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Consumption of Milk Drink and Constipation

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ClinicalTrials.gov Identifier: NCT02091115
Recruitment Status : Completed
First Posted : March 19, 2014
Last Update Posted : March 19, 2014
Sponsor:
Information provided by (Responsible Party):
Thaís Rodrigues Moreira, Centro Universitário Univates

Brief 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.

Condition or disease Intervention/treatment Phase
Constipation Dietary Supplement: dairy drink with probiotic culture Dietary Supplement: Dairy drink Phase 1 Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Influence of the Consumption of Milk Drink With Bifidobacterium Animalis in Symptoms of Constipation.
Study Start Date : July 2013
Actual Primary Completion Date : July 2013
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arm Intervention/treatment
Placebo Comparator: Dairy drink
Patients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily.
Dietary Supplement: Dairy drink
Active Comparator: Dairy drink with probiotic culture
Patients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  1. Appearance of feces. [ Time Frame: Up to two months ]
    Bristol scale been applied in July 2013 and in September 2013



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02091115


Locations
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Brazil
University Center Univates
Lajeado, Rio Grande do Sul, Brazil, 95900-000
Sponsors and Collaborators
Centro Universitário Univates
Investigators
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Principal Investigator: Thaís R Moreira, Professor University Center Univates

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Responsible Party: Thaís Rodrigues Moreira, Master in Medical Sciences and Professor, Centro Universitário Univates
ClinicalTrials.gov Identifier: NCT02091115    
Other Study ID Numbers: 072013
First Posted: March 19, 2014    Key Record Dates
Last Update Posted: March 19, 2014
Last Verified: March 2014
Keywords provided by Thaís Rodrigues Moreira, Centro Universitário Univates:
Constipation
ROMA III criteria
Scale Bristol
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Signs and Symptoms