Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age1-5
SponsorUniversity of Roma La Sapienza
About this trial
The goal of this clinical trial is to evaluate whether daily probiotic supplementation with Bifidobacterium bifidum (Bifipral® drops) can reduce crying time in formula-fed infants aged 5 months or younger diagnosed with infant colic (according to Rome IV criteria), with or without concomitant atopic dermatitis.
The main questions it aims to answer are:
* Does daily administration of B. bifidum for 8 weeks achieve at least a 50% reduction in average daily crying duration compared to placebo? * Does B. bifidum supplementation improve secondary outcomes, including crying frequency, sleep quality, bowel movement frequency, stool consistency, fecal microbiota composition, short-chain fatty acid (SCFA) levels, and SCORAD score in infants with atopic dermatitis? Researchers will compare formula-fed infants receiving Bifipral® drops (containing B. bifidum strains BFP19® and BFP29®) to a comparison group receiving an indistinguishable placebo to see if the probiotic safely improves colic symptoms and gut microbiota balance.
Participants will be asked to:
* Complete a 7-day observational run-in period to confirm eligibility and record baseline symptoms in a daily diary. * Administer 5 drops daily of the study product (probiotic or placebo) for 8 weeks. * Complete daily diaries tracking crying duration/frequency, sleep parameters, and bowel habits. * Attend 3 clinical visits (Baseline, Week 8, and a Safety Follow-up 2-4 weeks post-treatment). * Provide fecal samples at Baseline (Visit 1) and Week 8 (Visit 2) for microbiota profiling and SCFA analysis.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Non-breastfed infants aged ≤ 5 months diagnosed with infant colic according to Rome IV criteria, with or without atopic dermatitis.
Written informed consent from parents or legal guardians.
Disqualifiers
Age > 5 months.
Exclusive breastfeeding or mixed feeding.
Absence of infant colic diagnosis.
Presence of chronic diseases, neoplasms, immunodeficiencies, chronic infections, autoimmune diseases, IBD, celiac disease, genetic-metabolic disorders, cystic fibrosis or other chronic pulmonary diseases, cardiovascular/respiratory/GI malformations, neuropsychiatric disorders, neurological conditions, or vegetarian/vegan diet.
Trial design
Design model
Parallel
Treatments tested in this trial
Bifidobacterium bifidum BFP19® and BFP29® (Bifipral®)
Dietary supplementOral drops containing a combination of Bifidobacterium bifidum BFP19® and Bifidobacterium bifidum BFP29®. Administered at a dose of 5 drops once daily (providing a total of 4 x 10⁹ CFU/day, 2 x 10⁹ CFU per strain), preferably in the morning before feeding, for 8 weeks.
Placebo
Dietary supplementMatching placebo oral drops, indistinguishable from the active intervention in packaging, color, odor, taste, consistency, and labeling. Administered at a dose of 5 drops once daily, preferably in the morning before feeding, for 8 weeks.
Treatment groups
64 Participants
are divided into 2 treatment groupsGroup A: Active Probiotic Group (Bifipral®)Experimental treatment 1 intervention
Group B: Placebo Control GroupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Treatment Response Rate Based on Daily Crying Duration
Proportion of infants achieving a clinical response, defined as a \>/=50% reduction in the mean daily crying duration compared to baseline. Crying duration is recorded by parents in a structured daily diary. Baseline crying duration is calculated as the average of the values recorded during the 3 consecutive days preceding the baseline visit., in accordance with methodological standards of probiotic studies and Rome IV recommendations.
Time frame
Baseline (3-day run-in average) to Week 8 (end of treatment)Secondary outcomes
1
Change from Baseline in Daily Crying Episode Frequency
Change in the average number of crying episodes per 24-hour period, as recorded by parents in the structured daily behavioral diary.
Time frame
Baseline (3-day run-in average) to Week 8 (end of treatment)2
Change from Baseline in Total 24-Hour Sleep Duration
Change in total sleep duration over a 24-hour period (expressed in hours per day), calculated as the average of 3 consecutive days recorded by parents in the daily diary.
Time frame
Baseline (3-day run-in average) to Week 8 (end of treatment)3
Change from Baseline in Number of Nocturnal Awakenings
Change in the mean number of nocturnal awakenings per night, calculated as the average of 3 consecutive nights recorded by parents in the daily diary.
Time frame
Baseline (3-day run-in average) to Week 8 (end of treatment)4
Change from Baseline in Longest Uninterrupted Nighttime Sleep Episode
Change in the duration (expressed in hours) of the longest continuous nighttime sleep episode per night, calculated as the average of 3 consecutive nights recorded by parents in the daily diary.
Time frame
Baseline (3-day run-in average) to Week 8 (end of treatment)Sponsors and contacts
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Source ClinicalTrials.gov