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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AB- Kolicare | Active Comparator | Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority |
|
| Reuteri gotas | Active Comparator | Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AB-Kolicare | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of crying and fussing | 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. | 21 days |
| Percent of responders | Percent of subjects whose change in crying time is equal or larger than 50% from baseline | 7, 14, 21 days |
| Measure | Description | Time Frame |
|---|---|---|
| Number of regurgitations | Change in daily number of regurgitations | 21 days |
| Bowel movements | Change in daily number of bowel movements |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Medica Sur, room 108, tower 2 | Mexico City | 14050 | Mexico | |||
| University Hospital Santa LucÃa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27147121 | Background | Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available. | |
| 39390276 | Derived | Moreno-Villares JM, Andrade-Platas D, Soria-Lopez M, Colome-Rivero G, Catalan Lamban A, Martinez-Figueroa MG, Espadaler-Mazo J, Valverde-Molina J. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. Eur J Pediatr. 2024 Dec;183(12):5371-5381. doi: 10.1007/s00431-024-05806-x. Epub 2024 Oct 11. |
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| ID | Term |
|---|---|
| D003085 | Colic |
| ID | Term |
|---|---|
| D007232 | Infant, Newborn, Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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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
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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.
| Reuteri gotas | Dietary Supplement | Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal. |
|
| 21 days |
| Food intake | Frequency of food intake | 21 days |
| Parent's anxiety and depression | 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. | baseline, day 21 |
| Fecal microbiome | Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis | baseline, day 21 |
| Fecal calprotectin | Change on calprotectin in feces | baseline, day 21 |
| Adverse events | Frequency of adverse events reported on dairy report form after randomization and until day 21 | 21 days |
| Cartagena |
| Murcia |
| 30202 |
| Spain |
| HM Hospitals | Barcelona | Spain |
| Hm Hospitals | Madrid | Spain |