Prospective Study to Determine the Factors Influencing Infant Colic

Infant Colic Clinical Trial

Official title:

Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05271747
• Other study ID #: Pro-care 2
• Status: Completed
• Phase: N/A
• Start date: March 1, 2019
• Est. completion date: December 30, 2023

Study information

• Verified date: March 2024
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: December 30, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Weeks to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Colic
• Infant Colic

Intervention

Dietary Supplement:
• AB-Kolicare
Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 for 21 days, 5 drops/day preferably during the first intake of milk
• Reuteri gotas
Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.

Locations

Country	Name	City	State
Mexico	Hospital Medica Sur, room 108, tower 2	Mexico City
Spain	HM Hospitals	Barcelona
Spain	University Hospital Santa Lucía	Cartagena	Murcia
Spain	Hm Hospitals	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Countries where clinical trial is conducted

Mexico,  Spain, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Percent of responders	Percent of subjects whose change in crying time is equal or larger than 50% from baseline	7, 14, 21 days
Secondary	Number of regurgitations	Change in daily number of regurgitations	21 days
Secondary	Bowel movements	Change in daily number of bowel movements	21 days
Secondary	Food intake	Frequency of food intake	21 days
Secondary	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
Secondary	Fecal microbiome	Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis	baseline, day 21
Secondary	Fecal calprotectin	Change on calprotectin in feces	baseline, day 21
Secondary	Adverse events	Frequency of adverse events reported on dairy report form after randomization and until day 21	21 days