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Consumption of Milk Drink and Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Phase 1
Locations
Brazil
Study Type
Interventional
Intervention
dairy drink with probiotic culture
Dairy drink
Sponsored by
Centro Universitário Univates
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Constipation focused on measuring Constipation, ROMA III criteria, Scale Bristol

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Center Univates

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Dairy drink

Dairy drink with probiotic culture

Arm Description

Patients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily.

Patients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
March 14, 2014
Last Updated
March 18, 2014
Sponsor
Centro Universitário Univates
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1. Study Identification

Unique Protocol Identification Number
NCT02091115
Brief Title
Consumption of Milk Drink and Constipation
Official Title
Influence of the Consumption of Milk Drink With Bifidobacterium Animalis in Symptoms of Constipation.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centro Universitário Univates

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constipation
Keywords
Constipation, ROMA III criteria, Scale Bristol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dairy drink
Arm Type
Placebo Comparator
Arm Description
Patients received dairy drink for 60 days and were instructed to consume a glass of 150 mL daily.
Arm Title
Dairy drink with probiotic culture
Arm Type
Active Comparator
Arm Description
Patients received dairy drink with probiotic culture for 60 days and were instructed to consume a glass of 150 mL daily.
Intervention Type
Dietary Supplement
Intervention Name(s)
dairy drink with probiotic culture
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Dairy drink
Primary Outcome Measure Information:
Title
Decrease in symptoms of constipation
Description
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.
Time Frame
Up to two months
Secondary Outcome Measure Information:
Title
Increase in frequency evacuations
Description
The frequency evacuations have been questions to participants in July 2013 and after the consumption of dairy drink in September 2013
Time Frame
Up to two months
Other Pre-specified Outcome Measures:
Title
Appearance of feces.
Description
Bristol scale been applied in July 2013 and in September 2013
Time Frame
Up to two months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thaís R Moreira, Professor
Organizational Affiliation
University Center Univates
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Center Univates
City
Lajeado
State/Province
Rio Grande do Sul
ZIP/Postal Code
95900-000
Country
Brazil

12. IPD Sharing Statement

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Consumption of Milk Drink and Constipation

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