NCT01603719

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 23, 2012

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

3.2 years

First QC Date

May 15, 2012

Last Update Submit

June 5, 2020

Conditions

InfectionsStool FloraStool BiochemistryConstipationFood Intolerance

Keywords

infant formulaprebioticsbeta-palmitatestool florabifidogenic

Outcome Measures

Primary Outcomes (1)

  • number of gastrointestinal infections

    within first year of life

Secondary Outcomes (8)

  • proportion of bifidobacteria on total stool bacteria

    after 6 and 12 weeks intervention

  • number of infectious episodes (gastrointestinal, respiratory, fever episodes)

    within first year of life

  • anthropometric parameters (gain in weight, length, head circumference)

    after 6 weeks, after 12 weeks intervention

  • symptoms of food intolerance, constipation, colics

    after 6 weeks, 12 weeks intervention

  • stool biochemistry (calcium-fatty acid soaps, short chain fatty acids content in the stools)

    after 6 weeks, 12 weeks intervention

  • +3 more secondary outcomes

Study Arms (2)

Standard Formula

NO INTERVENTION

Standard formula with no supplementation

experimental formula

EXPERIMENTAL

infant formula with higher beta-palmitate and supplemented GOS

Dietary Supplement: new infant formula with prebiotics and beta-palmitate

Interventions

new infant formula with prebiotics and beta-palmitateDIETARY_SUPPLEMENT

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

experimental formula

Eligibility Criteria

AgeUp to 10 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • healthy term neonates
  • gestational age 37 to 42 weeks
  • birth weight 10th to 90th percentile (Voigt reference)
  • infants being exclusively formula-fed at enrollment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Evangelisches Waldkrankenhaus Spandau

Berlin, 13589, Germany

Location

Related Publications (2)

  • Lambidou M, Alteheld B, Fimmers R, Jochum F, Nomayo A, Stehle P. Impact of an Infant Formula Containing a Novel Fat Blend (Cow's Milk Fat, Fish and Vegetable Oil) and Prebiotics on Stool Fatty Acid Soaps and Erythrocyte Fatty Acid Profiles in Full-Term Healthy Newborns. Ann Nutr Metab. 2021;77(3):138-145. doi: 10.1159/000515705. Epub 2021 Apr 30.

    PMID: 33934094DERIVED

  • Nomayo A, Schwiertz A, Rossi R, Timme K, Foster J, Zelenka R, Tvrdik J, Jochum F. Infant formula with cow's milk fat and prebiotics affects intestinal flora, but not the incidence of infections during infancy in a double-blind randomized controlled trial. Mol Cell Pediatr. 2020 Jul 2;7(1):6. doi: 10.1186/s40348-020-00098-1.

    PMID: 32613402DERIVED

MeSH Terms

Conditions

InfectionsConstipationFood Intolerance

Interventions

Prebiotics

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary FiberDietary CarbohydratesCarbohydratesPolysaccharides, BacterialPolysaccharidesFoodDiet, Food, and NutritionPhysiological PhenomenaDietary SupplementsFood and Beverages

Study Officials

  • Frank Jochum, MD

    Waldkrankenhaus Protestant Hospital, Spandau

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 23, 2012

Study Start

August 1, 2011

Primary Completion

October 1, 2014

Study Completion

January 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06

Locations

DE(1)