- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02247102
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Nachum Vaisman, MD
- Phone Number: +972.524.266.596
- Email: nachumv@tlvmc.gov.il
Study Contact Backup
- Name: Carolin Sieland
- Phone Number: +49 6359 803 831
- Email: Carolin.Sieland@beneo.com
Study Locations
-
-
-
Tel Aviv, Israel
- Recruiting
- The Tel Aviv Sourasky Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Isomaltulose
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
|
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).
Other Names:
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). |
Active Comparator: Sucrose
Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg)
|
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).
Other Names:
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). |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
hydrogen breath
Time Frame: 3 hours
|
3 hours
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Nachum Vaisman, MD, The Tel Aviv Sourasky Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TASMC-14-NV-132-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Malabsorption
-
University Hospital, Gentofte, CopenhagenCompleted
-
Maastricht University Medical CenterFrieslandCampinaRecruitingProtein MalabsorptionNetherlands
-
Filip Krag KnopHerlev and Gentofte HospitalCompleted
-
AlbireoCompleted
-
Lindenwood UniversityIncrenovo, LLCCompletedProtein MalabsorptionUnited States
-
Unity Health TorontoUniversity of Toronto; Glycemic Index Laboratories, Inc; Iowa State University; Ingredion IncorporatedCompletedIleostomy - Stoma | Malabsorption; CarbohydrateCanada
-
Imperial College Healthcare NHS TrustCompletedPrimary Bile Acid Malabsorption | Secondary Bile Acid Malabsorption | Chronic DiarrhoeaUnited Kingdom
-
Mayo ClinicNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); National...CompletedFecal Incontinence | Bile Acid MalabsorptionUnited States
-
Musclegen Research, Inc.WakeMed Bariatric Surgery & Weight Loss CenterUnknownProtein Intolerance | Protein Malabsorption | Absorption; Disorder, ProteinUnited States
-
Lars Kristian MunckCompletedBile Acid MalabsorptionDenmark
Clinical Trials on Isomaltulose
-
University of GiessenNumico ResearchCompleted
-
Clinical Nutrition Research Centre, SingaporeCompletedObesity | Type 2 Diabetes | Pre DiabetesSingapore
-
Beneo-InstituteCompleted
-
Clinical Nutrition Research Centre, SingaporeCompletedDiabetes Mellitus
-
Swansea UniversityBeneo GmbHNot yet recruitingA Randomised Counter-balanced Intervention Study in Endurance Athletes
-
Swansea UniversityCompletedDementiaUnited Kingdom
-
Swansea UniversityCompletedHungerUnited Kingdom
-
Beneo-InstituteCompletedBody Weight | Diet Modification | Overweight and ObesityUnited Kingdom
-
Beneo-InstituteBioTeSys GmbHCompleted
-
German Institute of Human NutritionUnknownHypertension | Obesity | Metabolic Syndrome | NAFLDGermany