<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/NCT02247102</url>
  </required_header>
  <id_info>
    <org_study_id>TASMC-14-NV-132-CTIL</org_study_id>
    <nct_id>NCT02247102</nct_id>
  </id_info>
  <brief_title>Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants</brief_title>
  <official_title>Placebo-controlled Randomized Trial to Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose (Palatinose™) or Sucrose in Infants Aged 6-12 Months</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tel-Aviv Sourasky Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Beneo GmbH</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tel-Aviv Sourasky Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study shall investigate whether isomaltulose&#xD;
&#xD;
        -  is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as&#xD;
           ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the&#xD;
           postprandial period&#xD;
&#xD;
        -  does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated as&#xD;
           other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.&#xD;
&#xD;
      It is hypothesized that isomaltulose, provided with a standard follow-on formula,&#xD;
&#xD;
        1. will not significantly increase the mean basal breath H2-excretion rate (determined as&#xD;
           the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial&#xD;
           period compared to a sucrose containing standard follow-on formula.&#xD;
&#xD;
        2. will not lead to a significantly different gastrointestinal tolerance in the conse-quent&#xD;
           24 h after formula consumption compared to a sucrose containing standard follow-on&#xD;
           formula in infants aged 6 to 12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intervention will be scheduled on Study Day 1 and Study Day 2. The caretakers will be&#xD;
      asked to feed their infant with their usual standard formula in the morning of Study Day 1&#xD;
      and Study Day 2 at home (at their regular feeding time). At the study center, the infant will&#xD;
      consume his usual follow-up formula in the usual amount to wich the study product (palatinose&#xD;
      or sucrose 1 gram/kg body weight) will be added to the nearest 0.5 kg weight. The&#xD;
      introduction will be in the second meal of the day and the time between the first feeding and&#xD;
      the interventionwill be of 4h. Before and after the single consumption of the study formula&#xD;
      (baseline vs. test condition), the H2 exhalation of the infant will be measured and monitored&#xD;
      every 30 min for an additional period of 3 h. In between Study Days 1 and 2, a wash-out&#xD;
      period of at least 2 days will be implemented to reduce the potential occurrence of&#xD;
      carry-over effects.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">February 2015</primary_completion_date>
  <phase>Phase 3</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>hydrogen breath</measure>
    <time_frame>3 hours</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Malabsorption</condition>
  <arm_group>
    <arm_group_label>Isomaltulose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sucrose</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Isomaltulose</intervention_name>
    <description>Each subject receives isomaltulose on Study Day 1. After having completed the wash-out period, each subject receives sucrose on Study Day 2.&#xD;
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg).</description>
    <arm_group_label>Isomaltulose</arm_group_label>
    <arm_group_label>Sucrose</arm_group_label>
    <other_name>Palatinose™</other_name>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Sucrose</intervention_name>
    <description>Each subject receives sucrose on Study Day 1. After having completed the wash-out period, each subject receives isomaltulose on Study Day 2.&#xD;
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg).</description>
    <arm_group_label>Isomaltulose</arm_group_label>
    <arm_group_label>Sucrose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject was healthy-born at term (37th-42th gestational week) and is healthy at the&#xD;
             time of pre-examination&#xD;
&#xD;
          2. Subject is aged 6-12 months at the time of pre-examination&#xD;
&#xD;
          3. Subject ranges between 5th and 95th percentile for age (EURO Growth Guide-lines)&#xD;
&#xD;
          4. Subject has been formula-fed (and complementary food, such as fruit or car-rots, have&#xD;
             already been introduced) and not exclusively breast-fed for at least 4 weeks prior&#xD;
             onset of the trial&#xD;
&#xD;
          5. Parents/caretakers understand the English or Hebrew language and are able and willing&#xD;
             to follow the study instructions and fill out questionnaires&#xD;
&#xD;
          6. Subject is suitable for participation in the study according to the PI/study&#xD;
             per-sonnel&#xD;
&#xD;
          7. Parents/caretakers have voluntarily agreed to participate and successfully completed&#xD;
             the informed consent form (ICF)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subject is a pre-term (&lt;37th gestational week)&#xD;
&#xD;
          2. Subject or mother is suffering from an acute or chronic disease followed by medication&#xD;
             therapy at the time of pre-examination&#xD;
&#xD;
          3. Subject is suffering from (congenital) gastrointestinal disease or malformation&#xD;
             (followed by medication)&#xD;
&#xD;
          4. Subject is suffering/ suffered from infection (which lead to diarrhoea or vomit-ing)&#xD;
             in previous 14 days&#xD;
&#xD;
          5. Subject has been administered antibiotics and/or laxatives in the previous 14 days&#xD;
             prior to the start of the intervention&#xD;
&#xD;
          6. Subject has a (hereditary) fructose/lactose intolerance and/or (food) allergy&#xD;
&#xD;
          7. Subject is suffering from carbohydrate malabsorption&#xD;
&#xD;
          8. Drug or alcohol abuse by mother of subject&#xD;
&#xD;
          9. Subject is a hydrogen non producer.&#xD;
&#xD;
         10. Subject is currently involved or will be involved in another clinical or food study&#xD;
&#xD;
         11. Subject is not suitable for participation in the study according to the PI/study&#xD;
             personnel&#xD;
&#xD;
         12. It is impossible for the subject to travel to the study center on Study Days 1 and 2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Months</minimum_age>
    <maximum_age>12 Months</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nachum Vaisman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Tel Aviv Sourasky Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nachum Vaisman, MD</last_name>
    <phone>+972.524.266.596</phone>
    <email>nachumv@tlvmc.gov.il</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carolin Sieland</last_name>
    <phone>+49 6359 803 831</phone>
    <email>Carolin.Sieland@beneo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The Tel Aviv Sourasky Medical Center</name>
      <address>
        <city>Tel Aviv</city>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>December 2014</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>September 19, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 23, 2014</study_first_posted>
  <last_update_submitted>December 24, 2014</last_update_submitted>
  <last_update_submitted_qc>December 24, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 25, 2014</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>Malabsorption Syndromes</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/NCT02247102
org study id: TASMC-14-NV-132-CTIL
nct id: NCT02247102
lead sponsor: 
collaborator: 
has dmc: No
The study shall investigate whether isomaltulose

        -  is digested and absorbed to a comparable degree like other carbohydrates (CHO) used as
           ingredients for this age group (e.g. sucrose), by measuring the H2 exhalation in the
           postprandial period

        -  does not mediate abdominal discomfort or diarrhoea and is therefore as well tolerated as
           other CHO (e.g. sucrose), by/in healthy infants aged 6 to 12 months.

      It is hypothesized that isomaltulose, provided with a standard follow-on formula,

        1. will not significantly increase the mean basal breath H2-excretion rate (determined as
           the incremental area under the curve (iAUC) of H2-exhalation) over a 3 h postprandial
           period compared to a sucrose containing standard follow-on formula.

        2. will not lead to a significantly different gastrointestinal tolerance in the conse-quent
           24 h after formula consumption compared to a sucrose containing standard follow-on
           formula in infants aged 6 to 12 months.
The intervention will be scheduled on Study Day 1 and Study Day 2. The caretakers will be
      asked to feed their infant with their usual standard formula in the morning of Study Day 1
      and Study Day 2 at home (at their regular feeding time). At the study center, the infant will
      consume his usual follow-up formula in the usual amount to wich the study product (palatinose
      or sucrose 1 gram/kg body weight) will be added to the nearest 0.5 kg weight. The
      introduction will be in the second meal of the day and the time between the first feeding and
      the interventionwill be of 4h. Before and after the single consumption of the study formula
      (baseline vs. test condition), the H2 exhalation of the infant will be measured and monitored
      every 30 min for an additional period of 3 h. In between Study Days 1 and 2, a wash-out
      period of at least 2 days will be implemented to reduce the potential occurrence of
      carry-over effects.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: Triple (Participant, Care Provider, Investigator)
measure: hydrogen breath
time frame: 3 hours
arm group label: Isomaltulose
arm group type: Experimental
description: Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
arm group label: Sucrose
arm group type: Active Comparator
description: Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
intervention type: Dietary Supplement
intervention name: Isomaltulose
description: Each subject receives isomaltulose on Study Day 1. After having completed the wash-out period, each subject receives sucrose on Study Day 2.
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg).
arm group label: Isomaltulose
arm group label: Sucrose
other name: Palatinose™
intervention type: Dietary Supplement
intervention name: Sucrose
description: Each subject receives sucrose on Study Day 1. After having completed the wash-out period, each subject receives isomaltulose on Study Day 2.
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg).
arm group label: Isomaltulose
arm group label: Sucrose
criteria: 
gender: All
minimum age: 6 Months
maximum age: 12 Months
healthy volunteers: Accepts Healthy Volunteers
last name: Nachum Vaisman, MD
role: Principal Investigator
affiliation: The Tel Aviv Sourasky Medical Center
last name: Nachum Vaisman, MD
phone: +972.524.266.596
email: nachumv@tlvmc.gov.il
last name: Carolin Sieland
phone: +49 6359 803 831
email: Carolin.Sieland@beneo.com
facility: 
status: Recruiting
country: Israel
responsible party type: Sponsor
mesh term: Malabsorption Syndromes