Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03877458 |
| Other study ID # |
CMUH105-REC1-155 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 16, 2017 |
| Est. completion date |
December 31, 2022 |
Study information
| Verified date |
March 2023 |
| Source |
China Medical University Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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, accompanied by bouts of fussiness and gas passing.
The etiology of infantile colic remains unclear; various theories have been proposed,
however, recent studies have implicated a potential role of the intestinal microbiome
,colicky infants presents lower amounts of Bifidobacteria and Lactobacilli. Several
randomized clinical trials (RCT) have been conducted to examine the effectiveness of
Lactobacillus reuteri DSM17938 vs placebo in the treatment of infantile colic. However, there
is no trial adopt probiotics contained Bifidobacteria and Lactobacilli to treat infantile
colic. In view of the above evidences, the investigators thus hypothesis that probiotics
contained Bifidobacteria and Lactobacilli will more effect to increase the diversity of
intestinal microbiome and alleviate infantile colic. The objective of this study is to
evaluate the efficacy of combine probiotics (L. acidophilus, B. longus and B. bifidus)
compare to Lactobacillus reuteri in the treatment infantile colic. Fecal calprotectin levels
and microbial community in colic infants before and after probiotics will be evaluated to
explore the mechanism of effectiveness of probiotics.
This, double-blind RCT will be carried out from December 2016 to November 2018 at Children's
hospital of China Medical university. Eligible infants are included in the study after
written informed consent is obtained from a parent/guardian. Study participants will meet the
following inclusion criteria: (1) 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; (2) age 3 weeks to 5 months at study commencement (although
infantile colic typically manifests between age 2 weeks and 3-4 months, to capture infants
with delayed onset of colic, infants with colic up to 6 months were eligible); (3)
exclusively breastfed; (4) term delivery (≥37 weeks gestation); and (5) healthy infants with
birth weight ≥2500 g. Exclusion criteria included: (1) a major medical problem or acute
illness, including gastroesophageal reflux, as determined by a pediatrician; (2) history of
antibiotic treatment before or during the study; (3) history of probiotic supplementation;
(4) history of any allergies to any of the ingredients in the probiotic mixture of
acidophilus, B longus and B. bifidus or placebo (sunflower oil, medium-chain triglyceride
oil, and silicon dioxide); and (5) concurrent participation in another clinical trial.
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
6months.
All participants are randomized into 1 of 3 treatment arms, the mixture L acidophilus, B
longus and B. bifidus group, Lactobacillus reuteri or placebo group. Independent Research
Support Pharmacy personnel, not participating in the study at the pharmacy of the Children
Hospital prepare a computer-generated 3-treatment randomization schedule with a random block
of varying size to ensure balance in the allocation of participants between treatment arms.
Stool bacterial microbiota will be accessed by next generation sequence and fecal
calprotectin will be measured by ELISA.
A minimum of 60 participants per study arm is needed to provide 80% power to detect an effect
size of 0.5 and a detectable difference between groups in mean crying and fussing times of 50
minutes. Statistical analyses are performed using SPSS version 20 (IBM, Armonk, New York)
using an intention-to-treat approach. The Student t test is used to compare mean values of
continuous variables approximating a normal distribution, and the Mann-Whitney U test is used
for nonnormally distributed variables. Proportions are compared using the χ2 test or Fisher
exact test, as appropriate. All reported statistical tests are 2-sided.
