Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics
NCT ID: NCT01603719
Last Updated: 2020-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
128 participants
INTERVENTIONAL
2011-08-31
2020-01-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Standard Formula
Standard formula with no supplementation
No interventions assigned to this group
experimental formula
infant formula with higher beta-palmitate and supplemented GOS
new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life
Interventions
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new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life
Eligibility Criteria
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Inclusion Criteria
* gestational age 37 to 42 weeks
* birth weight 10th to 90th percentile (Voigt reference)
* infants being exclusively formula-fed at enrollment
Exclusion Criteria
* congenital disorder or syndrome with need for special diet / impairment of growth
* antibiotic medication prior to enrollment
10 Days
ALL
Yes
Sponsors
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Waldkrankenhaus Protestant Hospital, Spandau
OTHER
Responsible Party
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Antonia Nomayo, MD
MD
Principal Investigators
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Frank Jochum, MD
Role: PRINCIPAL_INVESTIGATOR
Waldkrankenhaus Protestant Hospital, Spandau
Locations
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Evangelisches Waldkrankenhaus Spandau
Berlin, , Germany
Countries
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References
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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.
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.
Other Identifiers
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EWK-001
Identifier Type: -
Identifier Source: org_study_id
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