Infant NutritionNCT01036243
Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics
A study testing test formula 1, test formula 2 and test formula 3 in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Thailand.
Trial summary
To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula. Read more about this study
- Who is it for?
- Ages 11 to 30 daysHealthy volunteers can take part
- Conditions the study is for
- Infant Nutrition
- What is being tested?
- test formula 1, test formula 2 and test formula 3
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteThailand
- Study dates
- Dec 2009to Apr 2012
- Phase
- Interventional
- 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 11 to 30 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants, 0-1 month old at point of enrollment
- Birth weight < 2500g and > 4500g
- Gestational age < 37 weeks and > 42 weeks
- Infants who cannot be breastfed because of the maternal status
- Willing to exclusively consume the assigned study formula with whey protein
- Are likely to be compliant
- Mother/caregiver demonstrates an understanding of the given information and ability to record the requested data
Who cannot join
- Congenital illness or malformation
- Significant pre-natal and/or post-natal disease
- Receiving systemic antibiotic treatment at time of enrolment
- Infant with symptoms of allergy to cow's milk
- Infant's family cannot be expected to comply with treatment (feeding regimen)
- Subjects who cannot be expected to comply with treatment
- Currently participating or having participated in another clinical trial during the last month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics
To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.
Read the detailed description
Infants often experience undesirable gastrointestinal effects, such as constipation, flatulence. These symptoms are often perceived by the parents as being related to the diet (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of the most commonly encountered problems within the first three months of life. The etiology of the disorder remains unknown however, three main theories have been proposed to explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's milk protein or other food constituents. e.g. the protein source, the iron content, hydrolyzation of the protein, or the fat source.
It has been reported that infants receiving a casein predominant formula had less unformed stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein formula have shown more liquid stools.
A reduction of crying hours was also described in infant receiving an hydrolyzed formula. Some probiotics were reported with potential benefit on the gut comfort.
- Conditions
- Infant Nutrition
- Being tested
- test formula 1, test formula 2, test formula 3, reference formula
- Keywords
- digestive tolerance, night sleep, crying, growth
- Medical subject headings
- Crying
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
test formula 1Dietary supplement
Also called for 0-6 months as per standard requirement
hydrolyzed formula with probiotics
test formula 2Dietary supplement
Also called suitable for 0-6 months as per standard requirement
acidified hydrolyzed formula
test formula 3Dietary supplement
Also called suitable for 0-6 months of age as per standard requirement
hydrolyzed formula without probiotics
reference formulaDietary supplement
Also called suitable for 0-6 months of age as per standard requirement
standard infant formula
| Study group | Role | What they receive |
|---|---|---|
| Test formula 1 | Experimental | Hydrolyzed formula with probiotics Receives: Dietary Supplement: test formula 1 |
| test formula 2 | Active comparator | acidified hydrolyzed formula. Receives: Dietary Supplement: test formula 2 |
| Test formula 3 | Active comparator | hydrolyzed formula without probiotics Receives: Dietary Supplement: test formula 3 |
| reference product | Active comparator | standard infant formula Receives: Dietary Supplement: reference formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of crying/fussing from 1 to 3 months.
Measured: 3 months
Secondary outcomes (1)
growth and night sleep
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJan 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant NutritionStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University
- Responsible party
- Sponsor
- Investigators
- A/Prof. Boosba Vivatvakin, MD, Principal investigator, Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01036243
- Sponsor's protocol ID
- 07.06 INF
- Status last verified
- Jun 2012
- First submitted
- 17 Dec 2009
- Last updated
- 22 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of a Slightly Hydrolyzed Starter Formula Containing Probiotics
- ClinicalTrials.gov ID
- NCT01036243
- Acronym / sponsor ID
- 07.06 INF
- Conditions
- Infant Nutrition
- Keywords
- digestive tolerance, night sleep, crying, growth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 480 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- Chulalongkorn University
- Study start
- Dec 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 21 Dec 2009 (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.
To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.
Detailed description
Infants often experience undesirable gastrointestinal effects, such as constipation, flatulence. These symptoms are often perceived by the parents as being related to the diet (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of the most commonly encountered problems within the first three months of life. The etiology of the disorder remains unknown however, three main theories have been proposed to explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's milk protein or other food constituents. e.g. the protein source, the iron content, hydrolyzation of the protein, or the fat source.
It has been reported that infants receiving a casein predominant formula had less unformed stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein formula have shown more liquid stools.
A reduction of crying hours was also described in infant receiving an hydrolyzed formula. Some probiotics were reported with potential benefit on the gut comfort.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test formula 1 | Experimental | Dietary Supplement: test formula 1Hydrolyzed formula with probiotics |
| test formula 2 | Active comparator | Dietary Supplement: test formula 2acidified hydrolyzed formula. |
| Test formula 3 | Active comparator | Dietary Supplement: test formula 3hydrolyzed formula without probiotics |
| reference product | Active comparator | Dietary Supplement: reference formulastandard infant formula |
Who may qualify
- Ages
- 11 to 30 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Healthy infants, 0-1 month old at point of enrollment
- Birth weight < 2500g and > 4500g
- Gestational age < 37 weeks and > 42 weeks
- Infants who cannot be breastfed because of the maternal status
- Willing to exclusively consume the assigned study formula with whey protein
Key exclusion criteria (7 listed)
- Congenital illness or malformation
- Significant pre-natal and/or post-natal disease
- Receiving systemic antibiotic treatment at time of enrolment
- Infant with symptoms of allergy to cow's milk
- Infant's family cannot be expected to comply with treatment (feeding regimen)
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 |
|---|---|---|
| test formula 1Also: for 0-6 months as per standard requirementhydrolyzed formula with probiotics | Dietary supplement | Test formula 1 |
| test formula 2Also: suitable for 0-6 months as per standard requirementacidified hydrolyzed formula | Dietary supplement | test formula 2 |
| test formula 3Also: suitable for 0-6 months of age as per standard requirementhydrolyzed formula without probiotics | Dietary supplement | Test formula 3 |
| reference formulaAlso: suitable for 0-6 months of age as per standard requirementstandard infant formula | Dietary supplement | reference product |
Primary outcome
incidence of crying/fussing from 1 to 3 months.
Time frame: 3 months
1 secondary outcome
growth and night sleep
Time frame: 6 months
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 22 Jun 2012.
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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.
A/Prof. Boosba Vivatvakin, MD principal investigator
Pediatric Gastroenterology Unit,Faculty of Medicine, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing test formula 1, test formula 2 and test formula 3 in people with Infant Nutrition, run by Société des Produits Nestlé (SPN) at 1 site in Thailand.
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 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 22 Jun 2012. 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 Thailand. 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.
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?
incidence of crying/fussing from 1 to 3 months. (time frame: 3 months). 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 22 Jun 2012.