Effect of a Prebiotic on Colic and Crying and Fussing Behaviour in Infants

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

TERMINATED

Clinical Phase

NA

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-13

Study Completion Date

2019-08-15

Brief Summary

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

Colic, or inconsolable crying and fussing, affects around 20% of babies who are 3 months of age or younger. To date, there are no known treatments that have been found to help reduce colic and its symptoms in babies. The investigators would like to see whether a baby formula that contains a prebiotic will lead to the same improvements in babies with colic. The investigators will test this by giving some babies a formula with the prebiotic and other babies a placebo formula.

Related Clinical Trials

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

Feeding Intervention for Infants With Crying

NCT01017991

Crying

TERMINATED NA

Effect of Formula on Infant Behavior

NCT02746016

Gastrointestinal Tolerance

COMPLETED NA

Efficacy of a Partially Hydrolyzed Formula, Containing Lactobacillus Reuteri, for Infant Colic

NCT02813772

Infant Colics

UNKNOWN NA

Formula Tolerance of Term Infants

NCT04915937

Gastro-Intestinal Tolerance

COMPLETED NA

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

NCT04015089

Infant Colic

UNKNOWN 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.

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

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.

Experimental Infant Formula

Milk-based infant formula with prebiotics

Group Type ACTIVE_COMPARATOR

Experimental Infant formula

Intervention Type OTHER

Ready-to-feed infant formula to be fed ad libitum

Reference group

Milk-based infant formula without prebiotics

Group Type PLACEBO_COMPARATOR

Reference group

Intervention Type OTHER

Ready-to-feed infant formula to be fed ad libitum

Interventions

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

Experimental Infant formula

Ready-to-feed infant formula to be fed ad libitum

Intervention Type OTHER

Reference group

Ready-to-feed infant formula to be fed ad libitum

Intervention Type OTHER

Eligibility Criteria

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

Inclusion Criteria

* Healthy, term infant from a singleton birth (=\>37 weeks gestational age); formula fed; primary caregiver able to read and write in English; current colicky behaviour

Exclusion Criteria

* Infants with known genetic syndromes; birth weight (\<2500g); use of proton pump inhibitors; use of antibiotics in previous week; use of nutritional colic remedies; use of probiotics; maternal medical history of diabetes (excluding gestational diabetes), tuberculosis, or any perinatal infection while pregnant with child enrolled in study; presence of blood in infant stool sample; possible cow milk protein allergy

Minimum Eligible Age

2 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No