Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau
ClinicalTrials.gov Identifier:
First received: May 15, 2012
Last updated: December 17, 2015
Last verified: December 2015
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.

Condition Intervention
Stool Flora
Stool Biochemistry
Food Intolerance
Dietary Supplement: new infant formula with prebiotics and beta-palmitate

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Waldkrankenhaus Protestant Hospital, Spandau:

Primary Outcome Measures:
  • number of gastrointestinal infections [ Time Frame: within first year of life ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • proportion of bifidobacteria on total stool bacteria [ Time Frame: after 6 and 12 weeks intervention ] [ Designated as safety issue: No ]
  • number of infectious episodes (gastrointestinal, respiratory, fever episodes) [ Time Frame: within first year of life ] [ Designated as safety issue: No ]
  • anthropometric parameters (gain in weight, length, head circumference) [ Time Frame: after 6 weeks, after 12 weeks intervention ] [ Designated as safety issue: Yes ]
  • symptoms of food intolerance, constipation, colics [ Time Frame: after 6 weeks, 12 weeks intervention ] [ Designated as safety issue: No ]
    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) [ Time Frame: after 6 weeks, 12 weeks intervention ] [ Designated as safety issue: No ]
  • atopic manifestation [ Time Frame: within 1st year of life ] [ Designated as safety issue: No ]
    incidence atopic dermatitis

  • erythrocytes´ fatty acid profile [ Time Frame: after 6 weeks intervention ] [ Designated as safety issue: Yes ]
    palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)

  • calcium absorption [ Time Frame: after 6 weeks, 12 weeks intervention ] [ Designated as safety issue: No ]
    urinary calcium-creatinin ratio, serum alkaline phosphatase

Estimated Enrollment: 102
Study Start Date: August 2011
Estimated Study Completion Date: May 2016
Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Standard Formula
Standard formula with no supplementation
Experimental: experimental formula
infant formula with higher beta-palmitate and supplemented GOS
Dietary Supplement: new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life

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.


Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01603719

Evangelisches Waldkrankenhaus Spandau
Berlin, Germany, 13589
Sponsors and Collaborators
Waldkrankenhaus Protestant Hospital, Spandau
Principal Investigator: Frank Jochum, MD Waldkrankenhaus Protestant Hospital, Spandau
  More Information

Responsible Party: Dr. Antonia Nomayo, MD, Waldkrankenhaus Protestant Hospital, Spandau
ClinicalTrials.gov Identifier: NCT01603719     History of Changes
Other Study ID Numbers: EWK-001 
Study First Received: May 15, 2012
Last Updated: December 17, 2015
Health Authority: Ethics Commission: Aerztekammer Berlin, Germany

Keywords provided by Waldkrankenhaus Protestant Hospital, Spandau:
infant formula
stool flora

Additional relevant MeSH terms:
Signs and Symptoms
Signs and Symptoms, Digestive

ClinicalTrials.gov processed this record on May 23, 2016