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

Constipation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02446080
• Other study ID #: CUUnivates
• Status: Completed
• Phase: N/A
• First received: May 13, 2015
• Last updated: May 14, 2015
• Start date: December 2014
• Est. completion date: March 2015

Study information

• Verified date: May 2015
• Source: Centro Universitário Univates
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: March 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 50 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Constipation

Intervention

Dietary Supplement:
• Milk drink with probiotic culture
The Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture
• Milk drink
The control group was asked to drink 150 ml per day of dairy drinks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Centro Universitário Univates

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of symptoms of constipation	Improvement of symptoms of constipation by ROME III criteria and Bristol scale.	60 days	Yes
Secondary	Increased number of bowel movements	Increased number of bowel movements per week and is quoted by ROME III criteria.	60 days	Yes