Clinical trial NCT05271747: Prospective Study to Determine the Factors Influencing Infant Colic
Official title: Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Colic
Keywords: Infant colic, probiotic
Lead sponsor: AB Biotics, SA
Sponsor class: INDUSTRY
First posted: 2022-03-09
Enrollment: 112
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Duration of crying and fussing
timeFrame: 21 days
measure: Percent of responders
timeFrame: 7, 14, 21 days
Secondary outcomes:
measure: Number of regurgitations
timeFrame: 21 days
measure: Bowel movements
timeFrame: 21 days
measure: Food intake
timeFrame: 21 days
measure: Parent's anxiety and depression
timeFrame: baseline, day 21
measure: Fecal microbiome
timeFrame: baseline, day 21
measure: Fecal calprotectin
timeFrame: baseline, day 21
measure: Adverse events
timeFrame: 21 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Hospital Medica Sur, room 108, tower 2
city: Cartagena
country: Spain
facility: University Hospital Santa Lucía
state: Murcia
city: Barcelona
country: Spain
facility: HM Hospitals
city: Madrid
country: Spain
facility: Hm Hospitals
Study officials:
References:
citation: 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.