NCT07754968 Use of Bifidobacterium Bifidum in Formula-Fed Infants With Colic, With or Without Atopic Dermatitis
| NCT ID | NCT07754968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Roma La Sapienza |
| Condition | Infant Colic |
| Study Type | INTERVENTIONAL |
| Enrollment | 64 participants |
| Start Date | 2026-07-01 |
| Primary Completion | 2028-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 64 participants in total. It began in 2026-07-01 with a primary completion date of 2028-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Giovanni Di Nardo, Professor
PRINCIPAL INVESTIGATOR
UOC Pediatrics, AOU Sant'Andrea, Rome / Sapienza University of Rome
Frequently Asked Questions
Who can join the NCT07754968 clinical trial?
This trial is open to participants of all sexes, aged 1 Week or older, up to 5 Months, studying Infant Colic. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07754968 currently recruiting?
Yes, NCT07754968 is actively recruiting participants. Contact the research team at giovanni.dinardo@uniroma1.it for enrollment information.
Where is the NCT07754968 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07754968 clinical trial?
NCT07754968 is sponsored by University of Roma La Sapienza. The principal investigator is Giovanni Di Nardo, Professor at UOC Pediatrics, AOU Sant'Andrea, Rome / Sapienza University of Rome. The trial plans to enroll 64 participants.