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

NCT ID: NCT07017244

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-15
• Study Completion Date: 2025-12-15

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.

Detailed Description

Infant colic, characterized by excessive crying/fussing for no apparent cause, is common and distressing to families.

The exact causes of infant colic are heterogeneous and not fully understood in detail, but some likely hypotheses point on factors such as gut dysmotility and food intolerance. Growing evidence suggests that the gut microbiota could be also involved in colics: a higher amount of Coliforms and a lower amount of Lactobacilli have been found in colicky infants compared to non-colicky subjects, and probiotic supplementation with Lactobacillus reuteri has been shown to be effective in treating the condition in some clinical trials of breastfed infants.

In the present study, the investigator performs a randomized controlled clinical trial aimed to verify whether a food supplement is effective in treating infantile colic of infants and colonization ability of the gut microbiota by measuring faecal relative abundance of the gut microbiota probiotic treatment species.

The product is a food supplement based on freeze-dried probiotics (Lactobacillus reuteri DSM 25175 and Lactobacillus acidophilus DSM 24936) and chamomile oleolite to promote the balance of the intestinal bacterial flora, on gastrointestinal discomfort in children aging 0-9 months.

Treatment consists of taking the product or the low-dosage product 7 drops x 2/die for a 30-days. A follow-up was made after 30 days wash out.

Infant colics are diagnosed with FLACC (Face, Legs, Activity, Cry, Consolability

• preverbal patient pain scale) and G4 Infant Colic Rome IV criteria, while relative abundance of the gut microbiota probiotic treatment species (L. reuteri and L. acidophilus) will be evaluated using quantitative PCR (Polymerase Chain Reaction), in order to identify the colonization ability of the study treatment (Fecal sample).

Conditions

Infant Colic; Gut Microbiota

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Verum

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

Group Type: EXPERIMENTAL

Verum

Intervention Type: DIETARY_SUPPLEMENT

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

Low-dosage product

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

Group Type: ACTIVE_COMPARATOR

Active comparator

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Verum

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

Intervention Type: DIETARY_SUPPLEMENT

Active comparator

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 9 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Universitaria Policlinico "G. Martino"

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Gioacchino Calapai

Messina, , Italy

Countries

Italy

Facility Contacts

Gioacchino Calapai, MD

Role: primary

gcalapai@unime.it

0902213646

Carmen Mannucci, BSc

Role: backup

cmannucci@unime.it

0902212697

Other Identifiers

ENTEROBABY

Identifier Type: -

Identifier Source: org_study_id