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

  Hide Detailed Description

Detailed Description:

General Objective: To investigate the effect of consumption of fresh cheese enriched with Bifidobacterium lactis in improving symptoms of constipation.

Specific Objectives:

Determine whether the intake of cheese enriched with Bifidobacterium lactis changes:

  • frequency of bowel movements;
  • straining or pain when defecating;
  • format of the faeces;
  • sensation of incomplete evacuation;
  • sensation of anorectal obstruction and
  • use of manual maneuvers to facilitate evacuation.

The food industry is increasingly concerned about produce food that are healthy and able to prevent diseases, in particular, to ensure intestinal health. To verify the effectiveness of these new products on the market is one way to ensure that they have health benefits. Thus, they may be indicated as a treatment for constipation, as part of a healthy lifestyle that includes nutrition and physical activity practice. For this reason, this search is justified.

Type Search:

The research is quantitative, exploratory and experimental. This is a clinical trial randomized and controlled trial.

Population and study sample:

The study population comprised of individuals who will use the Unified Service Health System, the Family Health Strategy,Brazil, participating groups of Nutritional Education. This population is comprised of approximately seventy individuals, but this number is quite relative, it depends on the participation. The approach of research subjects will be done through an invitation, conducted orally through the Community Health Agents (CHA), during home visits monthly. During the period of one month, the CHA invite to attend a lecture given by the student Diane Favretto, who will speak constipation on the subject and propose the participation of stake holders in the research. The stakeholders respond to a questionnaire administered by the student and those who 24 showing symptoms of constipation (according to Rome III criteria), will be part of study, and the sample.

Methodology:

For individuals in the population are classified as constipated, they will responding to a structured questionnaire with closed questions based on criteria Rome III that characterizes the symptoms of constipation. Will be considered constipated individual who has at least two of six symptoms in the questionnaire, 25 at least 25% of the evacuation, in that alternative corresponds to the questionnaire "Often".

Being able to participate in this study, a structured questionnaire, with open and closed questions to assess the lifestyle (dietary habits, intake of net) associated diseases and medications will be made to collect these data.

The weight of the participant will be measured using portable scale brand and the individual is placed standing bare foot in the center of scale with light clothing, with arms out stretched to the side, with out moving. To measure the height measuring tape will be set at flat wall with no baseboard and individuals will be placed in an upright position, standing with bare feet parallel and heels, shoulders and buttocks touching the wall. The Body Mass Index is calculated from data on weight and height (kg / m²) and classified according to the Organization World Health Organization.

Both data will be collected at the neighborhood community hall, where the meetings monthly nutrition education groups are held. Agreeing to participate in the study, the group will receive all necessary instructions and will sign the informed consent. Each participant receives two copies of the word, anda copy shall be given to the student and a copy will be with the participant. Individuals selected to participate in the study will be randomized into two groups: treated group and control group. The treatment group will receive the fresh cheese plus Bifidobacterium lactis Bi-07, with 108 colony forming units per serving. In the placebo group, individuals will receive a fresh cheese, the same brand, with out the addition of probiotics. The products will be packaged or numbered so that neither the researcher nor the participants know what is cheese and what is probiotic cheese placebo. The two groups will be oriented eating a slice of cheese per day (30 grams) for 30 days. This cheese will part of the breakfast. Patients will be advised that, according to the manufacturer's product, both cheeses not present any risk to health. Some patients may not like the taste of cheese. That may be minimized by the use there of in food preparation involving other,as sandwiches and salads, as long as the cheese is not heated, because this way he loses probiotic your property. During this period, all participants will be instructed to continue their normal dietary habits, physical activity and fluid intake. It will also be directed to participants do not make use of other products containing probiotics.

After the intervention period, the questionnaire on the symptoms of constipation is applied again in order to determine whe ther there was a change in bowel habits.

  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 August 28, 2014