<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/NCT04462640</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A03340-57</org_study_id>
    <nct_id>NCT04462640</nct_id>
  </id_info>
  <brief_title>Management of Infant Digestive Disorders and Quality of Life</brief_title>
  <official_title>Management of Infant Digestive Disorders and Quality of Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Keyrus Biopharma</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Société des Produits Nestlé (SPN)</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of the study is to measure the evolution of the quality of life in infants&#xD;
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The objective of the study is to measure the evolution of the quality of life in infants&#xD;
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic,&#xD;
      following nutritional management of these disorders by a preparation for thickened infants,&#xD;
      reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of&#xD;
      life is assessed using the QUALIN questionnaire&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 28, 2020</start_date>
  <completion_date type="Actual">November 17, 2021</completion_date>
  <primary_completion_date type="Actual">November 17, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life in infants with regurgitation and colic</measure>
    <time_frame>4 months</time_frame>
    <description>The main endpoint will be an increase in the QUALIN (QUALIté de vie du Nourrison) score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only. This score is between -68 to +68. An increase in score means an improvement in symptoms.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Infant Nutrition Disorders</condition>
  <condition>Gastrointestinal Dysfunction</condition>
  <arm_group>
    <arm_group_label>regurgitation</arm_group_label>
    <description>45 infants aged 0 to 5 months suffering from regurgitation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>colic</arm_group_label>
    <description>45 infants aged 0 to 5 months suffering from colic</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Management of Infant Digestive Disorders and Quality of Life</intervention_name>
    <description>The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.</description>
    <arm_group_label>colic</arm_group_label>
    <arm_group_label>regurgitation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        infants between 0 and 5 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Full-term infants (&gt; 37 weeks gestation and &lt;42 weeks gestation), less than 4 months of age&#xD;
        at recruitment&#xD;
&#xD;
          -  Infants with regurgitation and / or colic defined according to Rome IV criteria&#xD;
&#xD;
          -  Non-breastfed infants&#xD;
&#xD;
          -  Parents who understand and speak French fluently&#xD;
&#xD;
          -  Parents agreeing to send their email address and having a computer tool (computer,&#xD;
             tablet or smartphone) allowing them to complete the QoL questionnaires and the&#xD;
             satisfaction questionnaire&#xD;
&#xD;
          -  Parents having understood the protocol and the information given and having given the&#xD;
             participation agreement including their acceptance to return for consultation with the&#xD;
             same doctor after a period of 30 days.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Infant born prematurely (&lt;37 weeks)&#xD;
&#xD;
        • Intercurrent pathology other than a functional intestinal disorder which can by&#xD;
        themselves cause, directly or as a result of treatments, a functional intestinal disorder:&#xD;
        Study Management of infant digestive disorders and Quality of life&#xD;
&#xD;
          -  Food allergy&#xD;
&#xD;
          -  Digestive pathology (Gastroenteritis, celiac disease, high or low digestive&#xD;
             malformations….)&#xD;
&#xD;
          -  Heart failure, cyanogenic heart disease&#xD;
&#xD;
          -  Chronic respiratory diseases (bronchopulmonary dysplasia, malformations, respiratory&#xD;
             failure)&#xD;
&#xD;
          -  Neurological pathologies (Cerebral palsy, intracranial hypertension, convulsive state)&#xD;
&#xD;
          -  Congenital metabolic pathologies&#xD;
&#xD;
          -  Genetic diseases&#xD;
&#xD;
          -  Kidney malformations, Vesicoureteral reflux, Kidney failure.&#xD;
&#xD;
          -  Drug treatment in progress and which will be continued during the study, other than&#xD;
             vitamins (D, K, ...)&#xD;
&#xD;
          -  Partial or total breastfeeding&#xD;
&#xD;
          -  Infants already fed:&#xD;
&#xD;
          -  with a hypoallergenic formula (HA)&#xD;
&#xD;
          -  or with a high hydrolyzate of cow's milk proteins or formula based on rice protein&#xD;
             hydrolyzate&#xD;
&#xD;
          -  Growth retardation (weight and or height less than or equal to - 2 DS) or break in the&#xD;
             weight curve (no weight gain or weight loss in the past month) Prescription of drugs&#xD;
             or food supplements other than vitamins at the end of the visit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Week</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sandra Brancato</name>
      <address>
        <city>Brignon</city>
        <zip>30190</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 2, 2020</study_first_submitted>
  <study_first_submitted_qc>July 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>August 25, 2022</last_update_submitted>
  <last_update_submitted_qc>August 25, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 26, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Quality of life</keyword>
  <keyword>Infants</keyword>
  <keyword>Regurgitation</keyword>
  <keyword>Colic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Digestive System Diseases</mesh_term>
    <mesh_term>Nutrition Disorders</mesh_term>
    <mesh_term>Infant Nutrition Disorders</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04462640
org study id: 2019-A03340-57
nct id: NCT04462640
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to measure the evolution of the quality of life in infants
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic.
The objective of the study is to measure the evolution of the quality of life in infants
      between 0 and 5 months old, not breastfed and suffering from regurgitation or colic,
      following nutritional management of these disorders by a preparation for thickened infants,
      reduced in lactose content and supplemented with Lactobacillus reuteri DSM 17938. Quality of
      life is assessed using the QUALIN questionnaire
observational model: Cohort
time perspective: Prospective
measure: Quality of life in infants with regurgitation and colic
time frame: 4 months
description: The main endpoint will be an increase in the QUALIN (QUALIté de vie du Nourrison) score on D30 compared to inclusion (D0) according to the 2 groups of patients: regurgitation only and colic only. This score is between -68 to +68. An increase in score means an improvement in symptoms.
arm group label: regurgitation
description: 45 infants aged 0 to 5 months suffering from regurgitation
arm group label: colic
description: 45 infants aged 0 to 5 months suffering from colic
intervention type: Other
intervention name: Management of Infant Digestive Disorders and Quality of Life
description: The variation of the QUALIN score on D30 compared to inclusion (D0) will be described and compared using a Student test for paired data in the case of a normal distribution or a test of the ranks signed by Wilcoxon otherwise.
arm group label: colic
arm group label: regurgitation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Week
maximum age: 4 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Digestive System Diseases
mesh term: Nutrition Disorders
mesh term: Infant Nutrition Disorders
sharing ipd: Undecided