<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/NCT04506801</url>
  </required_header>
  <id_info>
    <org_study_id>380-130/134-19-4</org_study_id>
    <nct_id>NCT04506801</nct_id>
  </id_info>
  <brief_title>The Effect of Probiotics on Functional Constipation in the Elderly</brief_title>
  <official_title>The Effect of Probiotics on Functional Constipation in the Elderly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Katarina Fehir Šola</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Zagreb</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main scope of the proposed research in the framework is to investigate the effect of&#xD;
      probiotic bacteria Lactobacillus acidophilus LA3, Bifidobacterium animalis ssp. lactis BLC1 i&#xD;
      Lactobacillus casei BGP93 on functional constipation and on the quality of life of the&#xD;
      elderly in a nursing home. The experimental part will consists of double-blind,&#xD;
      placebo-controlled clinical trial over 12 weeks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      During the first four weeks, the subjects were monitored primarily concerning bowel&#xD;
      discharges and general health. After that initial four weeks, they are re-evaluated&#xD;
      compliance with inclusion and exclusion criteria. Participants were allocated to the&#xD;
      double-blind section of the trial (12 weeks), using o computer-generated to a placebo group&#xD;
      or in the probiotic group in the form of a liquid oral formulation once a day. On first day&#xD;
      of intervention participants provide a blood sample. All investigators, participants and&#xD;
      study personnel were blinded to the order of randomization. Participants were told to consume&#xD;
      9 drops of study probiotics once a day for next 12-week intervention. On last day of&#xD;
      intervention, participants provide a blood sample. The last four weeks of the double-blind&#xD;
      section (week 9-12) participants an evaluation period in which the respondents were evaluated&#xD;
      for the outcomes of the study. After completing the double-blind study, the participants were&#xD;
      followed for an additional four weeks. Inclusive / Excluded criteria are evaluated on two&#xD;
      occasions, at the time of inclusion in the 4-week introductory section and its end.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 25, 2018</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">March 25, 2019</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>Parallel Assignment</intervention_model>
    <intervention_model_description>randomised double-blind study</intervention_model_description>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>Single (Care Provider)</masking>
    <masking_description>A randomization list will be generated by the permutated block method (variable size 4-6) and will be kept in a sealed envelope by a person not included in the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in stool frequency in patients who use probiotics</measure>
    <time_frame>12 weeks</time_frame>
    <description>The proportion of subjects who meet the criterion of &quot;normal bowel movement&quot; according to the Roman IV criteria, at least 3 times a week to no more than 3 times a day. This proportion will be determined for each of the 4 evaluation weeks and will be analyzed as a time-averaged proportion. The proportion will be estimated on the basis of the subjects' diaries in which, by days, with indicated dates, the subjects will record each bowel emptying. Investigators would inform the evidence base with regards to the multi-strained probiotic efficacy in treating constipation among the elderly.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method</measure>
    <time_frame>12 weeks</time_frame>
    <description>The secondary outcome is to investigate the effect of selected probiotic strains on the concentration of the marker of inflammation, hs c-reactive protein (hs-CRP) in the serum of the subjects. hs-CRP will be determined by the immunoturbidimetric method. Investigators wanted to study the effect of this multi-strained probiotic on clinical and laboratory parameters. Blood was collected before the probiotic intervention and after 12 weeks.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods</measure>
    <time_frame>12 weeks</time_frame>
    <description>Values of laboratory indicators - glucose metabolism will be monitored. Investigators wanted to study the effect of this multi-strained probiotic on glucose parameters. Blood was collected like in Outcome2, before the intervention and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.</measure>
    <time_frame>12 weeks</time_frame>
    <description>Values of laboratory indicators of lipid metabolism - triglycerides will be monitored. Blood was collected before and after the intervention. Investigators wanted to study the effect of multi-strain probiotics on triglycerides.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigator monitoring change of laboratory indicators of total cholesterol in beginning and at the end of the intervention with multi-strain probiotics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods</measure>
    <time_frame>12 weeks</time_frame>
    <description>Values of laboratory indicators of HDL (high density lipoprotein) will be monitoring during the intervention. Blood samples were collected before and after the intervention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods</measure>
    <time_frame>12 weeks</time_frame>
    <description>Investigator monitoring change of laboratory indicators of LDL(low density lipoprotein), before study and at the end of the intervention.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Functional Constipation</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>liquid oral formulation 9 drops once a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Probiotic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The probiotic contained Lactobacillus acidophilus LA3; 1 · 1011 CFU / g, Bifidobacterium animalis subsp. Lactis BLC1; 1.5 · 1011 CFU / g and Lactobacillus casei BGP93 2 · 1011cfu / g in the form of a liquid oral formulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Probalans senior</intervention_name>
    <description>Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.</description>
    <arm_group_label>Probiotic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 65 years or more&#xD;
&#xD;
          -  signed informed consent for study participation&#xD;
&#xD;
          -  functional constipation defined by Rome IV criteria&#xD;
&#xD;
          -  ability to understand the procedure&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspicion of obstructive ileus or previous obstructive ileus&#xD;
&#xD;
          -  suspected or confirmed diagnosis: irritable colon syndrome, ulcerative colitis,&#xD;
             Crohn's disease, malignant digestive tract disease&#xD;
&#xD;
          -  diarrhoea of any cause within the last month&#xD;
&#xD;
          -  acute infectious disease within the last month excluding people who use antibiotics&#xD;
&#xD;
          -  persons who have opioid analgesics in pharmacotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Katarina Fehir Šola</name>
      <address>
        <city>Bjelovar</city>
        <zip>43000</zip>
        <country>Croatia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Croatia</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 29, 2020</study_first_submitted>
  <study_first_submitted_qc>August 6, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 6, 2020</last_update_submitted>
  <last_update_submitted_qc>August 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Zagreb</investigator_affiliation>
    <investigator_full_name>Katarina Fehir Šola</investigator_full_name>
    <investigator_title>Director of pharmacy</investigator_title>
  </responsible_party>
  <keyword>constipation</keyword>
  <keyword>elderly</keyword>
  <keyword>probiotics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
  </patient_data>
  <!-- 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/NCT04506801
org study id: 380-130/134-19-4
nct id: NCT04506801
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main scope of the proposed research in the framework is to investigate the effect of
      probiotic bacteria Lactobacillus acidophilus LA3, Bifidobacterium animalis ssp. lactis BLC1 i
      Lactobacillus casei BGP93 on functional constipation and on the quality of life of the
      elderly in a nursing home. The experimental part will consists of double-blind,
      placebo-controlled clinical trial over 12 weeks.
During the first four weeks, the subjects were monitored primarily concerning bowel
      discharges and general health. After that initial four weeks, they are re-evaluated
      compliance with inclusion and exclusion criteria. Participants were allocated to the
      double-blind section of the trial (12 weeks), using o computer-generated to a placebo group
      or in the probiotic group in the form of a liquid oral formulation once a day. On first day
      of intervention participants provide a blood sample. All investigators, participants and
      study personnel were blinded to the order of randomization. Participants were told to consume
      9 drops of study probiotics once a day for next 12-week intervention. On last day of
      intervention, participants provide a blood sample. The last four weeks of the double-blind
      section (week 9-12) participants an evaluation period in which the respondents were evaluated
      for the outcomes of the study. After completing the double-blind study, the participants were
      followed for an additional four weeks. Inclusive / Excluded criteria are evaluated on two
      occasions, at the time of inclusion in the 4-week introductory section and its end.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: randomised double-blind study
primary purpose: Health Services Research
masking: Single (Care Provider)
masking description: A randomization list will be generated by the permutated block method (variable size 4-6) and will be kept in a sealed envelope by a person not included in the study.
measure: Change in stool frequency in patients who use probiotics
time frame: 12 weeks
description: The proportion of subjects who meet the criterion of "normal bowel movement" according to the Roman IV criteria, at least 3 times a week to no more than 3 times a day. This proportion will be determined for each of the 4 evaluation weeks and will be analyzed as a time-averaged proportion. The proportion will be estimated on the basis of the subjects' diaries in which, by days, with indicated dates, the subjects will record each bowel emptying. Investigators would inform the evidence base with regards to the multi-strained probiotic efficacy in treating constipation among the elderly.
measure: Change in hs-CRP at the blood of a patient who uses probiotics determined by immunoturbidimetric method
time frame: 12 weeks
description: The secondary outcome is to investigate the effect of selected probiotic strains on the concentration of the marker of inflammation, hs c-reactive protein (hs-CRP) in the serum of the subjects. hs-CRP will be determined by the immunoturbidimetric method. Investigators wanted to study the effect of this multi-strained probiotic on clinical and laboratory parameters. Blood was collected before the probiotic intervention and after 12 weeks.
measure: Change in glucose parameters of a patient who use probiotics determined by standard laboratory methods
time frame: 12 weeks
description: Values of laboratory indicators - glucose metabolism will be monitored. Investigators wanted to study the effect of this multi-strained probiotic on glucose parameters. Blood was collected like in Outcome2, before the intervention and after the intervention.
measure: Change in blood parameters- triglycerides of a patient who use probiotics determined by standard laboratory methods.
time frame: 12 weeks
description: Values of laboratory indicators of lipid metabolism - triglycerides will be monitored. Blood was collected before and after the intervention. Investigators wanted to study the effect of multi-strain probiotics on triglycerides.
measure: Change in blood parameter- total cholesterol of a patient determined by standard laboratory methods
time frame: 12 weeks
description: Investigator monitoring change of laboratory indicators of total cholesterol in beginning and at the end of the intervention with multi-strain probiotics.
measure: Change in HDL cholesterol in blood parameters of a patient who use probiotics determined by standard laboratory methods
time frame: 12 weeks
description: Values of laboratory indicators of HDL (high density lipoprotein) will be monitoring during the intervention. Blood samples were collected before and after the intervention.
measure: Change in LDL cholesterol at the blood of patients who use probiotics determined by standard laboratory methods
time frame: 12 weeks
description: Investigator monitoring change of laboratory indicators of LDL(low density lipoprotein), before study and at the end of the intervention.
arm group label: Placebo
arm group type: Placebo Comparator
description: liquid oral formulation 9 drops once a day
arm group label: Probiotic
arm group type: Experimental
description: The probiotic contained Lactobacillus acidophilus LA3; 1 · 1011 CFU / g, Bifidobacterium animalis subsp. Lactis BLC1; 1.5 · 1011 CFU / g and Lactobacillus casei BGP93 2 · 1011cfu / g in the form of a liquid oral formulation
intervention type: Dietary Supplement
intervention name: Probalans senior
description: Participants were told to consume 9 drops of study probiotics/placebo once a day for next 12-week intervention.
arm group label: Probiotic
intervention type: Other
intervention name: Placebo
description: Participants were told to consume 9 drops of study placebo one a day for the next 12-week intervention
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Croatia
responsible party type: Sponsor-Investigator
investigator affiliation: University of Zagreb
investigator full name: Katarina Fehir Šola
investigator title: Director of pharmacy
mesh term: Constipation
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication