MalabsorptionPhase 3NCT02247102
Investigate the Breath Hydrogen Exhalation After a Test Meal Containing Isomaltulose or Sucrose in Infants
A Phase 3 study testing Isomaltulose and Sucrose in people with Malabsorption, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
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… Read more about this study
- Who is it for?
- Ages 6 to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Malabsorption
- What is being tested?
- Isomaltulose and Sucrose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2014to Aug 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The Tel Aviv Sourasky Medical Center
Tel Aviv
About this study
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
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.
Read more
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.
Read the detailed 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.
- Conditions
- Malabsorption
- Being tested
- Isomaltulose, Sucrose
- Medical subject headings
- Malabsorption Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsomaltuloseDietary supplement
Also called Palatinose™
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).
SucroseDietary supplement
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).
| Study group | Role | What they receive |
|---|---|---|
| Isomaltulose | Experimental | Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose |
| Sucrose | Active comparator | Dosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) Receives: Dietary Supplement: Isomaltulose; Dietary Supplement: Sucrose |
What is being measured
The primary outcome is the main question the study is designed to answer.
hydrogen breath
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionFeb 2015 (estimated)
- Study completionAug 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalabsorptionStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Collaborators
- Beneo GmbH
- Responsible party
- Sponsor
- Investigators
- Nachum Vaisman, MD, Principal investigator, The Tel Aviv Sourasky Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02247102
- Sponsor's protocol ID
- TASMC-14-NV-132-CTIL
- Status last verified
- Dec 2014
- First submitted
- 19 Sep 2014
- Last updated
- 25 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02247102
- Acronym / sponsor ID
- TASMC-14-NV-132-CTIL
- Conditions
- Malabsorption
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Collaborators
- Beneo GmbH
- Study start
- Sep 2014
- Primary completion
- Feb 2015 (estimated)
- Study completion
- Aug 2015 (estimated)
- First posted
- 23 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isomaltulose | Experimental | Dietary Supplement: Isomaltulose, Dietary Supplement: SucroseDosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) |
| Sucrose | Active comparator | Dietary Supplement: Isomaltulose, Dietary Supplement: SucroseDosage of 1 g/ kg body weight (rounded up to the nearest 0.5 kg) |
Who may qualify
- Ages
- 6 to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IsomaltuloseAlso: Palatinose™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 | Isomaltulose, Sucrose |
| SucroseEach 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). | Dietary supplement | Isomaltulose, Sucrose |
Primary outcome
hydrogen breath
Time frame: 3 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nachum Vaisman, MD principal investigator
The Tel Aviv Sourasky Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Isomaltulose and Sucrose in people with Malabsorption, run by Tel-Aviv Sourasky Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nachum Vaisman, MD (+972.524.266.596, nachumv@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
hydrogen breath (time frame: 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Dec 2014.