Status:
COMPLETED
Combined Probiotics is More Effective in the Treatment of Infantile Colic
Lead Sponsor:
China Medical University Hospital
Conditions:
Infantile Colic
Eligibility:
All Genders
3-3 years
Phase:
NA
Brief Summary
All participants are randomized into 1 of 3 treatment arms, the mixture L acidophilus, B longum and B. bifidum group, Lactobacillus reuteri or placebo group. Primary outcome is defined as a reduction...
Detailed Description
Infantile colic or excessive infant crying with no medical cause is a burdensome condition. Although crying is often considered "normal behavior," 5%-40% of infants cry inconsolably and excessively, a...
Eligibility Criteria
Inclusion
- Diagnosis of infantile colic (ie, crying or fussy/gassy episodes ≥3 hours/day for ≥3 days/7 days, as defined by a modified definition of Wessel criteria) at study commencement.
- Age 3 weeks to 3 months at study commencement.
- Infants are born in full term (greater than 37 weeks) and the birth weight more than 2500 grams.
Exclusion
- A major medical problem or acute illness, including gastroesophageal reflux, as determined by a pediatrician.
- History of antibiotic treatment before or during the study.
- History of probiotic supplementation.
- History of any allergies to any of the ingredients in the probiotic mixture of L. acidophilus, B. longum and B. bifidum or placebo.
- Concurrent participation in another clinical trial.
Key Trial Info
Start Date :
February 16 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT03877458
Start Date
February 16 2017
End Date
December 31 2022
Last Update
March 22 2023
Active Locations (1)
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1
China Medical University Hospital
Taichung, Taiwan, 40447