CompletedNot Applicable

Effect of Breastfeeding Mothers Drinking Fennel Seed Infusion on Infants With Colic

Portugal22 participantsStarted 2021-09-01

Plain-language summary

The goal of this clinical trial is to determine whether a fennel-water infusion taken by mothers reduces colic in breastfed infants. The study will also assess the effect of the fennel infusion on the mothers' milk and the gut microbiota of the infants. The main questions it aims to answer are: * Does a fennel-water infusion taken by mothers reduce colic in breastfed infants? * What changes occur in the gut microbiota of responders (participants whose infants show reduced colic symptoms after the intervention)? Researchers will evaluate changes in the microbiota of breast milk and the stool of breastfed infants after the mothers consume a fennel infusion. Participants-mothers of infants-will: * Take 1 L of fennel infusion daily for 7 days. * Keep a diary of infant colic symptoms, including time spent crying, and periods of fussiness or irritability without a definite explanation. * Provide breast milk and infant stool samples before treatment (day 0) and at the end of treatment (day 7) for analysis of microbial communities.

Who can participate

Age range

1 Month – 5 Months

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: * Breastfed infants aged 1 to 5 months, full-term (gestational age between 38 and 42 weeks) of both sexes, diagnosed with infantile colic. The ROME IV criteria for diagnosed infant colic were used in this study. Exclusion Criteria: * Infants fed with artificial infant formula, use of antibiotics in the last 3 months by mothers or infants.

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.

What they're measuring

Proportion of participants with a ≥50% reduction in daily crying duration as measured by a parent-reported 24-hour diary.

Timeframe: One week

Changes in bacterial community of infant stool samples

Timeframe: One week

Trial details

NCT IDNCT07236242

SponsorIITAA, Universidade dos Açores

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-04-30

View on ClinicalTrials.gov More Colic, Infantile trials