Trials / Completed
CompletedNCT05271747
Prospective Study to Determine the Factors Influencing Infant Colic
Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- AB Biotics, SA · Industry
- Sex
- All
- Age
- 2 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | AB-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_SUPPLEMENT | Reuteri gotas | Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal. |
Timeline
- Start date
- 2019-03-01
- Primary completion
- 2023-12-30
- Completion
- 2023-12-30
- First posted
- 2022-03-09
- Last updated
- 2026-02-24
Locations
4 sites across 2 countries: Mexico, Spain
Source: ClinicalTrials.gov record NCT05271747. Inclusion in this directory is not an endorsement.