Effect of the Consumption of a Cheese Enriched With Probiotic Organisms in Improving Symptoms of Constipation

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thaís Rodrigues Moreira, Centro Universitário Univates
ClinicalTrials.gov Identifier:
NCT01680432
First received: August 6, 2012
Last updated: September 6, 2012
Last verified: September 2012
  Purpose

Constipation is a common gastrointestinal motility disorder, chronic condition that often negatively affects the daily lives of patients due to their symptoms, such as infrequent stools, hard stools, straining or painful defecation, cramping, bloating and flatulence. Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to the onset of constipation. One way to reduce constipation through nutritional management of affected individuals is through consumption of probiotic products, which beneficially affect the development of microbial flora in the intestine, helping to improve the symptoms of constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis, which according to its maker, when consumed as part of a healthy diet, presents beneficial effects in improving symptoms of constipation.

Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms constipation.


Condition Intervention
Constipation
Dietary Supplement: Probiotic fresh cheese
Dietary Supplement: Regular Cheese

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Official Title: Effect of the Consumption of a Cheese Enriched With Probiotic Organisms (Bifidobacterium Lactis Bi-07) in Improving Symptoms of Constipation: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Centro Universitário Univates:

Primary Outcome Measures:
  • Increase in frequency of bowel movements after eating probiotic cheese enriched [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Probiotic cheese
The group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07.
Dietary Supplement: Probiotic fresh cheese
Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.
Other Name: Fresh cheese enriched with Bifidobacterium lactis Bi-07
Placebo Comparator: Regular Cheese
The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese.
Dietary Supplement: Regular Cheese

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • adults constipated.

Exclusion Criteria:

  • Pregnant women
  • Individuals who report to be suffering from other diseases of the intestine;
  • Individuals who report not eat cheese, either for reasons of taste or intolerances / food allergies
  • Individuals who do not agree to participate and do not sign the term of informed consent
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01680432

Locations
Brazil
Diane Cássia Fravetto
Guaporé, RS, Brazil, 95900000
Sponsors and Collaborators
Centro Universitário Univates
Investigators
Principal Investigator: Thaís R Moreira University Center Univates
  More Information

No publications provided

Responsible Party: Thaís Rodrigues Moreira, Professor, Centro Universitário Univates
ClinicalTrials.gov Identifier: NCT01680432     History of Changes
Other Study ID Numbers: 033/11
Study First Received: August 6, 2012
Last Updated: September 6, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Centro Universitário Univates:
constipation
probiotics
bifidobacterium
cheese

Additional relevant MeSH terms:
Constipation
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014