Skip to main content
OpenTrials
Completed

NCT Number: NCT02091115

Consumption of Milk Drink and Constipation

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Center Univates

Lajeado, Rio Grande do Sul, 95900-000, Brazil

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women

Exclusion criteria

  • diabetic women,
  • pregnant,
  • breastfeeding women,
  • gastrointestinal symptoms,
  • gastrointestinal pathologies preliminary,
  • current or recent use of antibiotics, antiinflammatory or other drugs,
  • womens with pathologies that alter the bowel habits,
  • food allergies and intolerances,
  • ulcerative colitis,
  • Crohn's disease and irritable bowel syndrome,
  • patients having lactose intolerance or do not like milk drink,
  • patients showing them to use other types of probiotic food, prebiotic and symbiotic.

Treatment and study plan

dairy drink with probiotic culture

Dietary Supplement

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.

Dairy drink

Dietary Supplement

Primary outcomes

  1. Decrease in symptoms of constipation

    Time frame: Up to two months

    First application of Rome III criteria and Scale Bristol in July 2013. And the second measure has occurred after the consumption of dairy drink for 60 days and was held in September 2013.

Secondary outcomes

  1. Increase in frequency evacuations

    Time frame: Up to two months

    The frequency evacuations have been questions to participants in July 2013 and after the consumption of dairy drink in September 2013

Other outcomes

  1. Appearance of feces.

    Time frame: Up to two months

    Bristol scale been applied in July 2013 and in September 2013

Sponsors and collaborators

Lead sponsor

Centro Universitário Univates

Other

Registry information

Official study title

Influence of the Consumption of Milk Drink With Bifidobacterium Animalis in Symptoms of Constipation.

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 19, 2014
Registry last updated
Mar 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.