Digestive Tolerance of Slightly Hydrolyzed Starter Infant Formula With Probiotics

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

COMPLETED

Clinical Phase

NA

Total Enrollment

480 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2012-04-30

Brief Summary

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

To demonstrate that infants have improved gut comfort when fed a slightly hydrolyzed starter formula containing probiotics compared to infants fed a control hydrolyzed and referenced non-hydrolyzed formula.

Related Clinical Trials

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

Probiotic Formula and Infant Growth

NCT01476397

Healthy

COMPLETED NA

The Effects on Growth of a Non-Routine Infant Formula

NCT00655720

Growth

COMPLETED NA

Gastrointestinal Tolerability of a Partially Hydrolyzed Ready-to-feed Infant Formula in Healthy Newborns

NCT05097924

Infant Nutritional Physiological Phenomena Infant Formula

COMPLETED

Gastrointestinal Tolerance Evaluation of an Infant Formula

NCT03307122

Healthy, Full-term Infants Who Are Formula-fed

COMPLETED NA

Gastrointestinal Tolerance of Infant Formula

NCT02322138

Gastrointestinal Tolerance

COMPLETED NA

Detailed Description

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

Infants often experience undesirable gastrointestinal effects, such as constipation, flatulence. These symptoms are often perceived by the parents as being related to the diet (formula) the baby is consuming. In another hand, infantile colic or fussing/crying is one of the most commonly encountered problems within the first three months of life. The etiology of the disorder remains unknown however, three main theories have been proposed to explain its origin: (i) psychological: due to inadequate mother-infant interaction (ii) gastrointestinal: such as hypertonicity and immaturity of the GI tract and Dietary factors that may influence the stool pattern in formula fed infants are (iii) allergic: due to a reaction against cow's milk protein or other food constituents. e.g. the protein source, the iron content, hydrolyzation of the protein, or the fat source.

It has been reported that infants receiving a casein predominant formula had less unformed stools than those receiving a whey predominant formula. Hydrolysation of protein resulted in reduced gastro-intestinal transit time and some studies using extensively hydrolyzed protein formula have shown more liquid stools.

A reduction of crying hours was also described in infant receiving an hydrolyzed formula. Some probiotics were reported with potential benefit on the gut comfort.

Conditions

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

Infant Nutrition

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

TREATMENT

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.