy body mass index (pBMI) and diastolic blood pressure course during pregnancy, with maternal lipids.

<p>Association between pre-pregnancy body mass index (pBMI) and diastolic blood pressure course during pregnancy, with maternal lipids.</p

Tertiles of the investigated lipids^#.

<p>Tertiles of the investigated lipids^{<a href="http://www.plosone.org/article/info:doi/10.1371/journal.pone.0177554#t002fn002" target="_blank">#</a>}.</p

Blood pressure during pregnancy stratified for maternal weight status and tertiles of Apolipoprotein B^#.

<p>SBP = systolic blood pressure; DBP = diastolic blood pressure. # Apolipoprotein B was determined in non-fasting blood samples drawn at a median of 13 (IQR = 12–14) weeks of gestation.</p