Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Waldkrankenhaus Protestant Hospital, Spandau128 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

128

Conditions

Infections Stool Flora Stool Biochemistry Constipation Food Intolerance

Interventions

new infant formula with prebiotics and beta-palmitateDIETARY_SUPPLEMENT

experimental infant formula as sole source of nutrition over first 12 weeks of life

Eligibility

Sex: ALLMax age: 10 DaysHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Evangelisches Waldkrankenhaus Spandau

Berlin, Germany

Outcomes

Primary Outcomes

number of gastrointestinal infections

Time frame: within first year of life

Secondary Outcomes

proportion of bifidobacteria on total stool bacteria

Time frame: after 6 and 12 weeks intervention

number of infectious episodes (gastrointestinal, respiratory, fever episodes)

Time frame: within first year of life

anthropometric parameters (gain in weight, length, head circumference)

Time frame: after 6 weeks, after 12 weeks intervention

symptoms of food intolerance, constipation, colics

number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation

Time frame: after 6 weeks, 12 weeks intervention

stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)

Time frame: after 6 weeks, 12 weeks intervention

atopic manifestation

incidence atopic dermatitis

Time frame: within 1st year of life

erythrocytes´ fatty acid profile

palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)

Time frame: after 6 weeks intervention

calcium absorption

urinary calcium-creatinin ratio, serum alkaline phosphatase

Time frame: after 6 weeks, 12 weeks intervention

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.