Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01603719
Recruitment Status : Unknown
Verified December 2015 by Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau.
Recruitment status was:  Active, not recruiting
First Posted : May 23, 2012
Last Update Posted : December 18, 2015
Information provided by (Responsible Party):
Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau

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.

Condition or disease Intervention/treatment Phase
Infections Stool Flora Stool Biochemistry Constipation Food Intolerance Dietary Supplement: new infant formula with prebiotics and beta-palmitate Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : August 2011
Actual Primary Completion Date : October 2014
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. number of gastrointestinal infections [ Time Frame: within first year of life ]

Secondary Outcome Measures :
  1. proportion of bifidobacteria on total stool bacteria [ Time Frame: after 6 and 12 weeks intervention ]
  2. number of infectious episodes (gastrointestinal, respiratory, fever episodes) [ Time Frame: within first year of life ]
  3. anthropometric parameters (gain in weight, length, head circumference) [ Time Frame: after 6 weeks, after 12 weeks intervention ]
  4. symptoms of food intolerance, constipation, colics [ Time Frame: after 6 weeks, 12 weeks intervention ]
    number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation

  5. stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools) [ Time Frame: after 6 weeks, 12 weeks intervention ]
  6. atopic manifestation [ Time Frame: within 1st year of life ]
    incidence atopic dermatitis

  7. erythrocytes´ fatty acid profile [ Time Frame: after 6 weeks intervention ]
    palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)

  8. calcium absorption [ Time Frame: after 6 weeks, 12 weeks intervention ]
    urinary calcium-creatinin ratio, serum alkaline phosphatase

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Ages Eligible for Study:   up to 10 Days   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01603719

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

Responsible Party: Dr. Antonia Nomayo, MD, Waldkrankenhaus Protestant Hospital, Spandau Identifier: NCT01603719     History of Changes
Other Study ID Numbers: EWK-001
First Posted: May 23, 2012    Key Record Dates
Last Update Posted: December 18, 2015
Last Verified: December 2015

Keywords provided by Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau:
infant formula
stool flora

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