Infantile ColicCSUB0214NCT07894445
The Effect of Probiotics in Infantile Colic
A study testing Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day in people with Infantile Colic, run by Federico II University at 1 site in Italy.
Trial summary
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II. The study evaluates whether daily oral supplementation with Limosilactobacillus reuteri DSM 17938 and BG-R46 reduces crying and fussing time more rapidly… Read more about this study
- Who is it for?
- Ages 3 to 12 weeks
- Conditions the study is for
- Infantile Colic
- What is being tested?
- Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 23 Sep 2026to Sep 2027
- 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 3 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age 3-12 weeks at screening;
- gestational age 37+0 to 42+0 weeks;
- birth weight appropriate or large for gestational age;
- parent/caregiver/legal guardian older than 18 years;
- exclusive or predominant breastfeeding (>50%);
- willingness to maintain feeding pattern and complete diaries and questionnaires;
- physician-confirmed Rome IV infantile colic, parental report of ≥3 hours of crying/fussing per day on ≥3 days in the prior week, and ≥3 hours in at least one 24-hour period documented in the run-in diary;
- written informed consent; mother available for scheduled visits; infant otherwise clinically healthy.
Who cannot join
- Severe gastroesophageal reflux (as defined in the protocol);
- failure to thrive;
- intrauterine growth restriction;
- hematochezia;
- significant diarrhea or fever ≥38 °C;
- congenital heart disease, immunodeficiency, asplenia, malignancy, cystic fibrosis or liver disease;
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- probiotic or systemic/oral antibiotic use in the 7 days before screening or anticipated use during the study;
- use of treatments for infantile colic; including proton pump inhibitors; in the 7 days before screening or during the study.
- Infant and mother must not participate concurrently in another interventional clinical study.
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, 1 recruiting
- Recruiting
Family pediatricians
Naples, 80100
Roberto Berni Canani, MD, PhD, +390817462680, berni@unina.it
About this study
Official title: Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Limosilactobacillus Reuteri on Crying and Fussing Time in Infants With Infantile Colic
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II. The study evaluates whether daily oral supplementation with Limosilactobacillus reuteri DSM 17938 and BG-R46 reduces crying and fussing time more rapidly than an indistinguishable placebo in otherwise healthy infants with Rome IV infantile colic.
Read the detailed description
Eligible participants will meet the clinical description for having infant colic. Participants will be assessed for eligibility at the screening visit and must meet all specified inclusion and exclusion criteria. Based on screening examinations, the individual Family Pediatrician (PLS) is solely responsible for determining clinical eligibility and making the final enrollment decision, which will be documented on the Participant Screening and Enrolment Log. The Scientific Coordinator will exclusively monitor aggregate screening logs and enrollment targets across all active sites, without direct involvement in the clinical selection. Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
- Conditions
- Infantile Colic
- Being tested
- Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day, Placebo: matching oil formulation without L. reuteri
- Keywords
- infants; probiotics
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/dayDietary supplement
5 oral drops once daily for 21 days.
Placebo: matching oil formulation without L. reuteriDietary supplement
5 oral drops once daily for 21 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day, 5 oral drops once daily for 21 days Receives: Dietary Supplement: Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day |
| Placebo | Placebo comparator | Placebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days. Receives: Dietary Supplement: Placebo: matching oil formulation without L. reuteri |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily total crying and fussing time at day 7
Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Measured: 7 days after initiation of intervention
Secondary outcomes (13)
Change in daily total crying and fussing time from baseline to day 7
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Measured: At Day 0 and at day 7 of intervention
Change in daily total crying and fussing time from baseline to every day during 21days of treatment
Total infant crying duration and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Measured: During 21 days of treatment
Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary)
Proportion of patients responders to the treatment, defined as the number of infants with ≥50% reduction in crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Measured: During the first 21 days of treatment
Sleeping time
Total infant sleep duration, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
Measured: During the first 21 days of treatment
PedsQL Family Impact Module
Changes in PedsQL Family Impact Module range 0-100 (with higher scores reflecting better functioning) from baseline to Days 7 and 21
Measured: During 21 days of treatment
Maternal Edinburgh Postnatal Depression Scale score
Changes in Maternal Edinburgh Postnatal Depression Scale score evaluation Total score range: 0 to 30 (higher score on the Edinburgh Postnatal Depression Scale (EPDS) indicates a greater severity of symptoms) from baseline to Days 7 and 21
Measured: During 21 days of treatment
Number of participants experiencing adverse events and serious adverse events.
Number of participants experiencing at least one adverse event (AE) or serious adverse event (SAE) during the study. Events will be recorded and characterized according to type, severity, seriousness, and relationship to the study intervention.
Measured: From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events
Body temperature
body temperature (°C)
Measured: At day 0, 21 and 28
Heart rate
heart rate (BPM)
Measured: At day 0, 21 and 28
Respiratory rate
Respiratory rate/minute
Measured: At day 0, 21 and 28
Blood pressure
blood pressure (mmHg)
Measured: At day 0, 21 and 28
Height
Height in cm
Measured: At day 0, 21 and 28
Weight
Weight in Kg
Measured: At day 0, 21 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study start23 Sep 2026
- Primary completionJul 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infantile ColicStudies of the same condition, open and under way.
- More trials run by Federico II UniversityThe sponsor's other registered studies.
- 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
- Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federico II University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roberto Berni Canani, MD, PhD, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07894445
- Sponsor's protocol ID
- 204/26
- Acronym
- CSUB0214
- Status last verified
- Oct 2026
- First submitted
- 24 Sep 2026
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Effect of Limosilactobacillus Reuteri on Crying and Fussing Time in Infants With Infantile Colic
- ClinicalTrials.gov ID
- NCT07894445
- Acronym / sponsor ID
- CSUB0214 / 204/26
- Conditions
- Infantile Colic
- Keywords
- infants; probiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Federico II UniversityUniversity, hospital or other
- Study start
- 23 Sep 2026 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 26 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.
Academic, independent, non-commercial, multicenter study sponsored by the Department of Translational Medical Sciences (DISMET), University of Naples Federico II. The study evaluates whether daily oral supplementation with Limosilactobacillus reuteri DSM 17938 and BG-R46 reduces crying and fussing time more rapidly than an indistinguishable placebo in otherwise healthy infants with Rome IV infantile colic.
Detailed description
Eligible participants will meet the clinical description for having infant colic. Participants will be assessed for eligibility at the screening visit and must meet all specified inclusion and exclusion criteria. Based on screening examinations, the individual Family Pediatrician (PLS) is solely responsible for determining clinical eligibility and making the final enrollment decision, which will be documented on the Participant Screening and Enrolment Log. The Scientific Coordinator will exclusively monitor aggregate screening logs and enrollment targets across all active sites, without direct involvement in the clinical selection. Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Fifty infants will be randomized 1:1 to probiotic or placebo. Each participant will complete a 7-day run-in, 21 days of treatment and 7 days of safety follow-up.
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Dietary Supplement: Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/dayProbiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day, 5 oral drops once daily for 21 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo: matching oil formulation without L. reuteriPlacebo: matching oil formulation without L. reuteri, 5 oral drops once daily for 21 days. |
Who may qualify
- Ages
- 3 to 12 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Age 3-12 weeks at screening;
- gestational age 37+0 to 42+0 weeks;
- birth weight appropriate or large for gestational age;
- parent/caregiver/legal guardian older than 18 years;
- exclusive or predominant breastfeeding (>50%);
Key exclusion criteria (9 listed)
- Severe gastroesophageal reflux (as defined in the protocol);
- failure to thrive;
- intrauterine growth restriction;
- hematochezia;
- significant diarrhea or fever ≥38 °C;
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 |
|---|---|---|
| Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day5 oral drops once daily for 21 days. | Dietary supplement | Probiotic |
| Placebo: matching oil formulation without L. reuteri5 oral drops once daily for 21 days. | Dietary supplement | Placebo |
Primary outcome
Daily total crying and fussing time at day 7
Time frame: 7 days after initiation of intervention
Total infant crying and fussing time, expressed as hours per 24-hour period, recorded daily by parents on baby's day diary
13 secondary outcomes
Change in daily total crying and fussing time from baseline to day 7
Time frame: At Day 0 and at day 7 of intervention
Change in daily total crying and fussing time from baseline to every day during 21days of treatment
Time frame: During 21 days of treatment
Proportion of responder patients assessed using a parent-completed daily sleep diary (Baby's Day Diary)
Time frame: During the first 21 days of treatment
Sleeping time
Time frame: During the first 21 days of treatment
PedsQL Family Impact Module
Time frame: During 21 days of treatment
Maternal Edinburgh Postnatal Depression Scale score
Time frame: During 21 days of treatment
Number of participants experiencing adverse events and serious adverse events.
Time frame: From initiation of the intervention (Day 1) through Day 28.Adverse events, serious adverse events
Body temperature
Time frame: At day 0, 21 and 28
Heart rate
Time frame: At day 0, 21 and 28
Respiratory rate
Time frame: At day 0, 21 and 28
Blood pressure
Time frame: At day 0, 21 and 28
Height
Time frame: At day 0, 21 and 28
Weight
Time frame: At day 0, 21 and 28
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 26 Oct 2026.
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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 Probiotic: L. reuteri DSM 17938 + BG-R46, total 2 × 10⁸ CFU/day in people with Infantile Colic, run by Federico II University 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 8 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 26 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?
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?
Contact Robeto Berni Canani, PhD, MD (+390817462680, berni@unina.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily total crying and fussing time at day 7 (time frame: 7 days after initiation of intervention). 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 26 Oct 2026.