The aim of this study is to evaluate the effects of a probiotic formulation on the daily crying patterns of infants. It is hypothesized that participants given the probiotic formulation will show a significant reduction in daily crying duration compared to participants receiving the placebo.
Participants diagnosed with symptoms of infantile colic will be recruited to participate in this randomized, double-blind, placebo-controlled, two-arm parallel study. Eligible participants will be enrolled in this study for 6 weeks, and will undergo a 1-week run-in baseline period followed by a 4-week interventional period, then a 1-week follow-up period. The study will consist of 7 visits (V0 to V6): 4 in-person visits that alternate with 3 phone calls.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Participants will be asked to take one sachet daily, containing 1 billion CFU of the probiotic formula. Sachets must be dissolved in warm water or mother's milk before consumption.
Participants will be asked to take one sachet containing the placebo daily. Sachets must be dissolved in warm water or mother's milk before consumption.
Centro de Salud Cerro del Aire
Majadahonda, Madrid, Spain
Centro de Salud Ibiza
Madrid, Spain
Hospital Vithas La Milagrosa
Madrid, Spain
Centro de Salud Campo de la Paloma
Madrid, Spain
Hospital Vithas Aravaca
Symptoms of infantile colic
Comparison of the difference in the proportion of infants with reductions in mean daily crying duration by over 50 percent from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time frame: 5 weeks
Symptoms of infantile colic: Daily crying duration
Comparison of the average change from baseline in the mean daily crying duration between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time frame: 5 weeks
Symptoms of infantile colic: Number of crying episodes
Comparison of the change in the number of crying episodes from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time frame: 5 weeks
Symptoms of infantile colic: Sleep duration
Comparison of the difference in sleep duration from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time frame: 5 weeks
Symptoms of infantile colic: Time to a 25 and 50 percent reduction in cry/fuss time
Comparison of the difference in time to reach a 25 percent and 50 percent improvement in cry/fuss time from baseline between the probiotic and placebo groups, as assessed by the baby's Daily Diary.
Time frame: 5 weeks
Symptoms of infantile colic: Parental perception
Comparison of the difference in the perceived evolution of colic symptoms by parents of participants in the probiotic and placebo groups, as assessed by questions about the evolution of colic symptoms at visits 2 and 4.
Time frame: 5 weeks
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Madrid, Spain
Change in the mother's quality of life
Comparison of the changes in the overall score of the SF-36 from baseline (0 to 100; a higher score corresponds to a better quality of life), between mothers of participants in the probiotic and placebo groups.
Time frame: 5 weeks
Bowel movement frequency
Comparison of the changes in bowel movement frequency and consistency from baseline between the probiotic and placebo groups, as assessed by the Amsterdam Infant Stool Scale.
Time frame: 5 weeks
Fecal strain recovery of the probiotic
Presence of the probiotic strain in participants in the probiotic group, as determined by qPCR analysis of stool samples collected at baseline and at week 4.
Time frame: 5 weeks
Fecal microbiome composition
Comparison of the differences in the composition of fecal microbiota and mycobiota between the probiotic and placebo groups, as determined by 16S sequencing of stool samples collected at baseline and at week 4.
Time frame: 5 weeks