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

Malabsorption Clinical Trial

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

Status Recruiting

Clinical Trial 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,

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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Malabsorption
• Malabsorption Syndromes

• NCT number: NCT02247102
• Study type: Interventional
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Nachum Vaisman, MD
• Phone: +972.524.266.596
• Email: nachumv@tlvmc.gov.il
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2014
• Completion date: August 2015