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Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants

Primary Purpose

Malabsorption

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
Isomaltulose
Sucrose
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Malabsorption

Eligibility Criteria

6 Months - 12 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Subject was healthy-born at term (37th-42th gestational week) and is healthy at the time of pre-examination
  2. Subject is aged 6-12 months at the time of pre-examination
  3. Subject ranges between 5th and 95th percentile for age (EURO Growth Guide-lines)
  4. Subject has been formula-fed (and complementary food, such as fruit or car-rots, have already been introduced) and not exclusively breast-fed for at least 4 weeks prior onset of the trial
  5. Parents/caretakers understand the English or Hebrew language and are able and willing to follow the study instructions and fill out questionnaires
  6. Subject is suitable for participation in the study according to the PI/study per-sonnel
  7. Parents/caretakers have voluntarily agreed to participate and successfully completed the informed consent form (ICF)

Exclusion Criteria:

  1. Subject is a pre-term (<37th gestational week)
  2. Subject or mother is suffering from an acute or chronic disease followed by medication therapy at the time of pre-examination
  3. Subject is suffering from (congenital) gastrointestinal disease or malformation (followed by medication)
  4. Subject is suffering/ suffered from infection (which lead to diarrhoea or vomit-ing) in previous 14 days
  5. Subject has been administered antibiotics and/or laxatives in the previous 14 days prior to the start of the intervention
  6. Subject has a (hereditary) fructose/lactose intolerance and/or (food) allergy
  7. Subject is suffering from carbohydrate malabsorption
  8. Drug or alcohol abuse by mother of subject
  9. Subject is a hydrogen non producer.
  10. Subject is currently involved or will be involved in another clinical or food study
  11. Subject is not suitable for participation in the study according to the PI/study personnel
  12. It is impossible for the subject to travel to the study center on Study Days 1 and 2

Sites / Locations

  • The Tel Aviv Sourasky Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Isomaltulose

Sucrose

Arm Description

Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)

Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)

Outcomes

Primary Outcome Measures

hydrogen breath

Secondary Outcome Measures

Full Information

First Posted
September 19, 2014
Last Updated
December 24, 2014
Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Beneo GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT02247102
Brief Title
Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
February 2015 (Anticipated)
Study Completion Date
August 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tel-Aviv Sourasky Medical Center
Collaborators
Beneo GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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, 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. 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malabsorption

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Isomaltulose
Arm Type
Experimental
Arm Description
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Arm Title
Sucrose
Arm Type
Active Comparator
Arm Description
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Intervention Type
Dietary Supplement
Intervention Name(s)
Isomaltulose
Other Intervention Name(s)
Palatinose™
Intervention 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).
Intervention Type
Dietary Supplement
Intervention Name(s)
Sucrose
Intervention 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).
Primary Outcome Measure Information:
Title
hydrogen breath
Time Frame
3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Subject was healthy-born at term (37th-42th gestational week) and is healthy at the time of pre-examination Subject is aged 6-12 months at the time of pre-examination Subject ranges between 5th and 95th percentile for age (EURO Growth Guide-lines) Subject has been formula-fed (and complementary food, such as fruit or car-rots, have already been introduced) and not exclusively breast-fed for at least 4 weeks prior onset of the trial Parents/caretakers understand the English or Hebrew language and are able and willing to follow the study instructions and fill out questionnaires Subject is suitable for participation in the study according to the PI/study per-sonnel Parents/caretakers have voluntarily agreed to participate and successfully completed the informed consent form (ICF) Exclusion Criteria: Subject is a pre-term (<37th gestational week) Subject or mother is suffering from an acute or chronic disease followed by medication therapy at the time of pre-examination Subject is suffering from (congenital) gastrointestinal disease or malformation (followed by medication) Subject is suffering/ suffered from infection (which lead to diarrhoea or vomit-ing) in previous 14 days Subject has been administered antibiotics and/or laxatives in the previous 14 days prior to the start of the intervention Subject has a (hereditary) fructose/lactose intolerance and/or (food) allergy Subject is suffering from carbohydrate malabsorption Drug or alcohol abuse by mother of subject Subject is a hydrogen non producer. Subject is currently involved or will be involved in another clinical or food study Subject is not suitable for participation in the study according to the PI/study personnel It is impossible for the subject to travel to the study center on Study Days 1 and 2
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nachum Vaisman, MD
Phone
+972.524.266.596
Email
nachumv@tlvmc.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Carolin Sieland
Phone
+49 6359 803 831
Email
Carolin.Sieland@beneo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nachum Vaisman, MD
Organizational Affiliation
The Tel Aviv Sourasky Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Tel Aviv Sourasky Medical Center
City
Tel Aviv
Country
Israel
Individual Site Status
Recruiting

12. IPD Sharing Statement

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Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants

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