NCT04015089

Brief Summary

Randomized, parallel, double-blind clinical trial, comparing a partially hydrolyzed serum proteins infant formula with a conventional formula with intact protein in healthy infants that suffer from colic

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
156

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

July 19, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 10, 2019

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 18, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

July 8, 2019

Last Update Submit

September 17, 2020

Conditions

Infant Colic

Keywords

Infant formulaPartially hydrolized protein infant formula

Outcome Measures

Primary Outcomes (2)

  • Growth standard calculated z-scores

    Using Z-scores including: weight (g), size (cm) and cranial perimeter (cm)

    From baseline to 3 months after starting with the formula

  • Symptoms associated with infant colic

    Hours of crying, wakefulness, sleep for 24 hours, by adapting Barr's crying letter

    From baseline to 3 months after starting with the formula

Secondary Outcomes (7)

  • Growth standard calculated z-scores

    At 6, 9 and 12 months old.

  • Gatrointestinal tolerance recording

    Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old

  • Infant illness and infection outcomes

    Baseline, 1, 2 and 3 months follow-up visit, and 6, 9 months old

  • Behaviour/temperament test

    1, 6, 12 months old

  • Assessment of supplementary food

    At 6 and 9 months old

  • +2 more secondary outcomes

Study Arms (2)

Partially hydrolyzed formula (pHF)

EXPERIMENTAL

Infants fed exclusively with a infant formula based on partially hydrolyzed serum cow's milk proteins.

Dietary Supplement: Partially hydrolyzed formula (pHF)

Standard formula (SF)

ACTIVE COMPARATOR

Infants fed exclusively with a standard formula based on intact cow's milk proteins

Dietary Supplement: Standard formula (SF)

Interventions

Partially hydrolyzed formula (pHF)DIETARY_SUPPLEMENT

Infant formula with partially hydrolyzed protein

Partially hydrolyzed formula (pHF)
Standard formula (SF)DIETARY_SUPPLEMENT

Infant formula with intact protein

Standard formula (SF)

Eligibility Criteria

Age2 Weeks - 8 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Children diagnosed as nursing colic according to Roma IV criteria.
  • Infants who have received breastfeeding at least 2 weeks.
  • Full-term infants (\>37 weeks of gestation).
  • Infants with weight suitable for their gestational age (2500-4500g).
  • Normal APGAR score: 7-10.
  • Infants between 2 and 8 weeks of life.
  • Infants whose parents/legal guardians have signed informed consent.
  • Infants with good availability of clinical follow-up until the end of the study.

You may not qualify if:

  • Infants fed from birth with exclusive infant formula.
  • Infants with congenital diseases or malformations that may affect growth.
  • Infants with major medical conditions that require chronic medication or close medical checks.
  • Infants who have taken any type of antibiotics or probiotics prior to the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Consorci Sanitari de Terrassa

Terrassa, Barcelona, 08227, Spain

RECRUITING

Fundació Hospital de Nens

Barcelona, 08009, Spain

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Benjamin Martin Martínez

    Consorci Sanitari de Terrassa

    PRINCIPAL INVESTIGATOR

  • Gemma Colomé Rivero

    Fundació Hospital de Nens de Barcelona

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Roser De Castellar, MD

CONTACT

+34 902105243Roser.DeCastellar@ordesa.es

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2019

First Posted

July 10, 2019

Study Start

July 19, 2018

Primary Completion

December 1, 2020

Study Completion

December 1, 2020

Last Updated

September 18, 2020

Record last verified: 2020-09

Locations

ES(2)