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
About this trial
This is an interventional treatment trial for Constipation focused on measuring Constipation, Probiotics, Women
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.
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
NCT ID
NCT02446080
First Posted
May 13, 2015
Last Updated
May 14, 2015
Sponsor
Centro Universitário Univates
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
Learn more about this trial
Drink Milk Consumption Benefits With Culture Probiotic in the Treatment of Constipation
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