Combined Probiotics is More Effective in the Treatment of Infantile Colic
1 other identifier
interventional
99
1 country
1
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 in the duration of average crying and fussing times, from baseline (day 0) to age 6 months, to \<3 hours per day. Secondary outcome are the number of participants who respond to treatment on days 7, 14, 21, 28 and each month till age 6 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 16, 2017
CompletedFirst Submitted
Initial submission to the registry
March 12, 2019
CompletedFirst Posted
Study publicly available on registry
March 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 11, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedMarch 22, 2023
March 1, 2023
4.7 years
March 12, 2019
March 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Average crying and fussing times.
Change in the duration of average crying and fussing times from baseline (day 0) to age 6 months, to \<3 hours per day.
6 months.
Secondary Outcomes (1)
The number of participants.
6 months.
Study Arms (3)
L. acidophilus TYCA06, B. longum BLI-02 and B. bifidum VDD088
EXPERIMENTALTaking 1 mix probiotics capsule at bed time everyday for three months.
L. reuteri GL-104
EXPERIMENTALTaking 1 probiotic capsule at bed time everyday for three months.
Placebo group
PLACEBO COMPARATORTaking 1 Placebo capsule at bed time everyday for three months.
Interventions
Taking 1 mix probiotics capsule at bed time everyday for three months.
Taking 1 probiotic capsule at bed time everyday for three months.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
China Medical University Hospital
Taichung, 40447, Taiwan
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Hung-chih Lin
China Medical University Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician
Study Record Dates
First Submitted
March 12, 2019
First Posted
March 15, 2019
Study Start
February 16, 2017
Primary Completion
November 11, 2021
Study Completion
December 31, 2022
Last Updated
March 22, 2023
Record last verified: 2023-03