Consumption of Milk Drink and Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Constipation is a disorder which can be associated with various pathologies or could also be
      an effect of the consumption of drugs, improper diet and life style. Is increasingly common
      the utilization of probiotics in foods. Probiotics are defined as live microorganisms
      administered in adequate amounts confer a health benefit to the host, the most widely used
      for milk-based drinks are lactic bacteria Lactobacillus and Bifidobacterium. The objective of
      the present study is to assess the effectiveness of the consumption of dairy beverage
      enriched with probiotic for the treatment of the symptoms of constipation.
    

Detailed description: 
      To that randomized clinical trial, double blind controlled, were recruited in the city of
      Teutônia - RS - Brazil, 49 women aged 20-50 years. Patients with pathologies that alter the
      bowel habits, such as food allergies and intolerances; diabetic women, pregnant,
      breastfeeding women, gastrointestinal symptoms, gastrointestinal pathologies preliminary,
      current or recent use of antibiotics, anti-inflammatory, laxatives or other drugs were
      excluded. Ulcerative colitis, Crohn's disease and irritable bowel syndrome, patients having
      lactose intolerance or do not like milk drink, besides patients showing them to use other
      types of probiotic food, prebiotic and symbiotic.

      Study participants have been diagnosed with constipation according to the recommendations
      established by the Rome III criteria (World Gastroenterology Organization) and the Bristol
      Scale (World Gastroenterology Organization). Answered to a questionnaire on the general data,
      with questions related to the consumption of fruits and vegetables, meats, milk products,
      water intake, alcohol intake, smoking and physical activity practice.

      Were randomly divided in two groups, one group received probiotic culture dairy drink
      (intervention group), animalis bifidobacterium, containing 3.2 x 107 and the other group has
      received dairy drink (control group). Was directed towards participants the consumption of
      one cup (150 ml) of dairy drink per day, preferably on an empty stomach or morning snack,
      during period of 60 days. The dairy beverages have been donated by a company, bottled in 1
      liter bottles, transported in appropriate thermal boxes and delivered in three stages, every
      twenty days in the residence of the participants.

      After 60 consumption days of dairy beverage new reviews with the participants were conducted,
      they are nutritional assessment and implemented the Rome III Criteria and Scale Bristol
      again. To do this the weight, height, waist and hip circumference were measured. To measure
      was utilized digital balance with capacity of 300 kg and inelastic tape with an extension of
      1.5 m. Was recommended for participants to stay barefoot and use light clothing. Thereafter,
      we calculated the Body Mass Index (BMI), waist-hip ratio and risk for cardiovascular disease,
      classified according to the parameters established by the World Health Organization (1998).

      The guidelines on how consume and storing the dairy drink were provided to the participants
      before the distribution of products. A dairy beverage should be consumed every day
      preferentially in the morning, be agitated before consuming, not heat it, stored
      refrigerated. During the study period, participants were instructed not to change their
      eating habits, physical activity practice, fluid intake and not make use of other products
      with probiotic culture.

      Quantitative variables were described using mean and standard deviation or median and
      interquartile range. Categorical variables were described by absolute and relative
      frequencies. To compare means between groups, Student's t-test for independent samples was
      applied. In case of asymmetry, the Mann-Whitney test was used. To compare proportions, the
      chi-square test was applied. To evaluate the ROME III and Bristol-scale pre-and
      post-intervention, the Wilcoxon test was applied. Data analysis was performed using the
      Statistical Package for Social Sciences (SPSS) version 18.0. The level of statistical
      significance was 5% (p ≤ 0.05).
    

Intervention name(s): dairy drink with probiotic culture; Dairy drink
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The participants were instructed to consume the dairy drink with probiotic culture containing animalis bifidobacterium with 3.2 x 107 UFC for 60 days and a glass of 150 ml daily.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Constipation; ROMA III criteria; Scale Bristol