Can probiotics calm a crying baby? new study investigates
NCT ID NCT05271747
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two different probiotic supplements in 112 healthy infants diagnosed with colic to see if they could reduce daily crying and fussing. Babies received either a multi-strain probiotic or a single-strain probiotic for 21 days. The researchers also tracked feeding type, regurgitation, bowel movements, and parent anxiety to understand what influences colic symptoms.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Probiotic multi-strain formulation (Bifidobacterium longum CECT7894 and Pediococcus pentosaceus CECT8330) and probiotic single-strain formulation (Lactobacillus reuteri DSM17938)
- What this could lead to
- If successful, this could point toward a probiotic option to reduce crying and fussing in babies with colic, potentially easing stress for parents.
- What could go wrong
- This is a small, completed study with 112 infants, so results may not apply to all babies. Probiotics may not work for every case of colic, and individual responses can vary.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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112 people
The number who actually took part.
- Started
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Mar 2019
- Finished
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Dec 2023
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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2 to 12 weeks
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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HM Hospitals
Barcelona, Spain
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Hm Hospitals
Madrid, Spain
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Hospital Medica Sur, room 108, tower 2
Mexico City, 14050, Mexico
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University Hospital Santa Lucía
Cartagena, Murcia, 30202, Spain
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