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Fennel tea for moms may calm colicky infants

NCT ID NCT07236242

Symptom relief Sponsor: IITAA, Universidade dos Açores Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looked at whether breastfeeding mothers drinking fennel tea could reduce colic in their babies. 22 mothers drank one liter of fennel infusion daily for a week and tracked their infants' crying and fussiness. Researchers also checked changes in breast milk and baby stool bacteria. The goal was to see if this simple remedy could ease 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
fennel infusion (tea made from fennel seeds)
What this could lead to
If it works, this could offer a simple, natural way for breastfeeding mothers to help ease their baby's colic symptoms.
What could go wrong
This was a very small study with only 22 participants and no placebo group, so results may not be reliable. The effect might be due to chance or the mother's attention rather than the fennel itself.

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

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

22 people

The number who actually took part.

Started

Sep 2021

Finished

Dec 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 month to 5 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * 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.

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Conditions

The condition(s) this trial relates to.

Colic

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Colic, infantile

Contacts and locations

Locations

  • Universidade dos Açores, FCAA

    Angra do Heroísmo, Portugal

  • Universidade dos Açores, IITAA

    Angra do Heroísmo, Azores, 9700-042, Portugal

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