An interventional study of AB-Kolicare and Reuteri gotas in Infant Colic, sponsored by AB Biotics, SA. Completed at 4 sites in 2 countries. Open to participants aged 2 Weeks to 12 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by AB Biotics, SA (part of Kaneka Corporation) · Not applicable, Interventional, and Other
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.
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's enrollment of 112 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →AB Biotics, SA is the lead sponsor of 26 studies on the registry; 4 are open to participants now.
First submitted after AB Biotics, SA became part of Kaneka Corporation.
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Exclusion Criteria:
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
Dietary Supplement: AB-Kolicare
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
Dietary Supplement: Reuteri gotas
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
Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
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.
Time frame: 21 days
Percent of responders
Percent of subjects whose change in crying time is equal or larger than 50% from baseline
Time frame: 7, 14, 21 days
Number of regurgitations
Change in daily number of regurgitations
Time frame: 21 days
Bowel movements
Change in daily number of bowel movements
Time frame: 21 days
Food intake
Frequency of food intake
Time frame: 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.
Time frame: baseline, day 21
Fecal microbiome
Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis
Time frame: baseline, day 21
Fecal calprotectin
Change on calprotectin in feces
Time frame: baseline, day 21
Adverse events
Frequency of adverse events reported on dairy report form after randomization and until day 21
Time frame: 21 days
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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