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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT02247102
• Date of registration: 19/09/2014
• Prospective Registration: No
• Primary sponsor: Tel-Aviv Sourasky Medical Center
• Public title: Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 40
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT02247102
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic
• Phase: Phase 3

Countries of recruitment

Israel

Contacts

• Name: Nachum Vaisman, MD
• Affiliation: The Tel Aviv Sourasky Medical Center

• Name: Nachum Vaisman, MD

Key inclusion & exclusion criteria

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



Age minimum: 6 Months
Age maximum: 12 Months
Gender: Both

Health Condition(s) or Problem(s) studied

Malabsorption

Intervention(s)

Dietary Supplement: Isomaltulose

Dietary Supplement: Sucrose

Primary Outcome(s)

hydrogen breath [Time Frame: 3 hours]

Secondary ID(s)

TASMC-14-NV-132-CTIL

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Beneo GmbH