Status:
COMPLETED
Prospective Study to Determine the Factors Influencing Infant Colic
Lead Sponsor:
AB Biotics, SA
Conditions:
Infant Colic
Eligibility:
All Genders
2-12 years
Phase:
NA
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 ...
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 differ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2023
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT05271747
Start Date
March 1 2019
End Date
December 30 2023
Last Update
March 28 2024
Active Locations (4)
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1
Hospital Medica Sur, room 108, tower 2
Mexico City, Mexico, 14050
2
University Hospital Santa Lucía
Cartagena, Murcia, Spain, 30202
3
HM Hospitals
Barcelona, Spain
4
Hm Hospitals
Madrid, Spain