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Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation

Primary Purpose

Constipation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Milk drink with probiotic culture
Milk 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, Probiotics, Women

Eligibility Criteria

20 Years - 50 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Having a diagnosis of constipation;
  • Have aged between 20 and 50 years;
  • Being female.

Exclusion Criteria:

  • Patients with diabetes;
  • Patients pregnant and lactating women;
  • Patients with diarrhea, with previous gastrointestinal disorders;
  • Current or recent consumption of antibiotics, anti-inflammatory drugs, laxatives or other drugs;
  • Patients with diseases that alter bowel habits, such as food allergies and intolerances, ulcerative colitis, chron's disease and irritable bowel syndrome.
  • Patients who have lactose intolerance or dislike of milk drink.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Probiotic Group

    Control Group

    Arm Description

    Milk drink with probiotic culture (150 mL/daily) for 60 days.

    Milk drink (150 mL/daily) for 60 days.

    Outcomes

    Primary Outcome Measures

    Improvement of symptoms of constipation
    Improvement of symptoms of constipation by ROME III criteria and Bristol scale.

    Secondary Outcome Measures

    Increased number of bowel movements
    Increased number of bowel movements per week and is quoted by ROME III criteria.

    Full Information

    First Posted
    May 13, 2015
    Last Updated
    May 14, 2015
    Sponsor
    Centro Universitário Univates
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02446080
    Brief Title
    Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation
    Official Title
    The Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation Women
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2014 (undefined)
    Primary Completion Date
    February 2015 (Actual)
    Study Completion Date
    March 2015 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Constipation is defined as a disorder characterized by persistent difficulty to evacuate or a feeling of incomplete evacuation and / or infrequent bowel movements. Many factors contribute to the onset of constipation, such as changes in dietary intake and fluid intake, decrease in consumption of products containing fiber, intake of drugs or laxatives, decreased intestinal motility and physical inactivity. The objective was to evaluate the effect of consumption of dairy products with probiotics on constipation. Randomized double-blind clinical trial in the city of Bom Retiro do Sul / RS, Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack.
    Detailed Description
    Randomized double blind clinical trial conducted at the health center of the city of Bom Retiro do Sul / RS, Brazil, from December 2014 to March 2015. The study began after approval by the Ethics Committee of the Research Center University Univates (COEP), Lajeado. Brazil. They were recruited 60 female patients aged 20-50 years after application of the Rome III criteria (World Gastroenterology Organization, 2010) and Range Bristol (World Gastroenterology Organisation, 2010) were diagnosed with constipation. Patients were randomized into two groups, where one group will receive the milk drink with probiotics and the other group will receive a probiotic milk drink without (control group). The milk beverage consumption period shall be 60 days where each patient will consume 150 ml of milk drink a day, with breakfast or morning snack. The milk drink was provided in the homes of participants and the health center of the city of Bom Retiro do Sul once a week. At the beginning of treatment and at the end of treatment that will last 60 days, will be delivered to Bristol Scale and the criteria of Rome III, so as to verify the improvement or not of constipation. Patients who agree to participate in the study signed a consent form IC. Will be the orientation for the volunteers not to consume yogurt and other cultured milks with probiotics, will also be oriented to maintain the same diet and lifestyle when they were constipated, thus, check for improvement in constipation with the use of probiotics . Inclusion criteria: Having a diagnosis of constipation; Be aged between 20 and 50 years; being female. Data collection brings no risk or damage to entrant, but can cause discomfort and embarrassment to meet the criteria of Rome III and Bristol Scale and the time that will have to spend 10 to 15 minutes. Such issues will be mitigated by the fact that the interview be individualized and the participant have at their disposal a private room to answer the questionnaires, only with the presence of the academic. Participants will not obtain any financial benefit, only the benefits of milk drink with probiotics and how much consumption adds to your health. It is also important to note that participation in the study will not result in expenses.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Constipation
    Keywords
    Constipation, Probiotics, Women

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    60 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Probiotic Group
    Arm Type
    Experimental
    Arm Description
    Milk drink with probiotic culture (150 mL/daily) for 60 days.
    Arm Title
    Control Group
    Arm Type
    Active Comparator
    Arm Description
    Milk drink (150 mL/daily) for 60 days.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Milk drink with probiotic culture
    Intervention Description
    The Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Milk drink
    Intervention Description
    The control group was asked to drink 150 ml per day of dairy drinks.
    Primary Outcome Measure Information:
    Title
    Improvement of symptoms of constipation
    Description
    Improvement of symptoms of constipation by ROME III criteria and Bristol scale.
    Time Frame
    60 days
    Secondary Outcome Measure Information:
    Title
    Increased number of bowel movements
    Description
    Increased number of bowel movements per week and is quoted by ROME III criteria.
    Time Frame
    60 days

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Having a diagnosis of constipation; Have aged between 20 and 50 years; Being female. Exclusion Criteria: Patients with diabetes; Patients pregnant and lactating women; Patients with diarrhea, with previous gastrointestinal disorders; Current or recent consumption of antibiotics, anti-inflammatory drugs, laxatives or other drugs; Patients with diseases that alter bowel habits, such as food allergies and intolerances, ulcerative colitis, chron's disease and irritable bowel syndrome. Patients who have lactose intolerance or dislike of milk drink.

    12. IPD Sharing Statement

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