Infant ColicDISICNCT07017244
Effect of a Dietary Supplement vs Low-dosage Product on Infant Gastrointestinal Discomfort and Colics
A study testing Verum and Active comparator in people with Infant Colic and Gut Microbiota, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 0 to 9 months
- Conditions the study is for
- Infant Colic, Gut Microbiota
- What is being tested?
- Verum and Active comparator
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jun 2025to 15 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
Gioacchino Calapai
Messina, 98125
Gioacchino Calapai, MD, 0902213646, gcalapai@unime.it
Carmen Mannucci, BSc, 0902212697, cmannucci@unime.it
About this study
Official title: 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
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.
Read the 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
- Being tested
- Verum, Active comparator
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VerumDietary supplement
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
Active comparatorDietary supplement
1st cycle - 30 days continuous use Cycle 2 - 30-day washout
| Study group | Role | What they receive |
|---|---|---|
| Verum | Experimental | 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 Receives: Dietary Supplement: Verum |
| Low-dosage product | Active comparator | 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 Receives: Dietary Supplement: Active comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: T0 (first visit) - T1 (after 7 days) - T2 (after 15 days) - T3 (after 30 days) - T4 (after 60 days)
Secondary outcomes (1)
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2025
- Study start15 Jun 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion15 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant ColicStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized and Double-Blind Controlled Vs Low-dosage product
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07017244
- Sponsor's protocol ID
- ENTEROBABY
- Acronym
- DISIC
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07017244
- Acronym / sponsor ID
- DISIC / ENTEROBABY
- Conditions
- Infant Colic, Gut Microbiota
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Policlinico "G. Martino"University, hospital or other
- Study start
- 15 Jun 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 15 Dec 2025 (estimated)
- First posted
- 12 Jun 2025 (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 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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Prospective Randomized and Double-Blind Controlled Vs Low-dosage product
| Arm | Type | Receives |
|---|---|---|
| Verum | Experimental | Dietary Supplement: VerumPartecipants 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 |
| Low-dosage product | Active comparator | Dietary Supplement: Active comparatorPartecipants 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 |
Who may qualify
- Ages
- 0 to 9 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (11 listed)
- 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
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 |
|---|---|---|
| Verum1st cycle - 30 days continuous use Cycle 2 - 30-day washout | Dietary supplement | Verum |
| Active comparator1st cycle - 30 days continuous use Cycle 2 - 30-day washout | Dietary supplement | Low-dosage product |
Primary outcome
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.
1 secondary outcome
Evaluation of relative abundance of the gut microbiota probiotic treatment species
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verum and Active comparator in people with Infant Colic and Gut Microbiota, run by Azienda Ospedaliera Universitaria Policlinico "G. Martino" 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 1 inclusion and 11 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: opening soon, as of the sponsor's last update on 12 Jun 2025. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). 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 12 Jun 2025.