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

NCT07236242 | Completed

• 1 other identifier: M1.1.C/C.S./050/2021/01
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Fennel

Outcome Measures

Primary Outcomes (2)

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

  Response is defined as a reduction of at least 50% from baseline in mean daily crying duration. The baseline value is the mean daily crying duration recorded by parents in a 24-hour diary for the two days before treatment initiation, as reported in a questionnaire. The post-treatment value is the mean daily crying duration recorded in the 24-hour diary on the final two days of the one-week treatment period.

  One week

• Changes in bacterial community of infant stool samples

  The bacterial community, assessed by changes in biodiversity indices and the relative proportions of bacterial genera in infant stool samples, will be evaluated before the intervention (day 0) and at the end of the trial (day 7).

  One week

Secondary Outcomes (1)

• Changes in bacterial community of breast milk

  One week

Study Arms (1)

Mother - Infant

EXPERIMENTAL

Breastfeeding women and their infants

Dietary Supplement: Fennel infusion

Interventions

Fennel infusion DIETARY_SUPPLEMENT

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

Mother - Infant

Eligibility Criteria

• Age: 1 Month - 5 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Infants fed with artificial infant formula, use of antibiotics in the last 3 months by mothers or infants.

Sponsors & Collaborators

• IITAA, Universidade dos Açores: lead

Study Sites (2)

Universidade dos Açores, IITAA

Angra do Heroísmo, Azores, 9700-042, Portugal

Location

Universidade dos Açores, FCAA

Angra do Heroísmo, Portugal

Location

MeSH Terms

Conditions

Colic

Condition Hierarchy (Ancestors)

Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Célia C. Silva

  IITAA, Universidade dos Açores

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Single Group Assignment
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: November 19, 2025
• Study Start: September 1, 2021
• Primary Completion: April 30, 2024
• Study Completion: December 31, 2024
• Last Updated: November 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PT (2)