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

September 6, 2012 updated by: Thaís Rodrigues Moreira, Centro Universitário Univates

Effect of the Consumption of a Cheese Enriched With Probiotic Organisms (Bifidobacterium Lactis Bi-07) in Improving Symptoms of Constipation: a Randomized Controlled Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • RS
      • Guaporé, RS, Brazil, 95900000
        • Diane Cássia Fravetto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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 Names:
  • 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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Increase in frequency of bowel movements after eating probiotic cheese enriched
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centro Universitário Univates

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Thaís R Moreira, University Center Univates

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 6, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 033/11

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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