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

NCT01680432 | Completed DMC

• 1 other identifier: 033/11
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Constipation

Keywords

constipation; probiotics; bifidobacterium; cheese

Outcome Measures

Primary Outcomes (1)

• Increase in frequency of bowel movements after eating probiotic cheese enriched

  1 month

Study Arms (2)

Probiotic cheese

EXPERIMENTAL

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

Regular Cheese

PLACEBO COMPARATOR

The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese.

Dietary Supplement: Regular Cheese

Interventions

Probiotic fresh cheese DIETARY_SUPPLEMENT

Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.

Also known as: Fresh cheese enriched with Bifidobacterium lactis Bi-07

Probiotic cheese

Regular Cheese DIETARY_SUPPLEMENT

Regular Cheese

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• adults constipated.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centro Universitário Univates: lead

Study Sites (1)

Diane Cássia Fravetto

Guaporé, Rio Grande do Sul, 95900000, Brazil

Location

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

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

Study Officials

• Thaís R Moreira

  University Center Univates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 6, 2012
• First Posted: September 7, 2012
• Study Start: January 1, 2012
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: September 7, 2012

Record last verified: 2012-09

Locations

BR (1)