Prospective Study to Determine the Factors Influencing Infant Colic (NCT05271747) | Clinical Trial Compass
CompletedNot Applicable
Prospective Study to Determine the Factors Influencing Infant Colic
Mexico, Spain112 participantsStarted 2019-03-01
Plain-language 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.
Who can participate
Age range
2 Weeks – 12 Weeks
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.