Prospective Study to Determine the Factors Influencing Infant Colic

Sponsor

AB Biotics, SA (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05271747

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infant Colic	Dietary Supplement: Lactoflora colicare Dietary Supplement: Reuteri gotas	N/A

Detailed Description

Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different comercialized 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, multicentric, single-blind trial in 100 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. Pentosaceous (branch one) or L. Reuteri (branch two) for 21 daysRandomized, multicentric, single-blind trial in 100 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. Pentosaceous (branch one) or L. Reuteri (branch two) for 21 days

Masking:

Single (Investigator)

Masking Description:

Both probiotic products will be provided in their commercial form. Both products will be individually placed inside opaque bags so that the investigator can not recognize the external case.

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Mar 1, 2019

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Lactoflora colicare Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority	Dietary Supplement: Lactoflora colicare 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
Active Comparator: Reuteri gotas Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain trygliceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority	Dietary Supplement: Reuteri gotas Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.

Arm

Intervention/Treatment

Active Comparator: Lactoflora colicare

Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8830 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Dietary Supplement: Lactoflora colicare

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

Active Comparator: Reuteri gotas

Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain trygliceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Dietary Supplement: Reuteri gotas

Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.

Outcome Measures

Primary Outcome Measures

Duration of crying and fussing [21 days]
Change on daily crying and fussing minutes measured through Barr validated crying and fussing scale

Secondary Outcome Measures

Number of regurgitations [21 days]
Change in daily number of regurgitations
Bowel movements [21 days]
Change in daily number of bowel movements
Food intake [21 days]
Frequency of food intake
Parent's anxiety and depression [baseline, day 21]
Change in parent's anxiety and depression score measured through HADS scale
Fecal microbiome [baseline, day 21]
Changes on fecal microbiome evaluated by 16S analysis
Fecal calprotectin [baseline, day 21]
Change on calprotectin in feces
Adverse events [21 days]
Frequency of adverse events reported on dairy report form after randomization and until day 21

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Weeks to 12 Weeks

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 appropiately 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.
Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative 8PEG, lactulose, magnesia), lactase or simeticone.
Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospital Santa Lucía	Cartagena	Murcia	Spain	30202

Sponsors and Collaborators

AB Biotics, SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

AB Biotics, SA

ClinicalTrials.gov Identifier:

NCT05271747

Other Study ID Numbers:

Pro-care 2

First Posted:

Mar 9, 2022

Last Update Posted:

Mar 9, 2022

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by AB Biotics, SA

Infant colic, probiotic

Additional relevant MeSH terms:

Colic

Study Results

No Results Posted as of Mar 9, 2022