Studio Clinico Randomizzato Per Valutare l'Efficacia Del Bifidobacterium BB-12® Nel Trattamento Delle Coliche Infantili
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 80
- Locations
- 2
- Primary Endpoint
- Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Study Overview
Brief Summary
This is a single-center, randomized, double blind controlled study to investigate the effects of Bifidobacterium, BB-12® versus placebo in a study group of pediatric patients with infantile colic.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- — to 7 Weeks (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients are included in the study if they meet all the following criteria:
- •Exclusively breastfed healthy infants of both sexes, aged ≤ 7 weeks.
- •Diagnosis of IC according to Rome III criteria.
- •Written informed consent of the parent/tutor.
Exclusion Criteria
- •Patients are excluded from this study if they meet any of the following criteria:
- •Birth weight < 2500 g.
- •Gestational age < 37 weeks.
- •APGAR 5 minutes <
- •Formula feeding.
- •Stunting/loss of weight (< 100 g/weeks from birth to the last reported weight).
- •Neurological diseases.
- •Known or suspected food allergy.
- •Gastroesophageal reflux disease.
- •Use of substances that alter gut microbiota (probiotics, prebiotics, antibiotics, gastric acidity inhibitors) in the last 2 weeks prior the enrollment.
- •History of fever and/or infectious diseases in the last 2 weeks prior to enrollment.
- •Ongoing systemic infections.
- •History of congenital infections.
- •Chronic intestinal diseases (cystic fibrosis or other forms of primitive pancreatic insufficiency)
- •Primitive or secondary malformations of the gastrointestinal tract (such as esophageal atresia, intestinal atresia, short bowel syndrome, malrotation).
- •Metabolic diseases.
- •Genetic diseases and chromosomal abnormalities.
- •Primary or secondary immunodeficiencies.
- •Not sufficient reliability or presence of conditions that may result in non-compliance/adherence of the patient to the Protocol.
- •Previous participation in this study.
Outcomes
Primary Outcomes
Number of Participants With >=50% Reduction in Mean Weekly Crying Duration
Time Frame: at 28 days from the baseline (Visit T5)
Treatment success rate was evaluated in terms of reduction of crying duration, comparing mean weekly duration of the last Week (from T4 to T5) and mean weekly duration of Week 1 (from T0 to T1). The daily number and duration of crying episodes has been collected in the 'Evaluation of crying' section of the patient diary. Weekly mean is defined as the mean of the calculated average daily durations during the selected week and is described by means of descriptive statistics for continuous data. Mean changes from baseline (i.e. mean of the first Week) to the mean of the selected week will be computed as well. The following categories of patients has been defined: Success = patients who meet the criteria for the treatment success rate No Success = patients who do not meet the criteria for the treatment success rate Missing = patients who did not do the last visit (Visit T5 - at 28 days from baseline)
Secondary Outcomes
- Infant's Temper(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Infant's Feeding(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Calprotectin(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))
- Number of Crying Episodes(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))
- Infant's Mood(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Infectious Diseases Incidence(at each visit, for 5 weeks starting from the enrollment in the study (Visit T0, T1, T2, T3, T4 and T5))
- Bowel Evacuation - Stool Frequency(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Beta-defensin Type 2(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))
- LL37 Peptide(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))
- Bowel Evacuation - Stool Consistency(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Infant's Sleep(at each weekly visit from baseline (Visit T1, T2, T3, T4 and T5))
- Short Chain Fatty Acids - Butyrate(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))
- Secretory Immunoglobulin A (SIgA)(at 7 days (Visit T1 - baseline) and 28 days from the baseline (Visit T5))