Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics

NCT07017244 | Not Yet Recruiting

• 1 other identifier: ENTEROBABY
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to verify whether a food supplement is effective in treating infantile colic of infants aged between 21 days and 9 months and the colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species. The main outcomes are: - the mean number of crying episodes and the sleep duration - Relative abundance of the gut microbiota probiotic treatment species.

Conditions

Infant Colic; Gut Microbiota

Outcome Measures

Primary Outcomes (1)

• Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying

  The mean daily minutes of crying will be calculated as a sum of crying, fussing, and unsuitable crying using a parental diary.

  T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days)

Secondary Outcomes (1)

• Evaluation of relative abundance of the gut microbiota probiotic treatment species

  Faecal samples will be collected from each subject before starting supplementation, at the end of the study period T3 (30 days) and at T4 (after 30 days wash out) and will be analyzed.

Study Arms (2)

Verum

EXPERIMENTAL

Partecipants received Enterobaby, a food supplement based on a mixture of Lactobacillus acidophilus DSM 25175, Lactobacillus reuteri DSM 24936, Matricaria chamomilla L. oleolite, extra-virgin olive oil in oral suspension

Dietary Supplement: Verum

Low-dosage product

ACTIVE COMPARATOR

Partecipants received a food supplement based on a mixture of maltodextrine, Magnesium stearate and Sun flower oil and less than 0,1% of Lactobacillus acidophilus DSM 25175 and Lactobacillus reuteri DSM 24936, 1% of Matricaria chamomilla L. oleolite and extra-virgin olive oil in oral suspension

Dietary Supplement: Active comparator

Interventions

Verum DIETARY_SUPPLEMENT

1st cycle - 30 days continuous use Cycle 2 - 30-day washout

Verum

Active comparator DIETARY_SUPPLEMENT

1st cycle - 30 days continuous use Cycle 2 - 30-day washout

Low-dosage product

Eligibility Criteria

• Age: 0 Months - 9 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children Age: 0-9 months Infant colics diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability - preverbal patient pain scale) and G4 Infant Colic Rome IV criteria

You may not qualify if:

• infants suffering from acute or chronic diseases, such as chronic lung disease; diarrhea underlying specific diseases or developmental disorders confirmed by a pediatrician
• infants participating in other clinical studies
• age ≥ 9 months
• neurological diseases
• suspected or confirmed food allergy to the ingredients of the products under study
• gastroesophageal reflux disease
• use of antibiotics 1-2 weeks before enrolment
• use of gastric acidity inhibitors at any time before enrolment
• fever and/or infectious diseases at any time before enrolment
• current systemic infections
• history of congenital infections

Sponsors & Collaborators

• Azienda Ospedaliera Universitaria Policlinico "G. Martino": lead

Study Sites (1)

Gioacchino Calapai

Messina, 98125, Italy

Location

MeSH Terms

Conditions

Colic

Interventions

calcium D-pantothenate, L-cysteine drug combination

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Different batch code assigned to products, same labeling
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized and Double-Blind Controlled Vs Low-dosage product

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: June 12, 2025
• Study Start: June 15, 2025
• Primary Completion: October 15, 2025
• Study Completion: December 15, 2025
• Last Updated: June 12, 2025

Record last verified: 2025-05

Locations

IT (1)