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Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

This study is currently recruiting participants.
Verified May 2012 by Waldkrankenhaus Protestant Hospital, Spandau
Sponsor:
Information provided by (Responsible Party):
Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau
ClinicalTrials.gov Identifier:
NCT01603719
First received: May 15, 2012
Last updated: May 18, 2012
Last verified: May 2012
History of Changes
  Purpose

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
Infections
Stool Flora
Stool Biochemistry
Constipation
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:

U.S. FDA Resources

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: August 2013
Estimated Primary Completion Date: January 2013 (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.

  Eligibility

Ages Eligible for Study:   up to 10 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01603719

Locations
Germany
Evangelisches Waldkrankenhaus Spandau Recruiting
Berlin, Germany, 13589
Contact: Antonia Nomayo, MD     0049 30 3702 ext 2289     a.nomayo@waldkrankenhaus.com    
Sponsors and Collaborators
Waldkrankenhaus Protestant Hospital, Spandau
Investigators
Principal Investigator: Frank Jochum, MD Waldkrankenhaus Protestant Hospital, Spandau
  More Information

No publications provided

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: May 18, 2012
Health Authority: Ethics Commission: Aerztekammer Berlin, Germany

Keywords provided by Waldkrankenhaus Protestant Hospital, Spandau:
infant formula
prebiotics
beta-palmitate
stool flora
bifidogenic

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

ClinicalTrials.gov processed this record on May 23, 2013