Clinical trial NCT01603719: Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics
Official title: Safety and Efficacy of an Infant Starter Formula With Prebiotics (GOS) and a Higher Content of Beta-palmitate on Stool Characteristics, Food Tolerance, Calcium Uptake, and Incidence of Infectious Disease in the First Year of Life
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections
Stool Flora
Stool Biochemistry
Constipation
Food Intolerance
Keywords: infant formula
prebiotics
beta-palmitate
stool flora
bifidogenic
Lead sponsor: Waldkrankenhaus Protestant Hospital, Spandau
Sponsor class: OTHER
First posted: 2012-05-23
Enrollment: 128
Sex: ALL
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: number of gastrointestinal infections
timeFrame: within first year of life
Secondary outcomes:
measure: proportion of bifidobacteria on total stool bacteria
timeFrame: after 6 and 12 weeks intervention
measure: number of infectious episodes (gastrointestinal, respiratory, fever episodes)
timeFrame: within first year of life
measure: anthropometric parameters (gain in weight, length, head circumference)
timeFrame: after 6 weeks, after 12 weeks intervention
measure: symptoms of food intolerance, constipation, colics
timeFrame: after 6 weeks, 12 weeks intervention
measure: stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
timeFrame: after 6 weeks, 12 weeks intervention
measure: atopic manifestation
timeFrame: within 1st year of life
measure: erythrocytes´ fatty acid profile
timeFrame: after 6 weeks intervention
measure: calcium absorption
timeFrame: after 6 weeks, 12 weeks intervention
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Evangelisches Waldkrankenhaus Spandau
Study officials:
affiliation: Waldkrankenhaus Protestant Hospital, Spandau
name: Frank Jochum, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambidou M, Alteheld B, Fimmers R, Jochum F, Nomayo A, Stehle P. Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns. Ann Nutr Metab. 2021;77(3):138-145. doi: 10.1159/000515705. Epub 2021 Apr 30.
citation: Nomayo A, Schwiertz A, Rossi R, Timme K, Foster J, Zelenka R, Tvrdik J, Jochum F. Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial. Mol Cell Pediatr. 2020 Jul 2;7(1):6. doi: 10.1186/s40348-020-00098-1.