SteatorrheaPhase 2NCT01184378
Tolerance and Digestibility of a New Formula in Healthy Infants
A Phase 2 study testing dairy lipids and soluble milk proteins in people with Steatorrhea and Growth, run by Lactalis at 2 sites in France.
Trial summary
The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk. Read more about this study
- Who is it for?
- Ages 2 to 4 monthsHealthy volunteers can take part
- Conditions the study is for
- Steatorrhea, Growth
- What is being tested?
- dairy lipids and soluble milk proteins
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- Nov 2008to Jan 2011
- Phase
- Phase 2
- 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 2 to 4 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- normal growth;
- considered as healthy by the investigator according to the medical interrogation and the clinical examination;
- receiving exclusively infant formula for at least 15 days.
- without any solid food during the month of the study
Who cannot join
- Premature born children or small born weights;
- Children breast-fed or weaned for less than 15 days;
- Children with solid food
- Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
- Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
- Digestive pathology previous to the inclusion, in particular infectious (rotavirus, gastroenteritis) or functional symptoms (important stomach pains, colicky) having required a lot of change in formula quality;
- Children under medical treatment (ex: paracetamol).
Trial locations and contacts
2 sites in 1 country.
France2 sites
Faculté de Médecine
Dijon, 21078
Hopital Mère-Enfants
Rennes, 35000
About this study
Official title: Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
The great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.
- Conditions
- Steatorrhea, Growth
- Being tested
- dairy lipids and soluble milk proteins
- Keywords
- infant formula, dairy fat, soluble milk protein
- Medical subject headings
- Steatorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dairy lipids and soluble milk proteinsDietary supplement
one month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake
| Study group | Role | What they receive |
|---|---|---|
| control formula | Placebo comparator | formula containing only vegetable fats Receives: Dietary Supplement: dairy lipids and soluble milk proteins |
| new formula | Experimental | new formula with dairy lipids and soluble milk proteins Receives: Dietary Supplement: dairy lipids and soluble milk proteins |
What is being measured
The primary outcome is the main question the study is designed to answer.
digestibility of lipids in formula
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
Measured: during the 30d consumption period
Secondary outcomes (1)
tolerance and growth
Measured: during the 30d of formula intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2010 (estimated)
- Study startNov 2008
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SteatorrheaStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lactalis
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184378
- Sponsor's protocol ID
- LRD-08-15
- Status last verified
- Jan 2011
- First submitted
- 17 Aug 2010
- Last updated
- 26 Jan 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Tolerance and Lipid Digestibility of a Formula in Healthy 3 Months Infants
- ClinicalTrials.gov ID
- NCT01184378
- Acronym / sponsor ID
- LRD-08-15
- Conditions
- Steatorrhea, Growth
- Keywords
- infant formula, dairy fat, soluble milk protein
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- LactalisIndustry (pharma, biotech, devices)
- Study start
- Nov 2008
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 18 Aug 2010 (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 great majority of infants formula contain fats exclusively from vegetable oil. Nevertheless, the use of both vegetable and dairy lipids is on a real interest to obtain an infant formula closer to the nutritional composition of maternal milk.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control formula | Placebo comparator | Dietary Supplement: dairy lipids and soluble milk proteinsformula containing only vegetable fats |
| new formula | Experimental | Dietary Supplement: dairy lipids and soluble milk proteinsnew formula with dairy lipids and soluble milk proteins |
Who may qualify
- Ages
- 2 to 4 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- normal growth;
- considered as healthy by the investigator according to the medical interrogation and the clinical examination;
- receiving exclusively infant formula for at least 15 days.
- without any solid food during the month of the study
Key exclusion criteria (7 listed)
- Premature born children or small born weights;
- Children breast-fed or weaned for less than 15 days;
- Children with solid food
- Food allergy, particularly in milk proteins allergy , and lactose intolerance ;
- Tumoral, inflammatory, cardiac, lung, renal, digestive diseases(syndrome of malabsorption);
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 |
|---|---|---|
| dairy lipids and soluble milk proteinsone month formula supplementation feces are collected during a 3 days period after 15 and 30 days of formula intake | Dietary supplement | control formula, new formula |
Primary outcome
digestibility of lipids in formula
Time frame: during the 30d consumption period
lipid content determination in feces during a 3 days period of collection after 15d and 30d of formula intake
1 secondary outcome
tolerance and growth
Time frame: during the 30d of formula intake
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2011.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing dairy lipids and soluble milk proteins in people with Steatorrhea and Growth, run by Lactalis at 2 sites in France.
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 4 inclusion and 7 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: finished, as of the sponsor's last update on 26 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
digestibility of lipids in formula (time frame: during the 30d consumption period). 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 26 Jan 2011.