Colic, InfantileNCT05512234
Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying Time in Infants With Colic
A study testing L. reuteri in people with Colic, Infantile, run by BioGaia AB at 3 sites in 3 countries.
Trial summary
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time. Read more about this study
- Who is it for?
- Ages 3 to 12 weeks
- Conditions the study is for
- Colic, Infantile
- What is being tested?
- L. reuteri
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 102 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 13 Jul 2022to 10 Sep 2025
- 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 3 to 12 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 3-12 weeks at screening.
- Gestational age 37+0 weeks - 42+0 weeks at birth.
- Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
- Parents/caregivers/legal guardians are >18 years.
- Exclusively or predominantly breastfed infants (> 50 % breast fed).
- Willing to maintain current feeding patterns (not change formula/not change ratio of formula:breast milk etc.).
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- Readiness and the opportunity for parents/caregivers/legal guardians to fill out a study diary, questionnaires.
- Infantile colic diagnosed according to Rome IV criteria (face-to-face consult with a physician, parents/caregivers/legal guardians must report that their infant has cried or fussed for 3 or more hours per day, during 3 or more days in the preceding week). At Visit 2, this will be confirmed by Baby's Day Diary®, at least one 24-hour period should show 3 or more hours of crying/fussing time.
- Parents/caregivers/legal guardians with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- Parents/caregivers/legal guardians willing and able to give informed consent for their and their infant's participation in the study.
- The mother of the infant must be willing to attend Visit 2 (Day 0), Visit 4 (Day 8), and Visit 6 (Day 22).
- Infant is considered healthy, in the opinion of the investigator following physical exam.
Who cannot join
- Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
- Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/legal guardians.
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
- Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to medications, therapies, or products with the aim to relieve infantile colic including proton pump inhibitors in the 7 days prior to Screening Visit (V1) and throughout the study period.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Mexico1 site
Innovación y Desarrollo en Ciencias de la Salud SRL de CV
Mexico City, 14090
About this study
Official title: A Double-blind, Mylti-center, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Read the detailed description
Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.
Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.
- Conditions
- Colic, Infantile
- Being tested
- L. reuteri, Placebo
- Keywords
- Colic, L. reuteri
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L. reuteriDietary supplement
Dietary supplementation with drops containing L. reuteri once daily for 21 consecutive days
PlaceboDietary supplement
Dietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| L. reuteri | Experimental | 5 drops administered once daily for 21 days Receives: Dietary Supplement: L. reuteri |
| Placebo | Placebo comparator | 5 drops administered once daily for 21 days Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Crying and fussing time
Change in daily crying and fussing time measured by Baby Day Diary
Measured: From baseline to Day 7
Secondary outcomes (6)
Crying and fussing time
Change in mean daily crying and fussing time measured by Baby Day Diary
Measured: From baseline to Day 3, Day 5, Day 14, Day 21
Crying time
Change in mean daily crying time measured by Baby Day Diary
Measured: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Number of responders
Proportion of responders defined as reduction of daily average crying time with 50 % compared to baseline
Measured: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Family quality of life (family QoL)
Change in family QoL measured by the PedsQL Family Impact Module (Acute) - Total Score
Measured: From baseline to Day 7 and Day 21
Sleeping time
Change in mean sleeping time measured by Baby Day Diary
Measured: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Maternal depression
Change in maternal depression measured by the Edinburgh Postnatal Depression Scale Total Score
Measured: From baseline to Day 7 and Day 21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2022
- Study start13 Jul 2022
- Primary completion10 Sep 2025
- Study completion10 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, CTC Clinical Trial Consultants AB
- Responsible party
- Sponsor
- Investigators
- Jenny Palming, PhD, Study director, BioGaia AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05512234
- Sponsor's protocol ID
- CSUB0197
- Status last verified
- Oct 2026
- First submitted
- 22 Aug 2022
- Last updated
- 15 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 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Mylti-center, Randomised, Placebo-controlled, Parallel-group Study Evaluating the Effect of Probiotic Limosilactobacillus Reuteri (L. Reuteri) on Crying and Fussing Time in Infants With Colic
- ClinicalTrials.gov ID
- NCT05512234
- Acronym / sponsor ID
- CSUB0197
- Conditions
- Colic, Infantile
- Keywords
- Colic, L. reuteri
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, CTC Clinical Trial Consultants AB
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 10 Sep 2025 (actual)
- Study completion
- 10 Sep 2025 (actual)
- First posted
- 23 Aug 2022 (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.
This is a double-blind, multi-center, randomized, placebo-controlled, parallel-group study in infants with colic with the primary objective to evaluate crying time.
Detailed description
Prevalence of infantile colic varies according to the definition used but estimates range between 5 % and 26 % of the infant population. To differentiate colic from other, more serious conditions it should be characterized by several clinical features. Infant colic is often accompanied by flushing the face, frown, tensing of the abdomen, clenching of the fists, and drawing up the leg, frequent, prolonged, and intense crying or fussiness in a healthy infant. Even though infant colic is benign and usually self-limiting condition it is a source of major distress for the infant, parents, family, and health care givers.
Despite infant colic occurs frequently, little agreement has been reached on the definition, pathogenesis, or the optimal management strategy for infant colic. Recent systematic reviews and meta-analyses showed that probiotic L. reuteri DSM 17938 supplementation significantly lowered the number of hours of crying and fussing daily. A significant peak effect was seen at 3 weeks in most studies. Interestingly, babies with infant colic were found to have increased evidence of gut inflammation, as evidenced by high levels of the antimicrobial peptide fecal calprotectin; also, the levels of fecal calprotectin declined significantly as the condition resolved.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| L. reuteri | Experimental | Dietary Supplement: L. reuteri5 drops administered once daily for 21 days |
| Placebo | Placebo comparator | Dietary Supplement: Placebo5 drops administered 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 (12 listed)
- Aged between 3-12 weeks at screening.
- Gestational age 37+0 weeks - 42+0 weeks at birth.
- Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
- Parents/caregivers/legal guardians are >18 years.
- Exclusively or predominantly breastfed infants (> 50 % breast fed).
Key exclusion criteria (6 listed)
- Infants with severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk > 8 times daily, projectile, bilious or bloody emesis).
- Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container > 12x in breastfed and >5 in partially breastfed infants daily), or fever (38.0 degrees), as reported by parents/caregivers/legal guardians.
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, and those with liver disease.
- Infants with reported exposure to probiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
- Infants with reported exposure to oral and/or systemic antibiotics in the 7 days prior to Screening Visit (V1) and throughout the study period.
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 |
|---|---|---|
| L. reuteriDietary supplementation with drops containing L. reuteri once daily for 21 consecutive days | Dietary supplement | L. reuteri |
| PlaceboDietary supplementation with placebo drops identical to those containing L. reuteri once daily for 21 consecutive days | Dietary supplement | Placebo |
Primary outcome
Crying and fussing time
Time frame: From baseline to Day 7
Change in daily crying and fussing time measured by Baby Day Diary
6 secondary outcomes
Crying and fussing time
Time frame: From baseline to Day 3, Day 5, Day 14, Day 21
Crying time
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Number of responders
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Family quality of life (family QoL)
Time frame: From baseline to Day 7 and Day 21
Sleeping time
Time frame: From baseline to Day 3, Day 5, Day 7, Day 14, Day 21
Maternal depression
Time frame: From baseline to Day 7 and Day 21
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 15 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. This study is not recruiting at the moment.
Jenny Palming, PhD study director
BioGaia AB
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L. reuteri in people with Colic, Infantile, run by BioGaia AB at 3 sites in 3 countries.
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 12 inclusion and 6 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 15 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 3 sites in Ireland, Mexico, Sweden. 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?
Crying and fussing time (time frame: From baseline to Day 7). 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 15 Oct 2026.