Consumption of Milk Drink and Constipation

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02091115
• Other study ID #: 072013
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: March 14, 2014
• Last updated: March 18, 2014
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: March 2014
• Source: Centro Universitário Univates
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBrazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• dairy drink with probiotic culture
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

Locations

Country	Name	City	State
Brazil	University Center Univates	Lajeado	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Univates

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Appearance of feces.	Bristol scale been applied in July 2013 and in September 2013	Up to two months	No
Primary	Decrease in symptoms of constipation	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.	Up to two months	No
Secondary	Increase in frequency evacuations	The frequency evacuations have been questions to participants in July 2013 and after the consumption of dairy drink in September 2013	Up to two months	No