Infant Colic
Conditions
Keywords
Infant colic, probiotic
Brief summary
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
Detailed description
Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula). Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events. Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.
Interventions
DIETARY_SUPPLEMENTAB-Kolicare
Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 for 21 days, 5 drops/day preferably during the first intake of milk
DIETARY_SUPPLEMENTReuteri gotas
Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
Sponsors
AB Biotics, SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.
Intervention model description
Randomized, multicentric, single-blind trial in infants between 2 and 12 weeks of age diagnosed with infant colic, who will be allocated to receive one of the two comercialized probiotic products B. Longum and P. Pentosaceus (branch one) or L. Reuteri (branch two) for 21 days
Eligibility
Sex/Gender
ALL
Age
2 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants from 2 to 12 weeks of age * Infants diagnosed with infant colic following Roma IV criteria for clinical research * Gestational age greater or equal to 37 weeks * Birth weight greater than 2100 g * Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.
Exclusion criteria
* Infants that are fed with solid food. * Infants whose parents can not appropriately follow the requirements of the study. * Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study. * Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study. * Infants fed extensively hydrolyzed infant formula * Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone. * Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of crying and fussing | 21 days | Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day. |
| Percent of responders | 7, 14, 21 days | Percent of subjects whose change in crying time is equal or larger than 50% from baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of regurgitations | 21 days | Change in daily number of regurgitations |
| Bowel movements | 21 days | Change in daily number of bowel movements |
| Food intake | 21 days | Frequency of food intake |
| Parent's anxiety and depression | baseline, day 21 | Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of \>8 points out of a possible 21 denotes considerable symptoms of anxiety or depression. |
| Fecal microbiome | baseline, day 21 | Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis |
| Fecal calprotectin | baseline, day 21 | Change on calprotectin in feces |
| Adverse events | 21 days | Frequency of adverse events reported on dairy report form after randomization and until day 21 |
Countries
Mexico, Spain
Outcome results
None listed