<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/NCT04441359</url>
  </required_header>
  <id_info>
    <org_study_id>Study protocol June 2008 final</org_study_id>
    <nct_id>NCT04441359</nct_id>
  </id_info>
  <brief_title>Long-term Safety and Efficacy of Prebiotic Enriched Infant Formula</brief_title>
  <official_title>Effects of the Supplementation With Oligosaccharides on the Prevention of Infections in Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beneo-Institute</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratorios Ordesa</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>European Union</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Beneo-Institute</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 primary objective of the present study was to evaluate the effects of long-term&#xD;
      supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides&#xD;
      on immunological-health related outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study primarily aimed to evaluate the effects of long-term supplementation of an infant&#xD;
      formula with a mixture of short and long chain inulin-type oligosaccharides on&#xD;
      immunological-health related outcomes, as well as on gastrointestinal function and well-being&#xD;
      in infants during the first year of life. Effects on infant growth, tolerance and on the&#xD;
      composition of fecal microbiota were further objectives of this study. The study was&#xD;
      conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy&#xD;
      term infants. The two groups of the study are product group (standard infant formula&#xD;
      supplemented with inulin-type fructans) and control group (non-supplemented standard infant&#xD;
      formula).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2008</start_date>
  <completion_date type="Actual">October 31, 2010</completion_date>
  <primary_completion_date type="Actual">October 31, 2010</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>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of infections during first year of life</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>measured through presence of fever, and number and duration of infectious episodes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stool frequency</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stool consistency</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Digestive tolerance</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Growth</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body weight</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Body height</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessment of height (cm) in supine position by using a standard measuring board at all study visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Head circumference</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sleeping habits</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Crying episodes</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on fecal microbiota composition</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Quantification of dominant bacterial groups</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on development of allergy</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Effect on immunology markers in feces</measure>
    <time_frame>until infant reaches age of 1 year</time_frame>
    <description>secretory immunoglobulin A, calprotectin level</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Infection</condition>
  <condition>Microbial Colonization</condition>
  <condition>Healthy</condition>
  <arm_group>
    <arm_group_label>supplemented formula</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Standard formula supplemented with prebiotic inulin-type fructans</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard formula</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Standard Formula not supplemented with prebiotic inulin-type fructans</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Supplemented formula</intervention_name>
    <description>standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans</description>
    <arm_group_label>supplemented formula</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard formula</intervention_name>
    <description>standard infant formula not supplemented with prebiotic inulin-type fructans</description>
    <arm_group_label>standard formula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy babies born between 37 - 42 weeks of gestation and with weight appropriate for&#xD;
             gestational age (between percentiles 3 and 97)&#xD;
&#xD;
          -  Healthy babies aged between 0 - 4 months of age&#xD;
&#xD;
          -  Babies exclusively fed with an infant formula on enrolment into the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The presence of an infection at the moment of the recruitment or 1 week before&#xD;
             recruitment&#xD;
&#xD;
          -  The presence of important pathologies (intestinal, cardiopathy, mental retardation,&#xD;
             etc.)&#xD;
&#xD;
          -  Any other diseases related to the immune system (primary immunodeficiency)&#xD;
&#xD;
          -  Parents not able to comply with the study follow up (according to physician criteria)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>4 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>ZNA Koningin Paola Kinderziekenhuis</name>
      <address>
        <city>Antwerp</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Ziekenhuis</name>
      <address>
        <city>Brussel</city>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAP Llefià</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital de Nens</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Deu</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital San Cecilio</name>
      <address>
        <city>Granada</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Equipo Pediátrico San Francisco</name>
      <address>
        <city>Madrid</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.</citation>
  </results_reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 18, 2020</last_update_submitted>
  <last_update_submitted_qc>June 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04441359
org study id: Study protocol June 2008 final
nct id: NCT04441359
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The primary objective of the present study was to evaluate the effects of long-term
      supplementation of an infant formula supplemented with prebiotic inulin-type oligosaccharides
      on immunological-health related outcomes.
The study primarily aimed to evaluate the effects of long-term supplementation of an infant
      formula with a mixture of short and long chain inulin-type oligosaccharides on
      immunological-health related outcomes, as well as on gastrointestinal function and well-being
      in infants during the first year of life. Effects on infant growth, tolerance and on the
      composition of fecal microbiota were further objectives of this study. The study was
      conducted as a multicenter, randomised, double-blind, placebo-controlled study in healthy
      term infants. The two groups of the study are product group (standard infant formula
      supplemented with inulin-type fructans) and control group (non-supplemented standard infant
      formula).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Incidence of infections during first year of life
time frame: until infant reaches age of 1 year
description: measured through presence of fever, and number and duration of infectious episodes
measure: Stool frequency
time frame: until infant reaches age of 1 year
description: Number of depositions per day assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
measure: Stool consistency
time frame: until infant reaches age of 1 year
description: Assessed via 1-3 scale with pictograms (1=hard, 2=soft/formed, 3=liquid/semi-liquid), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
measure: Digestive tolerance
time frame: until infant reaches age of 1 year
description: Number of vomiting and regurgitation episodes per day and presence of excessive flatulence and infantile colic, assessed by parenteral reporting (parent's diary collected during first week of each study month throughout all study period)
measure: Growth
time frame: until infant reaches age of 1 year
description: Calculation of z-scores of weight-for-age and length-for-age according to the World Health Organisation (WHO) standards using WHO software (WHO Antro software).
measure: Body weight
time frame: until infant reaches age of 1 year
description: Assessment of weight (kg) of the nude infant via calibrated electronic scales at all study visits.
measure: Body height
time frame: until infant reaches age of 1 year
description: Assessment of height (cm) in supine position by using a standard measuring board at all study visits.
measure: Head circumference
time frame: until infant reaches age of 1 year
description: Assessment of head circumference (cm) using a non-extendable insertion tape at all study visits.
measure: Sleeping habits
time frame: until infant reaches age of 1 year
description: Assessment of total hours slept and total hours of nocturnal sleeping per day (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
measure: Crying episodes
time frame: until infant reaches age of 1 year
description: Assessment of crying episodes (min), by parenteral reporting (parent's diary collected during first week of each study month throughout all study period).
measure: Effect on fecal microbiota composition
time frame: until infant reaches age of 1 year
description: Quantification of dominant bacterial groups
measure: Effect on development of allergy
time frame: until infant reaches age of 1 year
description: Presence of clinical symptoms compatible with food allergies, atopic dermatitis, exanthema
measure: Effect on immunology markers in feces
time frame: until infant reaches age of 1 year
description: secretory immunoglobulin A, calprotectin level
arm group label: supplemented formula
arm group type: Experimental
description: Standard formula supplemented with prebiotic inulin-type fructans
arm group label: standard formula
arm group type: Placebo Comparator
description: Standard Formula not supplemented with prebiotic inulin-type fructans
intervention type: Other
intervention name: Supplemented formula
description: standard infant formula supplemented with 8 g/L prebiotic inulin-type fructans
arm group label: supplemented formula
intervention type: Other
intervention name: Standard formula
description: standard infant formula not supplemented with prebiotic inulin-type fructans
arm group label: standard formula
criteria: 
gender: All
minimum age: 1 Day
maximum age: 4 Months
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Spain
citation: Rodriguez-Palmero, M.; Campoy, C.; Urraca, O.; Alonso, J.; Maldonado, J.; Varea, V.; Palencia, J.; Veereman-Wauters, G.; Neumer, F.; Rivero, M.; Vandenplas, Y. Effects of long-term supplementation with a mixture of short and long chain inulin-type oligosaccharides (2013), Annals of Nutrition and Metabolism, suppl. 1, (63), 1-1960.
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: No