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Efficacy of Bifidobacterium Bifidum on Symptoms of Infant Colic and Atopic Dermatitis: a Randomized Controlled Trial.

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 7 days
Maximum Age: 5 months
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Italy
AOU Sant'Andrea
RECRUITING
Roma
Contact Information
Primary
Giovanni Di Nardo, Professor
giovanni.dinardo@uniroma1.it
0633775870
Backup
Maurizio Mennini, MD
dott.mauriziomennini@gmail.com
+39 0633775780
Time Frame
Start Date: 2026-07-01
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 64
Treatments
Experimental: Active Probiotic Group (Bifipral®)
Non-breastfed infants receiving oral drops containing a probiotic blend of Bifidobacterium bifidum BFP19® and Bifidobacterium bifidum BFP29® (Bifipral®) daily for 8 weeks.
Placebo_comparator: Placebo Control Group
Non-breastfed infants receiving oral drops of an indistinguishable placebo daily for 8 weeks.
Related Therapeutic Areas
Sponsors
Leads: University of Roma La Sapienza

This content was sourced from clinicaltrials.gov

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