Constipation, Food Intolerance, Infections, Stool Biochemistry, Stool Flora
Conditions
Keywords
infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic
Brief summary
The purpose of this clinical trial is to evaluate the effect of a new infant starter formula with added prebiotics (GOS) and with a fat blend rich in beta-palmitate.
Detailed description
An experimental infant formula with added prebiotics (GOS) and with a higher content of palmitic acid esterified in beta-position is to be tested in a double-blinded randomized controlled trial. The addition of prebiotics to an infant formula should favor growth of a beneficial bifidogenic intestinal flora and have positive effects on immunity, promote softer stool formation and short chain fatty acid content in the stools. Higher proportion of beta-palmitic acid esterified in 2nd position of the triglyceride should reduce formation of fatty acid-calcium soaps in the stools and promote calcium and fat absorption in the gut, therfor reduce symptoms of constipation and colics.
Interventions
DIETARY_SUPPLEMENTnew infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life
Sponsors
Waldkrankenhaus Protestant Hospital, Spandau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 10 Days
Healthy volunteers
Yes
Inclusion criteria
* healthy term neonates * gestational age 37 to 42 weeks * birth weight 10th to 90th percentile (Voigt reference) * infants being exclusively formula-fed at enrollment
Exclusion criteria
* infants with high risk of atopic disease due to family history * congenital disorder or syndrome with need for special diet / impairment of growth * antibiotic medication prior to enrollment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| number of gastrointestinal infections | within first year of life |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of infectious episodes (gastrointestinal, respiratory, fever episodes) | within first year of life | — |
| anthropometric parameters (gain in weight, length, head circumference) | after 6 weeks, after 12 weeks intervention | — |
| symptoms of food intolerance, constipation, colics | after 6 weeks, 12 weeks intervention | number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation |
| proportion of bifidobacteria on total stool bacteria | after 6 and 12 weeks intervention | — |
| atopic manifestation | within 1st year of life | incidence atopic dermatitis |
| erythrocytes´ fatty acid profile | after 6 weeks intervention | palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane) |
| calcium absorption | after 6 weeks, 12 weeks intervention | urinary calcium-creatinin ratio, serum alkaline phosphatase |
| stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools) | after 6 weeks, 12 weeks intervention | — |
Countries
Germany
Outcome results
None listed