Infant Formula With Partially Hydrolyzed Cow's Milk Protein Versus a Formula With Intact Protein

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-19

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Study to Investigate the Effects of an Infant Formula Containing Partially Hydrolysed Proteins on Growth, Safety and Tolerance in Healthy Term Infants

NCT03062761

Growth

COMPLETED PHASE2

Evaluation of Safety and Efficacy of New Infant Formula in Infantile Colic

NCT01721850

Infantile Colic

TERMINATED NA

Randomised, Controlled Study to Assess Safety and Tolerance of Infant Formula With Prebiotics and Postbiotics in Healthy Infants.

NCT04015050

Healthy Term Infants

COMPLETED NA

Growth, Safety and Tolerance of a Hydrolyzed Protein Infant Formula

NCT05618704

Cow Milk Allergy

COMPLETED NA

Tolerance of an Extensively Hydrolyzed Protein Infant Formula Versus a Premature Infant Formula

NCT01987154

Feeding Intolerance

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Demonstrate that an infant formula with partially hydrolized cow's milk protein of serum proteins is equivalent to an intact protein formula in healthy children in terms of safety of use and suitability, to prove that it can be a alternative with digestive health benefits in healthy children with infant colic.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infant Colic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Partially hydrolyzed formula (pHF)

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

Group Type EXPERIMENTAL

Partially hydrolyzed formula (pHF)

Intervention Type DIETARY_SUPPLEMENT

Infant formula with partially hydrolyzed protein

Standard formula (SF)

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

Group Type ACTIVE_COMPARATOR

Standard formula (SF)

Intervention Type DIETARY_SUPPLEMENT

Infant formula with intact protein

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Partially hydrolyzed formula (pHF)

Infant formula with partially hydrolyzed protein

Intervention Type DIETARY_SUPPLEMENT

Standard formula (SF)

Infant formula with intact protein

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Children diagnosed as nursing colic according to Roma IV criteria.
* Infants who have received breastfeeding at least 2 weeks.
* Infants who at the time of inclusion in the study whose parents/legal guardians voluntarily decide not to continue exclusive breastfeeding or only maintain it in residual form (less than 20% of the daily intake, one breast intake per day).
* 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.

Exclusion Criteria

* 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.

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No