Infant Colic
Conditions
Keywords
Infant colic, Bifidobacterium breve, Lactobacillus fermentum
Brief summary
This study evaluates the efficacy of Bifidobacterium breve CECT7263 and the mixture B. breve CECT7263/Lactobacillus fermentum CECT5716 in the treatment of infant colic. Group 1 will receive B. breve CECT7263 (2x10E8 CFU/day) one dose per day, group 2 will receive B. breve CECT7263 (1x10E8 CFU/day) and L. fermentum CECT5716 (1x10E8 CFU/day) in one dose per day, group 3 (control group) will receive simethicone 20 mg 4 times a day.
Detailed description
Infant colic affects between 3-40% depending on the different criteria used for diagnosis. Recent studies carried out in healthy infants have shown that the consumption of B. breve CECT7263 and L. fermentum CECT5716 during the first months of life are related to a lower risk to present episodes of crying characteristic of infantile colic. The objective of the present study is to compare the effect of B. brevis and B. brevis\\L mixture. fermentum with respect to simethicone. It is a multicenter, controlled, randomized, blind, parallel-group, 4-weeks nutritional intervention study which will be conducted in 18 public and private hospitals and health centers from Spain.
Interventions
DIETARY_SUPPLEMENTB. breve
Bifidobacterium probiotic strain at 1E+08 cfu/day
DIETARY_SUPPLEMENTB. breve plus L. fermentum
Probiotic combination at 2E+08 cfu/day
DRUGSimethicone 20 MG
Standard treatment for infant colic
Sponsors
European Regional Development Fund
Ministerio de Ciencia e Innovación, Spain
Mónica Olivares Martín; PhD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The control group is the usual treatment that is administered differently (oral drops, 4 times a day) to the 2 research treatments (powder, 1 time a day).
Eligibility
Sex/Gender
ALL
Age
3 Weeks to 12 Weeks
Healthy volunteers
No
Inclusion criteria
* Infants from 3 to 12 weeks of age * Born at least at week 34 * Birth weight equal to or greater than 2000 grams * Fulfill the criteria of Rome III * Informed consent signed by parents or guardians
Exclusion criteria
* Failure to thrive * Antibiotic treatment less than 2 weeks before the study or during the study * Take probiotics as a treatment, different from the one that could contain the powdered infant formula * Abandon breastfeeding and switch to infant formula * Failure to comply with the study protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Crying time | 4 weeks | Crying time in minutes per day |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Responders to treatment on weeks 1, 2, 3 and 4 | 4 weeks | Number of responders to the treatment in each group on weeks 1, 2, 3 and 4. It is understood that responders are those infants who have experienced a daily decrease in the duration of the crises cries 50% above baseline |
| Gut microbiota | 4 weeks | Effect of the treatment on intestinal microbiota: the levels of Escherichia coli, Clostridium, Bacteroides, Lactobacillus and Bifidobacterium at the beginning and at the end of the study (weeks 0 and 4) will be analyzed by quantitative PCR. |
| Stool carbohydrates | 4 weeks | Stool carbohydrate levels: lactose and other carbohydrate levels will be analyzed by chromatography (Triple Quad LC/MS) at the beginning and end of the study (weeks 0 and 4). |
Countries
Spain
Outcome results
None listed