N/A
N=80
Clinical Trial to Evaluate the Efficacy of Bifidobacterium BB-12® in the Treatment of Infantile Colic
Infantile Colic · Colic, Infantile
Bottom Line
View on ClinicalTrials.gov: NCT03434249 ↗Enrolled (actual)
80
Serious AEs
1.3%
Results posted
Jan 2020
Primary outcome: Primary: Number of Participants With >=50% Reduction in Mean Weekly Crying Duration — 32; 13; 3; 24 Participants — p=0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Bifidobacterium, BB-12® (Bifidolactis Infant) (Dietary_supplement); Bifidolactis Infant Placebo (Dietary_supplement)
- Age
- Pediatric
- Sex
- All
- Sponsor
- SOFAR S.p.A.
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With >=50% Reduction in Mean Weekly Crying Duration |
32; 13; 3; 24; 5; 3 | 0.0001 sig |
| SECONDARY Number of Crying Episodes |
7.92; 8.28; 3.15; 6.04 | 0.001 sig |
| SECONDARY Infectious Diseases Incidence |
0; 0 | — |
| SECONDARY Bowel Evacuation - Stool Frequency |
5.30; 5.61; 5.15; 5.50; 4.92; 5.35 | 0.001 sig |
| SECONDARY Bowel Evacuation - Stool Consistency |
0; 1; 14; 10; 21; 15 | — |
| SECONDARY Infant's Mood |
4; 5; 5; 6; 38; 25 | — |
| SECONDARY Infant's Sleep |
678.14; 693.62; 687.47; 696.68; 722.37; 711.99 | — |
| SECONDARY Infant's Temper |
158.82; 138; 118.61; 117.24; 89.48; 84.33 | — |
| SECONDARY Infant's Feeding |
187.72; 177.72; 186.13; 188.98; 179.80; 185.98 | — |
| SECONDARY Calprotectin |
667.76; 658.47; 802.64; 915.41 | — |
| SECONDARY Beta-defensin Type 2 |
73.50; 69.41; 166.34; 127.97 | — |
| SECONDARY LL37 Peptide |
5.50; 5.37; 7.65; 6.07 | — |
| SECONDARY Short Chain Fatty Acids - Butyrate |
0.19; 0.17; 0.63; 0.32 | — |
| SECONDARY Secretory Immunoglobulin A (SIgA) |
84.79; 86.55; 250.65; 192.01 | — |
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.
Eligibility Criteria
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 < 7.
- 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.
Data sourced from ClinicalTrials.gov (NCT03434249). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.