Time to treatment response of a magnesium- and sulphate-rich natural mineral water in functional constipation.

OBJECTIVES: First-line recommendations for the management of functional constipation include nutritional-hygienic measures. We previously showed that a natural mineral water rich in sulphates and magnesium (Hépar) is efficient in the treatment of functional constipation. The aim of this study was to consolidate those first results and determine a precise time to respond to Hépar. METHODS: This multicenter, randomized, double-blind, controlled study of the effect of Hépar on stool consistency and frequency in functional constipation included 226 outpatients. After washout, patients used 1.5 L of water daily, including 1 L of Hépar or of low-mineral water, during 14 d. In addition to a daily reporting of stool consistency by the patient, an expert investigator blindly analyzed stool consistency (Bristol stool scale) based on photographs taken by the patient. RESULTS: The primary endpoint was met. Treatment response was more frequent in the Hépar arm than in the control group at day 14 (50% versus 29%, respectively; P = 0.001). Mean time to treatment response was shorter in the Hépar group (6.4 d) than in the control arm (7.3 d; P = 0.013). Concomitant stool scoring was available for 60% of the patients. Scores given to 79% of the stools were similar between the patient and the expert (differences ≤1). Safety analyses showed excellent results. CONCLUSION: This study confirms the efficacy and safety of Hépar in the treatment of functional constipation and shows that it is associated with a response within 7 d. Hépar could be a safe response to the current absence of first-line medication in the treatment of functional constipation.

Incidence of infectious diseases in infants fed follow-on formula containing synbiotics: an observational study.

AIM: Infectious diseases in infants are a major public health issue. Synbiotic-enriched formulas (EF) are intended to mimic the beneficial effects of human milk on infectious diseases. We performed an observational study in infants switching to follow-on formula to determine the effects of synbiotic-enriched formula compared to standard formula (SF). METHODS: We recorded family characteristics, medical history and growth data, as well as the symptoms, severity and treatment of infectious diseases. Main outcome measures were compared after adjustments for baseline characteristics. RESULTS: Between January and June 2007, 771 healthy infants were included in the study; 35.4% experienced at least one infectious disease during the 3-month study period. The most common were upper respiratory tract (24.1%), otitis (6.6%) and gastrointestinal infectious diseases (5.0%). Infants fed synbiotic-enriched formula had fewer infectious diseases overall (EF: 31.0%; SF: 40.6%; p = 0.005) and significantly fewer gastrointestinal infectious diseases (EF: 3.5%; SF: 6.8%; p = 0.03). During follow-up, weight gain was significantly higher (p = 0.0467) in infants fed synbiotic-enriched formula (18.3 ± 8.7 g/day) versus SF (16.9 ± 7.5 g/day). CONCLUSIONS: Supplementation with synbiotics may have beneficial effects on the incidence of infectious disease and growth in infants. Further studies are needed determine optimal doses and composition of synbiotics in infant formula.

Family dietary coaching to improve nutritional intakes and body weight control: a randomized controlled trial.

OBJECTIVE: To test the hypothesis that family dietary coaching would improve nutritional intakes and weight control in free-living (noninstitutionalized) children and parents. DESIGN: Randomized controlled trial. SETTING: Fifty-four elementary schools in Paris, France. PARTICIPANTS: One thousand thirteen children (mean age, 7.7 years) and 1013 parents (mean age, 40.5 years). INTERVENTION: Families were randomly assigned to group A (advised to reduce fat and to increase complex carbohydrate intake), group B (advised to reduce both fat and sugar and to increase complex carbohydrate intake), or a control group (given no advice). Groups A and B received monthly phone counseling and Internet-based monitoring for 8 months. OUTCOME MEASURES: Changes in nutritional intake, body mass index (calculated as weight in kilograms divided by height in meters squared), fat mass, physical activity, blood indicators, and quality of life. RESULTS: Compared with controls, participants in the intervention groups achieved their nutritional targets for fat intake and to a smaller extent for sugar and complex carbohydrate intake, leading to a decrease in energy intake (children, P < .001; parents, P = .02). Mean changes in body mass index were similar among children (group A, + 0.05, 95% confidence interval [CI], - 0.06 to 0.16; group B, + 0.10, 95% CI, - 0.03 to 0.23; control group, + 0.13, 95% CI, 0.04-0.22; P = .45), but differed in parents (group A, + 0.13, 95% CI, - 0.01 to 0.27; group B, - 0.02, 95% CI, - 0.14 to 0.11; control group, + 0.24, 95% CI, 0.13-0.34; P = .001), with a significant difference between group B and the control group (P = .01). CONCLUSIONS: Family dietary coaching improves nutritional intake in free-living children and parents, with beneficial effects on weight control in parents. Trial Registration clinicaltrials.gov Identifier: NCT00456911.

The effects of regular consumption of short-chain fructo-oligosaccharides on digestive comfort of subjects with minor functional bowel disorders.

A comparative, randomised, double-blind trial was performed in the medical departments of five hospitals to study the effects of regular consumption of short-chain fructo-oligosaccharides (sc-FOS) on the digestive comfort of subjects with minor functional bowel disorders (FBD). In step 1, 2235 subjects were questioned to assess the incidence and intensity of digestive disorders. In step 2, 105 of these patients diagnosed with minor FBD were randomised into two groups to receive either 5 g sc-FOS or 5 g placebo (sucrose and maltodextrins) per d over a 6-week period. The incidence and intensity of digestive disorders were assessed at the end of the treatment period (day 43) using the step 1 questionnaires. A quality-of-life questionnaire was also completed at the start and end of the treatment period to assess potential effects on well-being and social performance. In step 1, 44 % of the subjects questioned presented FBD, of whom 57.1 % suffered from minor FBD. In step 2, on day 43, the intensity of digestive disorders decreased by 43.6 % in the sc-FOS group v. a 13.8 % increase in the placebo group (P = 0.026). Symptoms were experienced less frequently by 75.0 % of subjects in the sc-FOS group, while 53.8 % of controls experienced no change (P = 0.064). Using the functional digestive disorders quality of life questionnaire, the discomfort item scores increased in the sc-FOS group (P = 0.031). However, expressed as change in quality of life (improvement, worsening or unchanged), daily activities were significantly improved in the sc-FOS group (P = 0.022). Regular consumption of sc-FOS may improve digestive comfort in a working population not undergoing medical treatment.