Dietary ModificationNCT02796872
The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
A study testing GOS, B-GOS 3% and B-GOS 2% in people with Dietary Modification, run by Clasado.
Trial summary
This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function. Read more about this study
- Who is it for?
- Ages 12 to 18 daysHealthy volunteers can take part
- Conditions the study is for
- Dietary Modification
- What is being tested?
- GOS, B-GOS 3% and B-GOS 2%
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 392 participants
- Where
- No sites listed yet
- Study dates
- Jun 2016to May 2017
- 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 12 to 18 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)
- Singleton birth
- Gestational age of 37-42 weeks (36 weeks and six days is considered 36 weeks gestational age)
- Birth weight of 2500g to 4000g
- Signed informed consent obtained for infant's participation in the survey
- Parent or guardian of infant agrees not to enroll infant in another interventional clinical research survey while participating in this survey
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- APGAR score after 5 minutes of life > 7
- Consuming only one source of nutrition
- Formula-fed infant: Infant consuming infant formula as the sole source of nutrition for 7 consecutive days prior to randomization
- Breastfed infant: Infant consuming mother's breast milk as the sole source of nutrition for 7 consecutive days prior to registration
Who cannot join
- Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
- Diseases jeopardizing intrauterine growth
- Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
- Infant born from mother suffering from metabolic and/or chronic diseases
- Infant with an acute infection or gastroenteritis at time of randomization or registration
- Infant consuming supplemental foods
- Evidence of feeding difficulties or formula intolerance, such as vomiting or poor intake at time of randomization or registration
- Infant is immunocompromised (according to a doctor's diagnosis of immunodeficiency such as Combined Immunodeficiencies, DiGeorge Syndrome, Wiskott-Aldrich Syndrome, Severe Congenital Neutropenia and Secondary Immunodeficiencies linked to HIV infection, Down Syndrome or others) and children with known head/brain disease/injury such as Microcephaly, Macrocephaly or others
About this study
This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.
- Conditions
- Dietary Modification
- Being tested
- GOS, B-GOS 3%, B-GOS 2%, Mother's breast milk
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GOSDietary supplement
GOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3)
B-GOS 3%Dietary supplement
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2)
B-GOS 2%Dietary supplement
Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3)
Mother's breast milkDietary supplement
exclusively breastfed infants for at least 7 days prior to enrollment
| Study group | Role | What they receive |
|---|---|---|
| mother's breast milk. | Placebo comparator | mother's breast milk. Receives: Dietary Supplement: Mother's breast milk |
| other GOS | Active comparator | Commercial infant formula containing 4% w/w FOS:GOS (1:3) Receives: Dietary Supplement: GOS |
| B-GOS 3% | Experimental | Commercial infant formula containing 3% w/w FOS:B -GOS (1:2) Receives: Dietary Supplement: B-GOS 3% |
| B-GOS 2% | Experimental | Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) Receives: Dietary Supplement: B-GOS 2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric parameters
body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age
Measured: 6 months
Fecal bacteria analysis
- Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age
Measured: 6 months
Secondary outcomes (5)
Dietary
tool characteristics, tolerance, formula acceptance, stress and 3-day well-being (quality of life) questionnaire prior to each survey visit recorded at 30, 60, 90, 120, 150 and 180 days of age
Measured: 6 months
Formula intake
Formula intake (24-hour dietary recall) at 30, 60, 90, 120, 150 and 180 days of age
Measured: 6 months
All medically confirmed adverse events and antibiotic record
All medically confirmed adverse events including crying, gaseous colics, regurgitation, vomit, skin rashes, fever and concomitant medications recorded on medical records as a measure of safety and tolerability throughout the survey period.
Measured: 6 months
Fecal sIgA and SCFA analysis
Fecal sIgA and SCFA analysis at 30 days of age (visit 1) and 180 days of age (visit 6)
Measured: 6 months
Saliva cortisol, IgA, chromogranin A and lysozyme
Saliva cortisol, IgA, chromogranin A and lysozyme at 30, 90 and 180 days of age
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 posted13 Jun 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2016
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dietary ModificationStudies 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 N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clasado
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796872
- Sponsor's protocol ID
- CLA12016CN
- Status last verified
- Feb 2017
- First submitted
- 30 May 2016
- Last updated
- 19 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Feeding Infant Formula With Bimuno Galactooligosaccharide (GOS)
- ClinicalTrials.gov ID
- NCT02796872
- Acronym / sponsor ID
- CLA12016CN
- Conditions
- Dietary Modification
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 392 participants (actual)
- Lead sponsor
- ClasadoIndustry (pharma, biotech, devices)
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 13 Jun 2016 (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.
This survey is a multicenter, double-blind, randomized, controlled, parallel-designed, prospective trial and is intended to evaluate the Bimuno GOS effects on growth, tolerance, gut health, fecal flora and immune function.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mother's breast milk. | Placebo comparator | Dietary Supplement: Mother's breast milkmother's breast milk. |
| other GOS | Active comparator | Dietary Supplement: GOSCommercial infant formula containing 4% w/w FOS:GOS (1:3) |
| B-GOS 3% | Experimental | Dietary Supplement: B-GOS 3%Commercial infant formula containing 3% w/w FOS:B -GOS (1:2) |
| B-GOS 2% | Experimental | Dietary Supplement: B-GOS 2%Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) |
Who may qualify
- Ages
- 12 to 18 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- o 15 ± 3 days of age at randomization, inclusive (day of birth is considered day 0)
Key exclusion criteria (8 listed)
- Infant with inborn malformation and with hereditary and/or chronic and/or inborn diseases requiring hospital care superior to 7 days
- Diseases jeopardizing intrauterine growth
- Weight at Visit 1 is <95% of birth weight [(weight at Visit 1÷birth weight) x 100 <95%]
- Infant born from mother suffering from metabolic and/or chronic diseases
- Infant with an acute infection or gastroenteritis at time of randomization or registration
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 |
|---|---|---|
| GOSGOS resource (β-galactosidase from Bacillus circulans) Commercial infant formula containing 4% w/w FOS:GOS (1:3) | Dietary supplement | other GOS |
| B-GOS 3%Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 3% w/w FOS:B -GOS (1:2) | Dietary supplement | B-GOS 3% |
| B-GOS 2%Bimuno-GOS (B-GOS) resource (β-galactosidase from Bifidobacteriumbifidum) Commercial infant formula containing 4% w/w FOS:B -GOS (1:3) | Dietary supplement | B-GOS 2% |
| Mother's breast milkexclusively breastfed infants for at least 7 days prior to enrollment | Dietary supplement | mother's breast milk. |
Primary outcome
Anthropometric parameters
Time frame: 6 months
body length, body weight, and head circumferences at enrollment (15± 3 days of age), 30, 60, 90, 120, 150 and 180 days of age
Fecal bacteria analysis
Time frame: 6 months
o Fecal bacteria analysis of Bifidobacterium, Lactobacillus, Clostridium perfringens and Escherichia coli at the enrollment 30 days of age ,120 days of age and 180 days of age
5 secondary outcomes
Dietary
Time frame: 6 months
Formula intake
Time frame: 6 months
All medically confirmed adverse events and antibiotic record
Time frame: 6 months
Fecal sIgA and SCFA analysis
Time frame: 6 months
Saliva cortisol, IgA, chromogranin A and lysozyme
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 19 Jul 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing GOS, B-GOS 3% and B-GOS 2% in people with Dietary Modification, run by Clasado.
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 10 inclusion and 8 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 19 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Anthropometric parameters (time frame: 6 months). The study lists 2 primary outcomes in all. 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 19 Jul 2017.