Infant ColicNCT05271747
Prospective Study to Determine the Factors Influencing Infant Colic
A study testing AB-Kolicare and Reuteri gotas in people with Infant Colic, run by AB Biotics, SA at 4 sites in 2 countries.
Trial summary
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days. Read more about this study
- Who is it for?
- Ages 2 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Colic
- What is being tested?
- AB-Kolicare and Reuteri gotas
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 1 Mar 2019to 30 Dec 2023
- 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 2 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants from 2 to 12 weeks of age
- Infants diagnosed with infant colic following Roma IV criteria for clinical research
- Gestational age greater or equal to 37 weeks
- Birth weight greater than 2100 g
- Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.
Who cannot join
- Infants that are fed with solid food.
- Infants whose parents can not appropriately follow the requirements of the study.
- Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
- Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
- Infants fed extensively hydrolyzed infant formula
- Specific medication use for the treatment of functional digestive disorder: antacids (IBP type or H2 blockers), laxative Polyethylene glycol (8PEG), lactulose, magnesia), lactase or simeticone.
- Infants going through therapies related with acupuncture, homeopathy, medicinal herbs, or taking anti-inflammatory or antispasmodic drugs.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain3 sites
HM Hospitals
Barcelona
University Hospital Santa Lucía
Cartagena, Murcia, 30202
Hm Hospitals
Madrid
About this study
Official title: Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
Read the detailed description
Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).
Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.
Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.
- Conditions
- Infant Colic
- Being tested
- AB-Kolicare, Reuteri gotas
- Keywords
- Infant colic, probiotic
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AB-KolicareDietary supplement
Probiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 for 21 days, 5 drops/day preferably during the first intake of milk
Reuteri gotasDietary supplement
Probiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal.
| Study group | Role | What they receive |
|---|---|---|
| AB- Kolicare | Active comparator | Probiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority Receives: Dietary Supplement: AB-Kolicare |
| Reuteri gotas | Active comparator | Probiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority Receives: Dietary Supplement: Reuteri gotas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of crying and fussing
Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.
Measured: 21 days
Percent of responders
Percent of subjects whose change in crying time is equal or larger than 50% from baseline
Measured: 7, 14, 21 days
Secondary outcomes (7)
Number of regurgitations
Change in daily number of regurgitations
Measured: 21 days
Bowel movements
Change in daily number of bowel movements
Measured: 21 days
Food intake
Frequency of food intake
Measured: 21 days
Parent's anxiety and depression
Change in parent's anxiety and depression score measured through Hospital Anxiety and Depression Scale (HADS). The HADS questionnaire has 7 items each for depression and anxiety subscales. Scoring for each item ranges from zero to three, with three denoting highest anxiety or depression level. A total subscale score of >8 points out of a possible 21 denotes considerable symptoms of anxiety or depression.
Measured: baseline, day 21
Fecal microbiome
Changes on fecal microbiome evaluated by RNA ribosomal 16S genes analysis
Measured: baseline, day 21
Fecal calprotectin
Change on calprotectin in feces
Measured: baseline, day 21
Adverse events
Frequency of adverse events reported on dairy report form after randomization and until day 21
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Mar 2019
- Primary completion30 Dec 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicentric, single-blind trial in infants between 2 and 12 weeks of age diagnosed with infant colic, who will be allocated to receive one of the two comercialized probiotic products B. Longum and P. Pentosaceus (branch one) or L. Reuteri (branch two) for 21 days
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- AB Biotics, SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271747
- Sponsor's protocol ID
- Pro-care 2
- Status last verified
- Mar 2024
- First submitted
- 28 Feb 2022
- Last updated
- 24 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
PubMed 27147121Moreno-Villares JM, Andrade-Platas D, Soria-Lopez M, Colome-Rivero G, Catalan Lamban A, Martinez-Figueroa MG, Espadaler-Mazo J, Valverde-Molina J. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. Eur J Pediatr. 2024 Dec;183(12):5371-5381. doi: 10.1007/s00431-024-05806-x. Epub 2024 Oct 11.
PubMed 39390276
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Determine the Factors Influencing Infant Colic Course in Infants Taking Probiotics
- ClinicalTrials.gov ID
- NCT05271747
- Acronym / sponsor ID
- Pro-care 2
- Conditions
- Infant Colic
- Keywords
- Infant colic, probiotic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- AB Biotics, SAIndustry (pharma, biotech, devices)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 9 Mar 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.
Randomized study to determine the effect of a commercialized combination of 2 probiotic strains (Bifidobacterium Longum and Pediococcus pentosaceus) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria when administered for 21 days.
Detailed description
Randomized, single-blind, interventional study with two parallel groups to determine the effect of two different commercialized probiotic products (Lactobacillus reuteri or a combination of two different strains (Bifidobacterium longum and Pediococcus pentosaceus)) and the impact of feeding type in babies diagnosed with colic under Roma IV criteria. Infants meeting selection criteria are randomized 1:1 and stratified according to the type of feeding (breastfed or formula).
Probiotics are administered once a day (5 drops) for 21 days. Parents must document clinical parameters during this 21 days. This parameters include colic-related symptoms, other functional gastrointestinal disorders symptoms, parental anxiety and adverse events.
Moreoever, stool samples are collected to determine intestinal microbiota and calprotectin levels.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Randomized, multicentric, single-blind trial in infants between 2 and 12 weeks of age diagnosed with infant colic, who will be allocated to receive one of the two comercialized probiotic products B. Longum and P. Pentosaceus (branch one) or L. Reuteri (branch two) for 21 days
| Arm | Type | Receives |
|---|---|---|
| AB- Kolicare | Active comparator | Dietary Supplement: AB-KolicareProbiotic multi-strain formulation comprising Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 in sunflower oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority |
| Reuteri gotas | Active comparator | Dietary Supplement: Reuteri gotasProbiotic single-strain formulation comprising Lactobacillus reuteri DSM17938 in sunflower oil and medium-chain triglyceride oil. Probiotic strains have Qualified Presumption of Safety (QPS) status by European Food Safety Authority |
Who may qualify
- Ages
- 2 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy infants from 2 to 12 weeks of age
- Infants diagnosed with infant colic following Roma IV criteria for clinical research
- Gestational age greater or equal to 37 weeks
- Birth weight greater than 2100 g
- Exclusively breastfed or formula fed with a maximum of one daily intake of breast milk.
Key exclusion criteria (7 listed)
- Infants that are fed with solid food.
- Infants whose parents can not appropriately follow the requirements of the study.
- Antibiotics or probiotics administration to the infant (including infant formula with probiotics) 2 weeks prior the inclusion in the study.
- Breastfed infants whose mothers have taken antibiotics and/or probiotics 2 weeks prior the inclusion in the study.
- Infants fed extensively hydrolyzed infant formula
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 |
|---|---|---|
| AB-KolicareProbiotic multi-strain formulation containing Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330 for 21 days, 5 drops/day preferably during the first intake of milk | Dietary supplement | AB- Kolicare |
| Reuteri gotasProbiotic single-strain formulation containing Lactobacillus reuteri DSM17938 for 21 days, 5 drops/day before or after any daily meal. | Dietary supplement | Reuteri gotas |
Primary outcome
Duration of crying and fussing
Time frame: 21 days
Change on daily crying and fussing minutes measured through Barr ( Barr et al., 1988).validated crying and fussing scale. The Barr scale consists of a 24 hours dairy where parents paint number of hours crying and fussing every day. Results show the number of hours of crying and fussing per day.
Percent of responders
Time frame: 7, 14, 21 days
Percent of subjects whose change in crying time is equal or larger than 50% from baseline
7 secondary outcomes
Number of regurgitations
Time frame: 21 days
Bowel movements
Time frame: 21 days
Food intake
Time frame: 21 days
Parent's anxiety and depression
Time frame: baseline, day 21
Fecal microbiome
Time frame: baseline, day 21
Fecal calprotectin
Time frame: baseline, day 21
Adverse events
Time frame: 21 days
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 24 Feb 2026.
- Background: PubMed 27147121Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available.
- Derived from this study: PubMed 39390276Moreno-Villares JM, Andrade-Platas D, Soria-Lopez M, Colome-Rivero G, Catalan Lamban A, Martinez-Figueroa MG, Espadaler-Mazo J, Valverde-Molina J. Comparative efficacy of probiotic mixture Bifidobacterium longum KABP042 plus Pediococcus pentosaceus KABP041 vs. Limosilactobacillus reuteri DSM17938 in the management of infant colic: a randomized clinical trial. Eur J Pediatr. 2024 Dec;183(12):5371-5381. doi: 10.1007/s00431-024-05806-x. Epub 2024 Oct 11.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AB-Kolicare and Reuteri gotas in people with Infant Colic, run by AB Biotics, SA at 4 sites in 2 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 5 inclusion and 7 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 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, Mexico. 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?
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?
Duration of crying and fussing (time frame: 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05271747, which also lists 2 linked publications.
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 24 Feb 2026.