We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2015 by Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01603719
First Posted: May 23, 2012
Last Update Posted: December 18, 2015
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.
Information provided by (Responsible Party):
Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau
May 15, 2012
May 23, 2012
December 18, 2015
August 2011
October 2014   (Final data collection date for primary outcome measure)
number of gastrointestinal infections [ Time Frame: within first year of life ]
Same as current
Complete list of historical versions of study NCT01603719 on ClinicalTrials.gov Archive Site
  • proportion of bifidobacteria on total stool bacteria [ Time Frame: after 6 and 12 weeks intervention ]
  • number of infectious episodes (gastrointestinal, respiratory, fever episodes) [ Time Frame: within first year of life ]
  • anthropometric parameters (gain in weight, length, head circumference) [ Time Frame: after 6 weeks, after 12 weeks intervention ]
  • 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
  • stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools) [ Time Frame: after 6 weeks, 12 weeks intervention ]
  • atopic manifestation [ Time Frame: within 1st year of life ]
    incidence atopic dermatitis
  • erythrocytes´ fatty acid profile [ Time Frame: after 6 weeks intervention ]
    palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)
  • calcium absorption [ Time Frame: after 6 weeks, 12 weeks intervention ]
    urinary calcium-creatinin ratio, serum alkaline phosphatase
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics
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
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
  • Infections
  • Stool Flora
  • Stool Biochemistry
  • Constipation
  • Food Intolerance
Dietary Supplement: new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life
  • No Intervention: Standard Formula
    Standard formula with no supplementation
  • Experimental: experimental formula
    infant formula with higher beta-palmitate and supplemented GOS
    Intervention: Dietary Supplement: new infant formula with prebiotics and beta-palmitate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
102
May 2016
October 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
up to 10 Days   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT01603719
EWK-001
No
Not Provided
Not Provided
Dr. Antonia Nomayo, Waldkrankenhaus Protestant Hospital, Spandau
Waldkrankenhaus Protestant Hospital, Spandau
Not Provided
Principal Investigator: Frank Jochum, MD Waldkrankenhaus Protestant Hospital, Spandau
Waldkrankenhaus Protestant Hospital, Spandau
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP