Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants
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
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Sep 2014
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
September 19, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedDecember 25, 2014
December 1, 2014
5 months
September 19, 2014
December 24, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
hydrogen breath
3 hours
Study Arms (2)
Isomaltulose
EXPERIMENTALDosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Sucrose
ACTIVE COMPARATORDosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
Interventions
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).
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).
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tel-Aviv Sourasky Medical Centerlead
- Beneo GmbHcollaborator
Study Sites (1)
The Tel Aviv Sourasky Medical Center
Tel Aviv, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nachum Vaisman, MD
The Tel Aviv Sourasky Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2014
First Posted
September 23, 2014
Study Start
September 1, 2014
Primary Completion
February 1, 2015
Study Completion
August 1, 2015
Last Updated
December 25, 2014
Record last verified: 2014-12