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

NCT07236242 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2025-11-19

No results posted yet for this study

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.

Conditions

  • Colic, Infantile

Interventions

DIETARY_SUPPLEMENT

Fennel infusion

The mothers were asked to drink an infusion of fennel seeds (1 L per day) for one week .

Sponsors & Collaborators

  • IITAA, Universidade dos Açores

    lead OTHER

Principal Investigators

  • Célia C. Silva · IITAA, Universidade dos Açores

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Month
Max Age
5 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-01
Primary Completion
2024-04-30
Completion
2024-12-31

Countries

  • Portugal

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07236242 on ClinicalTrials.gov