Infants With Protein Sensitive Colitis

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

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-11-30

Study Completion Date

2001-02-28

Brief Summary

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

Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.

Related Clinical Trials

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

Tolerance of Healthy Term Infants Fed Infant Formulas

NCT00705562

Infant, Newborn

COMPLETED PHASE2

Tolerance of Healthy Term Infants Fed Infant Formulas #3

NCT00977964

Gastrointestinal Tolerance

COMPLETED PHASE3

Effect of Formula on Infant Behavior

NCT02746016

Gastrointestinal Tolerance

COMPLETED NA

Term Infants Fed a Partially Hydrolyzed Whey Protein-Based Formula

NCT04934397

Gastro-Intestinal Tolerance

TERMINATED NA

Formula Tolerance of Term Infants

NCT04915937

Gastro-Intestinal Tolerance

COMPLETED NA

Detailed Description

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

Conditions

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

Protein Sensitive Colitis

Study Design

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

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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

Experimental Infant Formula

Experimental formula to be fed ad libitum.

Group Type EXPERIMENTAL

Experimental Infant Formula

Intervention Type OTHER

Nutritionally complete free amino acid-based medical food.

Interventions

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

Experimental Infant Formula

Nutritionally complete free amino acid-based medical food.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

EleCare

Eligibility Criteria

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

Inclusion Criteria

* Less than or equal to 6 months of age
* 36-42 weeks gestational age at birth
* Singleton or Twin birth
* Diagnosed with protein sensitive colitis
* Negative stool culture at time of study entry
* No previous history of consuming free amino acid-based medical food
* Not receiving cisapride or steroids
* No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
* No milk or soy products for the duration of the study

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No