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Combined Probiotics is More Effective in the Treatment of Infantile Colic

NCT03877458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 99

Last updated 2023-03-22

No results posted yet for this study

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.

Conditions

  • Infantile Colic

Interventions

OTHER

L. acidophilus TYCA06, B. longum BLI-02 and B. bifidum VDD088

Taking 1 mix probiotics capsule at bed time everyday for three months.

OTHER

L. reuteri GL-104

Taking 1 probiotic capsule at bed time everyday for three months.

OTHER

Placebo

Taking 1 placebo capsule at bed time everyday for three months.

Sponsors & Collaborators

  • China Medical University Hospital

    lead OTHER

Principal Investigators

  • Hung-chih Lin · China Medical University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
3 Weeks
Max Age
3 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-02-16
Primary Completion
2021-11-11
Completion
2022-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03877458 on ClinicalTrials.gov