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Completed

NCT Number: NCT01603719

Efficacy and Safety of an Infant Formula With Milkfat and Prebiotics

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.

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Key information

Conditions

Infections Constipation Food Intolerance Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Stool Biochemistry Stool Flora

Age range

Up to 10 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

new infant formula with prebiotics and beta-palmitate

Dietary Supplement

experimental infant formula as sole source of nutrition over first 12 weeks of life

Primary outcomes

  1. number of gastrointestinal infections

    Time frame: within first year of life

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Waldkrankenhaus Protestant Hospital, Spandau

Other

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2014
Study completion
2020
First posted
May 23, 2012
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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