Gut Microbiota ModulationNCT07882537
STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS.
A study testing Enterolactis Baby® drops in people with Gut Microbiota Modulation, run by Alfasigma S.p.A. at 1 site in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 0 to 48 hoursHealthy volunteers can take part
- Conditions the study is for
- Gut Microbiota Modulation
- What is being tested?
- Enterolactis Baby® drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2018to 9 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 48 hours
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 0-48 hours old;
- Infants of both sexes with a birth weight ≥1000g;
- Infants delivered by caesarean section;
- Written informed consent from the infants' parents/guardians.
Who cannot join
- Vaginal delivery;
- Extremely low birth weight (ELBW) (<1000g);
- Confirmed or suspected systemic infection;
- Known severe neurological disease;
- Known severe metabolic disease;
- Known genetic disease and chromosome disorders;
Show all 18Show fewer
- Known severe maternal primary or secondary immunodeficiency;
- Serious malformations (e.g. short bowel syndrome; intestinal occlusion; patency of the arterial duct may be included if asymptomatic and not requiring treatment);
- Known maternal food allergies;
- Maternal diabetes (including gestational diabetes);
- Recent or suspected history of alcohol or drug abuse in the mother;
- Any severe condition the investigator deems capable of interfering with treatment;
- Inadequate reliability or presence of conditions capable of resulting in non-conformity or non-compliance of the patient with the protocol.
- Administration of different probiotics other than the investigational product to the infant following start of the study.
- Use of probiotics by a breastfeeding mother following start of the study.
- Only for NBW:
- Systemic antibiotic treatment or prophylaxis from birth and throughout the duration of the study;
- Systemic antibiotic treatment or prophylaxis by a breastfeeding mother (of an NBW infant) over the 30 days prior to the trial and throughout the duration of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS. RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL.
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:
Read more
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:
- Receive Enterolactis Baby® or placebo twice daily for 28 days, starting when the infant was approximately 48 hours old.
- Provide stool samples so researchers can measure the probiotic and study changes in gut bacteria.
- Attend follow-up visits for up to 84 days after the start of the study.
- Have their bowel movements, growth, general health, and any unwanted medical events monitored during the study.
Read the detailed description
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.
- Conditions
- Gut Microbiota Modulation
- Being tested
- Enterolactis Baby® drops, Placebo
- Keywords
- L. casei DG, Lactobacillus paracasei CNCM I-1572, Enterolactis Baby, Probiotic supplementation, Gut microbiota, Preterm infants, Intestinal microbiota, Full-term infants, Neonatal microbiome, Stool microbiota, Infantile colic, metagenomics, metabolomics, L. paracasei DG
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enterolactis Baby® dropsDietary supplement
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.
PlaceboDietary supplement
Matching placebo administered as 9 drops twice daily for 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Enterolactis Baby® drops | Experimental | 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) Receives: Dietary Supplement: Enterolactis Baby® drops |
| Placebo | Placebo comparator | Participants received matching placebo, 9 drops twice daily for 28 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 28 days
Secondary outcomes (20)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Days 1, 10, 28, 56, and 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start2 Nov 2018
- Primary completion11 Apr 2020
- Study completion9 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut Microbiota ModulationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised, double-blind, monocentric, placebo-controlled clinical trial. Participants were stratified into three groups according to birth weight: normal birth weight (\>2,500 g), low birth weight (1,500-2,500 g), and very low birth weight (1,000-1,500 g). Within each birth-weight stratum, participants were randomized in a 1:1 ratio to receive Enterolactis Baby® or placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882537
- Sponsor's protocol ID
- PSC-DS ENNE 18
- Status last verified
- Oct 2026
- First submitted
- 23 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study documents do not specify a plan for sharing individual participant data
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF THE EFFECTS OF L. CASEI DG® (ENTEROLACTIS BABY) IN HEALTHY PRETERM AND FULL-TERM INFANTS. RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED CLINICAL TRIAL.
- ClinicalTrials.gov ID
- NCT07882537
- Acronym / sponsor ID
- PSC-DS ENNE 18
- Conditions
- Gut Microbiota Modulation
- Keywords
- L. casei DG, Lactobacillus paracasei CNCM I-1572, Enterolactis Baby, Probiotic supplementation, Gut microbiota, Preterm infants, Intestinal microbiota, Full-term infants
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Alfasigma S.p.A.Industry (pharma, biotech, devices)
- Collaborators
- 1Med
- Study start
- 2 Nov 2018 (actual)
- Primary completion
- 11 Apr 2020 (actual)
- Study completion
- 9 Jun 2020 (actual)
- First posted
- 20 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Receive Enterolactis Baby® or placebo twice daily for 28 days, starting when the infant was approximately 48 hours old.
- Provide stool samples so researchers can measure the probiotic and study changes in gut bacteria.
- Attend follow-up visits for up to 84 days after the start of the study.
- Have their bowel movements, growth, general health, and any unwanted medical events monitored during the study.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised, double-blind, monocentric, placebo-controlled clinical trial. Participants were stratified into three groups according to birth weight: normal birth weight (>2,500 g), low birth weight (1,500-2,500 g), and very low birth weight (1,000-1,500 g). Within each birth-weight stratum, participants were randomized in a 1:1 ratio to receive Enterolactis Baby® or placebo.
| Arm | Type | Receives |
|---|---|---|
| Enterolactis Baby® drops | Experimental | Dietary Supplement: Enterolactis Baby® dropsParticipants 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) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants received matching placebo, 9 drops twice daily for 28 days. |
Who may qualify
- Ages
- 0 to 48 hours
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 0-48 hours old;
- Infants of both sexes with a birth weight ≥1000g;
- Infants delivered by caesarean section;
- Written informed consent from the infants' parents/guardians.
Key exclusion criteria (18 listed)
- Vaginal delivery;
- Extremely low birth weight (ELBW) (<1000g);
- Confirmed or suspected systemic infection;
- Known severe neurological disease;
- Known severe metabolic disease;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enterolactis Baby® dropsEnterolactis 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. | Dietary supplement | Enterolactis Baby® drops |
| PlaceboMatching placebo administered as 9 drops twice daily for 28 days. | Dietary supplement | Placebo |
Primary outcome
Composition of faecal intestinal microbiota in terms of concentration of L. casei DG®
Time frame: 28 days
Bacterial genome count for L. casei DG® at 28th day of treatment using Real Time PCR
20 secondary outcomes
Indicators of dysbiosis of the intestinal microbiota (α-diversity and β-diversity) at 28, 56 and 84 days
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;
Time frame: Days 56 and 84 after the start of study product administration
Number of Faecal Evacuations
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Amount Category on the Amsterdam Infant Stool Scale
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Colour Category on the Amsterdam Infant Stool Scale
Time frame: Days 1, 10, 28, 56, and 84
Number of Faecal Evacuations by Consistency Category on the Amsterdam Infant Stool Scale
Time frame: Days 1, 10, 28, 56, and 84
Change in the Overall Stool Volatile Metabolomic Profil
Time frame: Days 28, 56, and 84 after the start of study product administration
Presence of Infantile Colic Based on Rome IV Criteria
Time frame: Study Days 10, 28, 56, and 84
Evaluation of adverse events
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
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Soap Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Stercobilinogen Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Meat and Vegetable Fibre Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Mucus Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Amide Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Faecal pH Category
Time frame: Days 1, 10, 28, 56, and 84
Number of Participants by Neutral Fat Status in Faeces
Time frame: Days 1, 10, 28, 56, and 84
Mean Body Weight
Time frame: Days 1, 10, 28, 56, and 84
Mean Head Circumference
Time frame: Days 1, 10, 28, 56, and 84
Mean Body Length
Time frame: Days 1, 10, 28, 56, and 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: No. The study documents do not specify a plan for sharing individual participant data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enterolactis Baby® drops in people with Gut Microbiota Modulation, run by Alfasigma S.p.A. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composition of faecal intestinal microbiota in terms of concentration of L. casei DG® (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.