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

NCT02247102 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2014-12-25

No results posted yet for this study

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.

Conditions

  • Malabsorption

Interventions

DIETARY_SUPPLEMENT

Isomaltulose

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).

DIETARY_SUPPLEMENT

Sucrose

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).

Sponsors & Collaborators

  • Beneo GmbH

    collaborator INDUSTRY

  • Tel-Aviv Sourasky Medical Center

    lead OTHER_GOV

Principal Investigators

  • Nachum Vaisman, MD · The Tel Aviv Sourasky Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-09-30
Primary Completion
2015-02-28
Completion
2015-08-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02247102 on ClinicalTrials.gov