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Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Primary Purpose

Infections, Stool Flora, Stool Biochemistry

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
new infant formula with prebiotics and beta-palmitate
Sponsored by
Waldkrankenhaus Protestant Hospital, Spandau
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections focused on measuring infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic

Eligibility Criteria

undefined - 10 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Evangelisches Waldkrankenhaus Spandau

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard Formula

experimental formula

Arm Description

Standard formula with no supplementation

infant formula with higher beta-palmitate and supplemented GOS

Outcomes

Primary Outcome Measures

number of gastrointestinal infections

Secondary Outcome Measures

proportion of bifidobacteria on total stool bacteria
number of infectious episodes (gastrointestinal, respiratory, fever episodes)
anthropometric parameters (gain in weight, length, head circumference)
symptoms of food intolerance, constipation, colics
number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
atopic manifestation
incidence atopic dermatitis
erythrocytes´ fatty acid profile
palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)
calcium absorption
urinary calcium-creatinin ratio, serum alkaline phosphatase

Full Information

First Posted
May 15, 2012
Last Updated
June 5, 2020
Sponsor
Waldkrankenhaus Protestant Hospital, Spandau
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1. Study Identification

Unique Protocol Identification Number
NCT01603719
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
January 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Waldkrankenhaus Protestant Hospital, Spandau

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Stool Flora, Stool Biochemistry, Constipation, Food Intolerance
Keywords
infant formula, prebiotics, beta-palmitate, stool flora, bifidogenic

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Formula
Arm Type
No Intervention
Arm Description
Standard formula with no supplementation
Arm Title
experimental formula
Arm Type
Experimental
Arm Description
infant formula with higher beta-palmitate and supplemented GOS
Intervention Type
Dietary Supplement
Intervention Name(s)
new infant formula with prebiotics and beta-palmitate
Intervention Description
experimental infant formula as sole source of nutrition over first 12 weeks of life
Primary Outcome Measure Information:
Title
number of gastrointestinal infections
Time Frame
within first year of life
Secondary Outcome Measure Information:
Title
proportion of bifidobacteria on total stool bacteria
Time Frame
after 6 and 12 weeks intervention
Title
number of infectious episodes (gastrointestinal, respiratory, fever episodes)
Time Frame
within first year of life
Title
anthropometric parameters (gain in weight, length, head circumference)
Time Frame
after 6 weeks, after 12 weeks intervention
Title
symptoms of food intolerance, constipation, colics
Description
number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation
Time Frame
after 6 weeks, 12 weeks intervention
Title
stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)
Time Frame
after 6 weeks, 12 weeks intervention
Title
atopic manifestation
Description
incidence atopic dermatitis
Time Frame
within 1st year of life
Title
erythrocytes´ fatty acid profile
Description
palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)
Time Frame
after 6 weeks intervention
Title
calcium absorption
Description
urinary calcium-creatinin ratio, serum alkaline phosphatase
Time Frame
after 6 weeks, 12 weeks intervention

10. Eligibility

Sex
All
Maximum Age & Unit of Time
10 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Frank Jochum, MD
Organizational Affiliation
Waldkrankenhaus Protestant Hospital, Spandau
Official's Role
Principal Investigator
Facility Information:
Facility Name
Evangelisches Waldkrankenhaus Spandau
City
Berlin
ZIP/Postal Code
13589
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33934094
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.
Results Reference
derived
PubMed Identifier
32613402
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.
Results Reference
derived

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Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

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