An interventional study of Enterolactis Baby® drops and Placebo in Gut Microbiota Modulation, sponsored by Alfasigma S.p.A.. Completed at 1 site in Italy. Open to participants aged 0 Hours to 48 Hours, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Alfasigma S.p.A. · Not applicable, Interventional, and Prevention
The goal of this clinical trial was to learn whether giving Enterolactis Baby®, a probiotic food supplement containing Lactobacillus casei DG® (under the new taxonomical denomination: Lacticaseibacillus paracasei DG, CNCM I-1572), to healthy preterm and full-term infants from approximately 48 hours after birth for 28 days affected the bacteria naturally living in the infants' gut.
The main question it aims to answer is:
Does taking Enterolactis Baby® for 28 days change the amount of L. paracasei DG found in the infants' stool?
Researchers will compare infants receiving Enterolactis Baby® with infants receiving a placebo to see whether the probiotic affects gut bacteria, bowel movements, colic, growth, and general health.
Participants will:
This is a randomized, double-blind, single-center, placebo-controlled clinical trial evaluating the effects of early supplementation with Enterolactis Baby®, a food supplement containing Lacticaseibacillus paracasei DG (CNCM I-1572), on the gut microbiota of healthy preterm and full-term infants. The study takes place at the Neonatology Unit of Policlinico Casilino in Rome, Italy.
The planned sample size is 60 infants stratified according to birth weight into normal birth weight, low birth weight, and very low birth weight groups. Overall, the study includes 61 enrolled infants, of whom 60 are randomized in a 1:1 ratio to receive Enterolactis Baby® or placebo.
The study product is first administered when the infant is approximately 48 hours old. Infants receive 9 drops twice daily for 28 days. The active treatment provides approximately 2 billion colony-forming units of L. paracasei DG per day. The placebo is designed to be indistinguishable from the active product but does not contain L. paracasei DG.
Stool samples are collected at baseline and at approximately days 10, 28, 56, and 84. Samples intended for molecular analysis are stored at -20°C and transported on dry ice to the Laboratory of Parasitology/Human Microbiome at Bambino Gesù Children's Hospital. Real-time polymerase chain reaction is used to quantify L. paracasei DG in stool. Metagenomic and metabolomic analyses are also performed to characterize changes in the composition and functional activity of the gut microbiota.
Parents or legal guardians record information about stool frequency and consistency in a study diary. Clinical assessments include infant growth, episodes of infantile colic according to Rome IV criteria, treatment compliance, tolerability, and adverse events.
Five study visits are scheduled: baseline at 0 to 48 hours of age, day 10 ±2 days, day 28 ±3 days, day 56 ±3 days, and day 84 ±3 days. The treatment period lasts 28 days and is followed by an 8-week follow-up period. The protocol-planned overall study duration, including recruitment, is approximately 36 weeks.
154 studies on the registry are indexed under Colic; 19 are open to participants now.
This study's enrollment of 61 is below the median of 80 across 127 interventional studies indexed under Colic.
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Exclusion Criteria:
Only for NBW:
Participants received Enterolactis Baby® drops, 9 drops twice daily for 28 days, corresponding to a total daily dose of 2 billion CFU of L. casei DG® (Lactobacillus paracasei CNCM I-1572)
Dietary Supplement: Enterolactis Baby® drops
Participants received matching placebo, 9 drops twice daily for 28 days.
Dietary Supplement: Placebo
Enterolactis Baby® drops containing L. casei DG® (Lactobacillus paracasei CNCM I-1572). Participants received 9 drops twice daily for 28 days, corresponding to 2 billion CFU per day.
Matching placebo administered as 9 drops twice daily for 28 days.
Composition of faecal intestinal microbiota in terms of concentration of L. casei DG®
Bacterial genome count for L. casei DG® at 28th day of treatment using Real Time PCR
Time frame: 28 days
Indicators of dysbiosis of the intestinal microbiota (α-diversity and β-diversity) at 28, 56 and 84 days
Alpha diversity was assessed using the Shannon index to evaluate microbial richness and diversity within stool samples. Beta diversity was assessed using Unweighted UniFrac distance matrices and principal coordinate analysis to evaluate differences in overall gut microbiota composition. Stool samples were analyzed using 16S rRNA-targeted metagenomic sequencing. Comparisons were performed between the Enterolactis Baby® and placebo groups and across study visits.
Time frame: Days 28, 56, and 84 after the start of study product administration
Bacterial genome count for L. casei DG® at 56 and 84 days;
The concentration of L. casei DG® (Lactobacillus paracasei CNCM I-1572) in stool samples was measured using a strain-specific real-time polymerase chain reaction (PCR) method. Results were expressed as colony-forming units per milliliter (CFU/mL) and compared between the Enterolactis Baby® and placebo groups during the follow-up period.
Time frame: Days 56 and 84 after the start of study product administration
Number of Faecal Evacuations
The total number of faecal evacuations recorded during the 24-hour period before each scheduled study visit was assessed by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Amount Category on the Amsterdam Infant Stool Scale
The amount of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Amount was classified using four categories ranging from 1 to 4. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. Higher categories do not necessarily indicate a better or worse outcome.
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Colour Category on the Amsterdam Infant Stool Scale
The colour of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Colour was classified using six categories ranging from I to VI. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. The categories are descriptive, and higher categories do not indicate a better or worse outcome.
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Consistency Category on the Amsterdam Infant Stool Scale
The consistency of each faecal evacuation recorded during the 24-hour period before each scheduled study visit was classified using the Amsterdam Infant Stool Scale. Consistency was classified using four principal categories ranging from A to D, with intermediate categories recorded where applicable. Results were summarized as the number of faecal evacuations in each category by treatment group and assessment time point. The categories are descriptive, and higher categories do not necessarily indicate a better or worse outcome.
Time frame: Days 1, 10, 28, 56, and 84
Change in the Overall Stool Volatile Metabolomic Profil
The overall stool volatile metabolomic profile was assessed by gas chromatography-mass spectrometry with solid-phase microextraction. Detected volatile metabolites were evaluated collectively using multivariate analyses to assess differences in the overall metabolic profile between the Enterolactis Baby and placebo groups across assessment time points.
Time frame: Days 28, 56, and 84 after the start of study product administration
Presence of Infantile Colic Based on Rome IV Criteria
The presence of infantile colic was assessed according to the Rome IV diagnostic criteria. The number and percentage of infants meeting the criteria for infantile colic were evaluated and compared between the Enterolactis Baby® and placebo groups.
Time frame: Study Days 10, 28, 56, and 84
Evaluation of adverse events
Adverse events were monitored throughout the study. The number and percentage of infants experiencing at least one adverse event were assessed by treatment group. Adverse events were evaluated with respect to seriousness, severity, outcome, and relationship to the study product.
Time frame: From Day 1 through Day 84, with assessments on Days 1, 10, 28, 56, and 84
Number of Participants by Fatty Acid Status in Faeces
Stool samples underwent physicochemical examination to assess fatty acid status. Results were summarized by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Soap Status in Faeces
Stool samples underwent physicochemical examination to classify soaps as present, absent, not evaluated, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Stercobilinogen Status in Faeces
Stool samples underwent physicochemical examination to assess stercobilinogen status at each scheduled assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Meat and Vegetable Fibre Status in Faeces
Stool samples underwent physicochemical examination to classify meat and vegetable fibres as present, absent, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Mucus Status in Faeces
Stool samples underwent physicochemical examination to classify mucus as present, absent, not evaluated, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Amide Status in Faeces
Stool samples underwent physicochemical examination to assess amide status at each scheduled assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Faecal pH Category
Stool samples underwent physicochemical examination to classify faecal pH as acidic, neutral, basic, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point. The categories are descriptive, and their order does not indicate a better or worse outcome.
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Neutral Fat Status in Faeces
Stool samples underwent physicochemical examination to classify neutral fat as present, absent, or missing. Results were summarized as the number of participants in each category by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Mean Body Weight
Body weight was measured in grams at each scheduled study visit. Results were summarized by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Mean Head Circumference
Head circumference was measured in centimetres at each scheduled study visit. Results were summarized by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Mean Body Length
Body length was measured in centimetres at each scheduled study visit. Results were summarized by treatment group and assessment time point.
Time frame: Days 1, 10, 28, 56, and 84
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — The study documents do not specify a plan for sharing individual participant data
Ran from Nov 2018 to primary completion in Apr 2020, 17 months.
Of 47 interventional studies with no phase under Colic, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 17 months is close to that.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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