<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01680432</url>
  </required_header>
  <id_info>
    <org_study_id>033/11</org_study_id>
    <nct_id>NCT01680432</nct_id>
  </id_info>
  <brief_title>Effect of the Consumption of a Cheese Enriched With Probiotic Organisms in Improving Symptoms of Constipation</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro Universitário Univates</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro Universitário Univates</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Constipation is a common gastrointestinal motility disorder, chronic condition that often&#xD;
      negatively affects the daily lives of patients due to their symptoms, such as infrequent&#xD;
      stools, hard stools, straining or painful defecation, cramping, bloating and flatulence.&#xD;
      Stress, poor diet and sedentary lifestyle are part of modern lifestyle, which contributes to&#xD;
      the onset of constipation. One way to reduce constipation through nutritional management of&#xD;
      affected individuals is through consumption of probiotic products, which beneficially affect&#xD;
      the development of microbial flora in the intestine, helping to improve the symptoms of&#xD;
      constipation. Among these foods, the market is a fresh cheese, plus Bifidobacterium lactis,&#xD;
      which according to its maker, when consumed as part of a healthy diet, presents beneficial&#xD;
      effects in improving symptoms of constipation.&#xD;
&#xD;
      Hypothesis: The fresh cheese enriched with Bifidobacterium lactis relieves symptoms&#xD;
      constipation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      General Objective: To investigate the effect of consumption of fresh cheese enriched with&#xD;
      Bifidobacterium lactis in improving symptoms of constipation.&#xD;
&#xD;
      Specific Objectives:&#xD;
&#xD;
      Determine whether the intake of cheese enriched with Bifidobacterium lactis changes:&#xD;
&#xD;
        -  frequency of bowel movements;&#xD;
&#xD;
        -  straining or pain when defecating;&#xD;
&#xD;
        -  format of the faeces;&#xD;
&#xD;
        -  sensation of incomplete evacuation;&#xD;
&#xD;
        -  sensation of anorectal obstruction and&#xD;
&#xD;
        -  use of manual maneuvers to facilitate evacuation.&#xD;
&#xD;
      The food industry is increasingly concerned about produce food that are healthy and able to&#xD;
      prevent diseases, in particular, to ensure intestinal health. To verify the effectiveness of&#xD;
      these new products on the market is one way to ensure that they have health benefits. Thus,&#xD;
      they may be indicated as a treatment for constipation, as part of a healthy lifestyle that&#xD;
      includes nutrition and physical activity practice. For this reason, this search is justified.&#xD;
&#xD;
      Type Search:&#xD;
&#xD;
      The research is quantitative, exploratory and experimental. This is a clinical trial&#xD;
      randomized and controlled trial.&#xD;
&#xD;
      Population and study sample:&#xD;
&#xD;
      The study population comprised of individuals who will use the Unified Service Health System,&#xD;
      the Family Health Strategy,Brazil, participating groups of Nutritional Education. This&#xD;
      population is comprised of approximately seventy individuals, but this number is quite&#xD;
      relative, it depends on the participation. The approach of research subjects will be done&#xD;
      through an invitation, conducted orally through the Community Health Agents (CHA), during&#xD;
      home visits monthly. During the period of one month, the CHA invite to attend a lecture given&#xD;
      by the student Diane Favretto, who will speak constipation on the subject and propose the&#xD;
      participation of stake holders in the research. The stakeholders respond to a questionnaire&#xD;
      administered by the student and those who 24 showing symptoms of constipation (according to&#xD;
      Rome III criteria), will be part of study, and the sample.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      For individuals in the population are classified as constipated, they will responding to a&#xD;
      structured questionnaire with closed questions based on criteria Rome III that characterizes&#xD;
      the symptoms of constipation. Will be considered constipated individual who has at least two&#xD;
      of six symptoms in the questionnaire, 25 at least 25% of the evacuation, in that alternative&#xD;
      corresponds to the questionnaire &quot;Often&quot;.&#xD;
&#xD;
      Being able to participate in this study, a structured questionnaire, with open and closed&#xD;
      questions to assess the lifestyle (dietary habits, intake of net) associated diseases and&#xD;
      medications will be made to collect these data.&#xD;
&#xD;
      The weight of the participant will be measured using portable scale brand and the individual&#xD;
      is placed standing bare foot in the center of scale with light clothing, with arms out&#xD;
      stretched to the side, with out moving. To measure the height measuring tape will be set at&#xD;
      flat wall with no baseboard and individuals will be placed in an upright position, standing&#xD;
      with bare feet parallel and heels, shoulders and buttocks touching the wall. The Body Mass&#xD;
      Index is calculated from data on weight and height (kg / m²) and classified according to the&#xD;
      Organization World Health Organization.&#xD;
&#xD;
      Both data will be collected at the neighborhood community hall, where the meetings monthly&#xD;
      nutrition education groups are held. Agreeing to participate in the study, the group will&#xD;
      receive all necessary instructions and will sign the informed consent. Each participant&#xD;
      receives two copies of the word, anda copy shall be given to the student and a copy will be&#xD;
      with the participant. Individuals selected to participate in the study will be randomized&#xD;
      into two groups: treated group and control group. The treatment group will receive the fresh&#xD;
      cheese plus Bifidobacterium lactis Bi-07, with 108 colony forming units per serving. In the&#xD;
      placebo group, individuals will receive a fresh cheese, the same brand, with out the addition&#xD;
      of probiotics. The products will be packaged or numbered so that neither the researcher nor&#xD;
      the participants know what is cheese and what is probiotic cheese placebo. The two groups&#xD;
      will be oriented eating a slice of cheese per day (30 grams) for 30 days. This cheese will&#xD;
      part of the breakfast. Patients will be advised that, according to the manufacturer's&#xD;
      product, both cheeses not present any risk to health. Some patients may not like the taste of&#xD;
      cheese. That may be minimized by the use there of in food preparation involving other,as&#xD;
      sandwiches and salads, as long as the cheese is not heated, because this way he loses&#xD;
      probiotic your property. During this period, all participants will be instructed to continue&#xD;
      their normal dietary habits, physical activity and fluid intake. It will also be directed to&#xD;
      participants do not make use of other products containing probiotics.&#xD;
&#xD;
      After the intervention period, the questionnaire on the symptoms of constipation is applied&#xD;
      again in order to determine whe ther there was a change in bowel habits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase in frequency of bowel movements after eating probiotic cheese enriched</measure>
    <time_frame>1 month</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Constipation</condition>
  <arm_group>
    <arm_group_label>Probiotic cheese</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Regular Cheese</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probiotic fresh cheese</intervention_name>
    <description>Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.</description>
    <arm_group_label>Probiotic cheese</arm_group_label>
    <other_name>Fresh cheese enriched with Bifidobacterium lactis Bi-07</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Regular Cheese</intervention_name>
    <arm_group_label>Regular Cheese</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults constipated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Individuals who report to be suffering from other diseases of the intestine;&#xD;
&#xD;
          -  Individuals who report not eat cheese, either for reasons of taste or intolerances /&#xD;
             food allergies&#xD;
&#xD;
          -  Individuals who do not agree to participate and do not sign the term of informed&#xD;
             consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thaís R Moreira</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Center Univates</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Diane Cássia Fravetto</name>
      <address>
        <city>Guaporé</city>
        <state>RS</state>
        <zip>95900000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>September 6, 2012</last_update_submitted>
  <last_update_submitted_qc>September 6, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro Universitário Univates</investigator_affiliation>
    <investigator_full_name>Thaís Rodrigues Moreira</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>constipation</keyword>
  <keyword>probiotics</keyword>
  <keyword>bifidobacterium</keyword>
  <keyword>cheese</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01680432
org study id: 033/11
nct id: NCT01680432
lead sponsor: 
has dmc: Yes
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.
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.
allocation: Randomized
intervention model: Crossover Assignment
masking: None (Open Label)
measure: Increase in frequency of bowel movements after eating probiotic cheese enriched
time frame: 1 month
arm group label: Probiotic cheese
arm group type: Experimental
description: The group received, for 30 days, was instructed to eat 30 g/day of probiotic fresh cheese enriched with Bifidobacterium lactis Bi-07.
arm group label: Regular Cheese
arm group type: Placebo Comparator
description: The group placebo received, for 30 days, was instructed to consume 30g/day of regular fresh cheese.
intervention type: Dietary Supplement
intervention name: Probiotic fresh cheese
description: Participants in the intervention group were instructed to drink 30 grams of fresh cheese enriched with probiotics daily for 30 consecutive days.
arm group label: Probiotic cheese
other name: Fresh cheese enriched with Bifidobacterium lactis Bi-07
intervention type: Dietary Supplement
intervention name: Regular Cheese
arm group label: Regular Cheese
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thaís R Moreira
role: Principal Investigator
affiliation: University Center Univates
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Centro Universitário Univates
investigator full name: Thaís Rodrigues Moreira
investigator title: Professor
mesh term: Constipation