A Phase 2 interventional study of Probiotic Formulation and Placebo in Colic, sponsored by Lallemand Health Solutions. Withdrawn at 5 sites in Spain. Open to participants aged Up to 8 Weeks. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Lallemand Health Solutions · Phase 2, Interventional, and Supportive care
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.
148 studies on the registry are indexed under Colic; 21 are open to participants now.
Browse Colic studies →Lallemand Health Solutions is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants in this group will be randomized to receive the probiotic formulation for 4 weeks.
Dietary Supplement: Probiotic Formulation
Participants in this group will be randomized to receive the placebo for 4 weeks.
Dietary Supplement: Placebo
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.
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
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
Fecal protein markers
Comparison of the differences in the concentration of fecal protein markers between probiotic and placebo groups in stool samples collected at baseline and at week 4. Proteins will be quantified using immunoassay methods.
Time frame: 5 weeks
Incidence of Adverse Events
Comparison of the number of adverse events (AEs) and serious adverse events (SAEs) recorded in the probiotic and placebo groups.
Time frame: 6 weeks
Plan to share: No — After publications of the results, de-identified data will be shared with qualified researchers and scientists upon reasonable request to the sponsor including a detailed proposal of the intended use of the data, as per the Lallemand Health Solutions Inc. Policy on Clinical Trial Transparency and Data Sharing (available upon request).
No publications or documents are linked to this record.
This study is withdrawn, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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