Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

Constipation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01603719
• Other study ID #: EWK-001
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: January 2020

Study information

• Verified date: June 2020
• Source: Waldkrankenhaus Protestant Hospital, Spandau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: January 2020
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 10 Days

Eligibility

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

Related Conditions & MeSH terms

• Constipation
• Food Intolerance
• Infections
• Stool Biochemistry
• Stool Flora

Intervention

Dietary Supplement:
• new infant formula with prebiotics and beta-palmitate
experimental infant formula as sole source of nutrition over first 12 weeks of life

Locations

Country	Name	City	State
Germany	Evangelisches Waldkrankenhaus Spandau	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Waldkrankenhaus Protestant Hospital, Spandau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of gastrointestinal infections		within first year of life
Secondary	proportion of bifidobacteria on total stool bacteria		after 6 and 12 weeks intervention
Secondary	number of infectious episodes (gastrointestinal, respiratory, fever episodes)		within first year of life
Secondary	anthropometric parameters (gain in weight, length, head circumference)		after 6 weeks, after 12 weeks intervention
Secondary	symptoms of food intolerance, constipation, colics	number of episodes with colics, vomiting, abdominal bloating, intestinal gas; stool frequency, stool consistency, constipation	after 6 weeks, 12 weeks intervention
Secondary	stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)		after 6 weeks, 12 weeks intervention
Secondary	atopic manifestation	incidence atopic dermatitis	within 1st year of life
Secondary	erythrocytes´ fatty acid profile	palmitic acid, linolic acid, alpha-linoleic acid, AA, DHA, EPA etc content (erythrocytes membrane)	after 6 weeks intervention
Secondary	calcium absorption	urinary calcium-creatinin ratio, serum alkaline phosphatase	after 6 weeks, 12 weeks intervention