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

NCT02446080 | Completed

• 1 other identifier: CUUnivates
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Constipation

Keywords

Constipation; Probiotics; Women

Outcome Measures

Primary Outcomes (1)

• Improvement of symptoms of constipation

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

  60 days

Secondary Outcomes (1)

• Increased number of bowel movements

  60 days

Study Arms (2)

Probiotic Group

EXPERIMENTAL

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

Dietary Supplement: Milk drink with probiotic culture

Control Group

ACTIVE COMPARATOR

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

Dietary Supplement: Milk drink

Interventions

Milk drink with probiotic culture DIETARY_SUPPLEMENT

The Probiotc group was asked to drink 150 ml per day of dairy drinks with probiotic culture

Probiotic Group

Milk drink DIETARY_SUPPLEMENT

The control group was asked to drink 150 ml per day of dairy drinks.

Control Group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centro Universitário Univates: lead

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nutrition Course Professor

Study Record Dates

• First Submitted: May 13, 2015
• First Posted: May 15, 2015
• Study Start: December 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: March 1, 2015
• Last Updated: May 15, 2015

Record last verified: 2015-05