<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/NCT04487834</url>
  </required_header>
  <id_info>
    <org_study_id>Kalisz 2020-01</org_study_id>
    <nct_id>NCT04487834</nct_id>
  </id_info>
  <brief_title>Effects of Multilac Baby on Crying Behavior of Colicky Babies</brief_title>
  <official_title>Effects of Simethicone and Multilac Baby in Infantile Colic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The President Stanisław Wojciechowski State University of Applied Sciences in Kalisz</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>
      Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby in&#xD;
      babies diagnosed for infantile colic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria.&#xD;
      Study design will be open label with two parallel arms (Simethicone and Multilac Baby).&#xD;
      Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3&#xD;
      bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental&#xD;
      24h paper diaries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 16, 2020</start_date>
  <completion_date type="Actual">June 30, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change of days of crying</measure>
    <time_frame>Three weeks</time_frame>
    <description>Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of average duration of evening crying</measure>
    <time_frame>Three weeks</time_frame>
    <description>Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change of average number of crying phases per day</measure>
    <time_frame>Three weeks</time_frame>
    <description>Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">87</enrollment>
  <condition>Infantile Colic</condition>
  <arm_group>
    <arm_group_label>Simethicone Solution</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Multilac Baby</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Simethicone Solution</intervention_name>
    <description>Oral daily treatment for four weeks</description>
    <arm_group_label>Simethicone Solution</arm_group_label>
    <other_name>Simethicone</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Multilac Baby</intervention_name>
    <description>Oral daily treatment for four weeks</description>
    <arm_group_label>Multilac Baby</arm_group_label>
    <other_name>Multistrain Synbiotic</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosed for infantile colic according to Wessel's criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous treatment with probiotic or synbiotic&#xD;
&#xD;
          -  previous treatment with antibiotics&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Weeks</minimum_age>
    <maximum_age>6 Weeks</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hanna Krauss, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Applied Sciences in Kalisz, Poland</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>GP Practice Pro Familia</name>
      <address>
        <city>Koziegłowy</city>
        <zip>62028</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical University in Poznań</name>
      <address>
        <city>Poznan</city>
        <zip>61701</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <link>
    <url>https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246756/</url>
    <description>In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters</description>
  </link>
  <reference>
    <citation>Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.</citation>
    <PMID>32403297</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 22, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 26, 2020</last_update_submitted>
  <last_update_submitted_qc>July 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colic</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Simethicone</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol: Effects of Simethicone and Multilac Baby in Infantile Colic</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04487834/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Annex Patient Assessment Sheet Day 0</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04487834/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Study Protocol: Annex 24 Hours Parental Diary Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04487834/Prot_002.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>March 2, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/34/NCT04487834/SAP_003.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>January 31, 2023</submitted>
  </pending_results>
  <!-- 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/NCT04487834
org study id: Kalisz 2020-01
nct id: NCT04487834
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Open trial with two parallel arms, assessing the effects of Simethicone and Multilac Baby in
      babies diagnosed for infantile colic.
Babies aged 3 to 6 weeks will be diagnosed for infantile colic using the Wessel's criteria.
      Study design will be open label with two parallel arms (Simethicone and Multilac Baby).
      Multilac Baby is a synbiotic product containing probiotic bacteria (six lactobacilli and 3
      bifidobacteria). Effects of treatments on crying behavior will be assessed by using parental
      24h paper diaries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change of days of crying
time frame: Three weeks
description: Measurement of days of crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
measure: Change of average duration of evening crying
time frame: Three weeks
description: Measurement of average duration of evening crying during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
measure: Change of average number of crying phases per day
time frame: Three weeks
description: Measurement average number of crying phases per day during last three weeks before enrollment and before the end of treatment. Treatment success was determined by calculation the percentage of patients for whom the measurement was reduced by the respective treatment by equal or more than 50 percent, compared to the value at the time of enrollment.
arm group label: Simethicone Solution
arm group type: Active Comparator
description: Treatment with simethicone (Espumisan®, 100 mg/ml, Berlin-Chemie / Menarini Polska Sp z o.o., Warsaw, Poland) for four weeks. Simethicone was administered 3-6 times per day with each treatment comprising 6 drops of the 100 mg/ml emulsion.
arm group label: Multilac Baby
arm group type: Experimental
description: Treatment with one stick pack of the multi-strain synbiotic (Multilac® Baby, Vivatrex GmbH, Aachen, Germany) per day for four weeks. Each stick pack of Multilac® Baby contains a total of 10^9 colony forming units (CFU) with equal CFU amounts of the following probiotic bacteria: L. acidophilus LA-14, L. casei R0215; L. paracasei Lpc-3; L. plantarum Lp-115; L. rhamnosus GG, L. salivarius Ls-33, B. lactis Bl-04, B. bifidum R0071, B. longum R0175 and 1.43 g of the prebiotic fructooligosaccharides.
intervention type: Drug
intervention name: Simethicone Solution
description: Oral daily treatment for four weeks
arm group label: Simethicone Solution
other name: Simethicone
intervention type: Dietary Supplement
intervention name: Multilac Baby
description: Oral daily treatment for four weeks
arm group label: Multilac Baby
other name: Multistrain Synbiotic
criteria: 
gender: All
minimum age: 3 Weeks
maximum age: 6 Weeks
healthy volunteers: No
last name: Hanna Krauss, Prof.
role: Principal Investigator
affiliation: University of Applied Sciences in Kalisz, Poland
facility: 
facility: 
country: Poland
url: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7246756/
description: In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters
citation: Piatek J, Krauss H, Ciechelska-Rybarczyk A, Bernatek M, Wojtyla-Buciora P, Sommermeyer H. In-Vitro Growth Inhibition of Bacterial Pathogens by Probiotics and a Synbiotic: Product Composition Matters. Int J Environ Res Public Health. 2020 May 11;17(9):3332. doi: 10.3390/ijerph17093332.
PMID: 32403297
responsible party type: Sponsor
mesh term: Colic
mesh term: Simethicone
sharing ipd: No
provided document: 
provided document: 
provided document: 
provided document: 
submitted: January 31, 2023