An interventional study of Verum and Active comparator in Infant Colic and Gut Microbiota, sponsored by Azienda Ospedaliera Universitaria Policlinico "G. Martino". Not yet recruiting at 1 site in Italy. Open to participants aged 0 Months to 9 Months. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Azienda Ospedaliera Universitaria Policlinico "G. Martino" · Not applicable, Interventional, and Treatment
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.
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
127 studies on the registry are indexed under Colic; 18 are open to participants now.
This study's planned enrollment of 150 is above the median of 76 across 110 interventional studies indexed under Colic.
Browse Colic studies →Azienda Ospedaliera Universitaria Policlinico "G. Martino" is the lead sponsor of 16 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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
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
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
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.
Time frame: T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days)
Evaluation of relative abundance of the gut microbiota probiotic treatment species
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.
Time frame: 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.
This study is not yet recruiting, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Universitaria Policlinico "G. Martino"