Randomized Double-blind Monocentric Clinical Trial on the Effect of a Dietary Supplement vs Low-dosage Product on Reduction of Infant Gastrointestinal Discomfort and Colics
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Care Provider)
Masking Description
Different batch code assigned to products, same labeling
Eligibility Criteria
- Ages
- 0 Months to 9 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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
Intervention: Verum (Dietary Supplement)
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
Intervention: Active comparator (Dietary Supplement)
Outcomes
Primary Outcomes
Evaluation of infant gastrointestinal discomfort and colics by measuring the medium full-force daily crying
Time Frame: T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days)
The mean daily minutes of crying will be calculated as a sum of crying, fussing, and unsuitable crying using a parental diary.
Secondary Outcomes
- 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.)