Status:
UNKNOWN
Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants
Lead Sponsor:
Tel-Aviv Sourasky Medical Center
Collaborating Sponsors:
Beneo GmbH
Conditions:
Malabsorption
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
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 t...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2015
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT02247102
Start Date
September 1 2014
End Date
August 1 2015
Last Update
December 25 2014
Active Locations (1)
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1
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel