Prospective Study to Determine the Factors Influencing Infant Colic

NCT05271747 | Completed

• 1 other identifier: Pro-care 2
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 4

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.

Conditions

Infant Colic

Keywords

Infant colic, probiotic

Outcome Measures

Primary Outcomes (2)

• 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

• Percent of responders

  Percent of subjects whose change in crying time is equal or larger than 50% from baseline

  7, 14, 21 days

Secondary Outcomes (7)

• Number of regurgitations

  21 days

• Bowel movements

  21 days

• Food intake

  21 days

• Parent's anxiety and depression

  baseline, day 21

• Fecal microbiome

  baseline, day 21

Study Arms (2)

AB- Kolicare

ACTIVE COMPARATOR

Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority

Dietary Supplement: AB-Kolicare

Reuteri gotas

ACTIVE COMPARATOR

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

Dietary Supplement: Reuteri gotas

Interventions

AB-Kolicare DIETARY_SUPPLEMENT

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

AB- Kolicare

Reuteri gotas DIETARY_SUPPLEMENT

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

Reuteri gotas

Eligibility Criteria

• Age: 2 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants that are fed with solid food.
• Infants whose parents can not appropriately follow the requirements of 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.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (4)

Hospital Medica Sur, room 108, tower 2

Mexico City, 14050, Mexico

Location

University Hospital Santa Lucía

Cartagena, Murcia, 30202, Spain

Location

HM Hospitals

Barcelona, Spain

Location

Hm Hospitals

Madrid, Spain

Location

Related Publications (2)

• 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.

  PMID: 27147121 BACKGROUND

• Moreno-Villares JM, Andrade-Platas D, Soria-Lopez M, Colome-Rivero G, Catalan Lamban A, Martinez-Figueroa MG, Espadaler-Mazo J, Valverde-Molina J. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. Eur J Pediatr. 2024 Dec;183(12):5371-5381. doi: 10.1007/s00431-024-05806-x. Epub 2024 Oct 11.

  PMID: 39390276 DERIVED

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 9, 2022
• Study Start: March 1, 2019
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2023
• Last Updated: February 24, 2026

Record last verified: 2024-03

Locations

ME (1); ES (3)