Infant Formula - Partially hydrolyzed protein for Colic

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
ColicInfant Formula - Partially hydrolyzed protein - Other
Eligibility
15 - 75
All Sexes
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Study Summary

This trial is testing whether a cow's milk protein infant formula can help reduce infant fussiness.

Treatment Effectiveness

Effectiveness Progress

1 of 3

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Study Objectives

0 Primary · 11 Secondary · Reporting Duration: Study Feeding Day 14 (+2 days) and Study Feeding Day 25 (+ 3 days)

Day 1
Medically confirmed adverse events
Day 25
Brief Infant Sleep Questionnaire
Day 25
Quality of Life Questionnaire
Day 25
Study Formula Intake
Study Feeding Days 8-28
Crying
Fussiness
Gassiness
Sleep
Spit-up
Stool consistency
Stool frequency

Trial Safety

Safety Progress

1 of 3

Similar Trials

2
DBV1605
1
Iron in infant formula
1
Experimental Toddler Drink

Trial Design

2 Treatment Groups

Cow's milk intact protein infant formula
1 of 2
Partially hydrolyzed cow's milk protein infant formula
1 of 2

Active Control

Experimental Treatment

142 Total Participants · 2 Treatment Groups

Primary Treatment: Infant Formula - Partially hydrolyzed protein · No Placebo Group · N/A

Partially hydrolyzed cow's milk protein infant formula
Other
Experimental Group · 1 Intervention: Infant Formula - Partially hydrolyzed protein · Intervention Types: Other
Cow's milk intact protein infant formula
Other
ActiveComparator Group · 1 Intervention: Infant Formula - Intact protein · Intervention Types: Other

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: study feeding day 14 (+2 days) and study feeding day 25 (+ 3 days)

Who is running the clinical trial?

Mead Johnson NutritionLead Sponsor
74 Previous Clinical Trials
15,199 Total Patients Enrolled
1 Trials studying Colic
30 Patients Enrolled for Colic

Eligibility Criteria

Age 15 - 75 · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have a singleton birth.
You are 37 weeks' gestational age or older.
You are receiving an intact protein infant formula for 7 days prior to Visit 1.
You are a student who is fed exclusively with study formula during the study period.
Parent(s) or legal guardian agrees not to enroll infant in another interventional clinical study while participating in this study.
You are between 2500 g (5 lbs 8 oz) and 4500 g (10 lbs 12 oz).
The baby is moderately fussy, very fussy, or extremely fussy at Visit 1.
References

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