Colic, InfantileBabyGutNCT07236242
Effect of Breastfeeding Mothers Drinking Fennel Seed Infusion on Infants With Colic
A study testing Fennel infusion in people with Colic, Infantile, run by IITAA, Universidade dos Açores at 2 sites in Portugal.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 5 months
- Conditions the study is for
- Colic, Infantile
- What is being tested?
- Fennel infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesPortugal
- Study dates
- 1 Sep 2021to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 5 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Infants fed with artificial infant formula, use of antibiotics in the last 3 months by mothers or infants.
Trial locations and contacts
2 sites in 1 country.
Portugal2 sites
Universidade dos Açores, IITAA
Angra do Heroísmo, Azores, 9700-042
Universidade dos Açores, FCAA
Angra do Heroísmo
About this study
Official title: Impact of Mothers Consuming a Fennel Infusion on Infantile Colic in Exclusively Breastfed Infants
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.
Read more
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.
Read the detailed description
The project will investigate the effect of maternal ingestion of fennel infusion and the associated microbial changes in milk and the infant gut. A beneficial effect has been reported by mothers as part of popular medicine, but this has not been studied in controlled trials.
The trial aims to elucidate the mechanisms by which fennel compounds exert a colic-reducing effect in babies via breast milk. The investigators will determine whether an orally administered fennel seed infusion affects monitored symptoms or microbial parameters, and whether the composition of the fecal microbiota differs between colicky and non-colicky infants. Mothers will be asked to drink an infusion of fennel seeds (Foeniculum vulgare var. dulce) (20 g/L, 1 L per day) for one week. Samples of milk and feces will be collected at the beginning of treatment (day 0) and at the end of treatment (day 7) for microbiome analysis.
Samples will be prepared for Illumina sequencing by 16S rRNA gene amplification of the bacterial community. Raw reads will be extracted from the Illumina MiSeq System in fastq format and processed in the QIIME2 package using DADA2 to infer amplicon sequence variants (ASVs) and their relative abundances across samples. Taxonomy will be assigned to ASVs with the q2 feature-classifier using a pre-trained Naïve Bayes classifier of the Silva database. For species assignment, sequences will be further analyzed using the GenBank DNA database with the Basic Local Alignment Search Tool (BLAST) algorithm.
Alpha diversity will be determined using the number of taxa, individuals - amplicon sequence variants (ASVs), dominance (1-Simpson index), Margalef's richness index, evenness, and Chao1. Alpha diversity results will be compared before and after the intervention using the Wilcoxon signed-rank test. Beta diversity will be measured using principal coordinate analysis (PCoA) based on Bray-Curtis distance matrices for ASVs and PERMANOVA. The Wilcoxon signed-rank test will be used to compare normalized ASVs at the genus and species levels before the intervention (day 0) and after (day 7).
- Conditions
- Colic, Infantile
- Being tested
- Fennel infusion
- Keywords
- Fennel
- Medical subject headings
- Colic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fennel infusionDietary supplement
The mothers were asked to drink an infusion of fennel seeds (1 L per day) for one week .
| Study group | Role | What they receive |
|---|---|---|
| Mother - Infant | Experimental | Breastfeeding women and their infants Receives: Dietary Supplement: Fennel infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: One week
Secondary outcomes (1)
Changes in bacterial community of breast milk
The bacterial community, assessed by changes in biodiversity indices and the relative proportions of bacterial genera in breast milk samples, will be evaluated before the intervention (day 0) and at the end of the trial (day 7).
Measured: One week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start1 Sep 2021
- Primary completion30 Apr 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colic, InfantileStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- IITAA, Universidade dos Açores
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Celia Costa Silva, IITAA, Universidade dos Açores
- Investigators
- Célia C. Silva, Principal investigator, IITAA, Universidade dos Açores
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236242
- Sponsor's protocol ID
- M1.1.C/C.S./050/2021/01
- Acronym
- BabyGut
- Status last verified
- Sep 2025
- First submitted
- 26 Sep 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD used in the results publication.
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Mothers Consuming a Fennel Infusion on Infantile Colic in Exclusively Breastfed Infants
- ClinicalTrials.gov ID
- NCT07236242
- Acronym / sponsor ID
- BabyGut / M1.1.C/C.S./050/2021/01
- Conditions
- Colic, Infantile
- Keywords
- Fennel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- IITAA, Universidade dos AçoresUniversity, hospital or other
- Study start
- 1 Sep 2021 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The project will investigate the effect of maternal ingestion of fennel infusion and the associated microbial changes in milk and the infant gut. A beneficial effect has been reported by mothers as part of popular medicine, but this has not been studied in controlled trials.
The trial aims to elucidate the mechanisms by which fennel compounds exert a colic-reducing effect in babies via breast milk. The investigators will determine whether an orally administered fennel seed infusion affects monitored symptoms or microbial parameters, and whether the composition of the fecal microbiota differs between colicky and non-colicky infants. Mothers will be asked to drink an infusion of fennel seeds (Foeniculum vulgare var. dulce) (20 g/L, 1 L per day) for one week. Samples of milk and feces will be collected at the beginning of treatment (day 0) and at the end of treatment (day 7) for microbiome analysis.
Samples will be prepared for Illumina sequencing by 16S rRNA gene amplification of the bacterial community. Raw reads will be extracted from the Illumina MiSeq System in fastq format and processed in the QIIME2 package using DADA2 to infer amplicon sequence variants (ASVs) and their relative abundances across samples. Taxonomy will be assigned to ASVs with the q2 feature-classifier using a pre-trained Naïve Bayes classifier of the Silva database. For species assignment, sequences will be further analyzed using the GenBank DNA database with the Basic Local Alignment Search Tool (BLAST) algorithm.
Alpha diversity will be determined using the number of taxa, individuals - amplicon sequence variants (ASVs), dominance (1-Simpson index), Margalef's richness index, evenness, and Chao1. Alpha diversity results will be compared before and after the intervention using the Wilcoxon signed-rank test. Beta diversity will be measured using principal coordinate analysis (PCoA) based on Bray-Curtis distance matrices for ASVs and PERMANOVA. The Wilcoxon signed-rank test will be used to compare normalized ASVs at the genus and species levels before the intervention (day 0) and after (day 7).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mother - Infant | Experimental | Dietary Supplement: Fennel infusionBreastfeeding women and their infants |
Who may qualify
- Ages
- 1 month to 5 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Infants fed with artificial infant formula, use of antibiotics in the last 3 months by mothers or infants.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fennel infusionThe mothers were asked to drink an infusion of fennel seeds (1 L per day) for one week . | Dietary supplement | Mother - Infant |
Primary outcome
Proportion of participants with a ≥50% reduction in daily crying duration as measured by a parent-reported 24-hour diary.
Time frame: One week
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.
Changes in bacterial community of infant stool samples
Time frame: One week
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).
1 secondary outcome
Changes in bacterial community of breast milk
Time frame: One week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No. IPD used in the results publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Célia C. Silva principal investigator
IITAA, Universidade dos Açores
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fennel infusion in people with Colic, Infantile, run by IITAA, Universidade dos Açores at 2 sites in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a ≥50% reduction in daily crying duration as measured by a parent-reported 24-hour diary. (time frame: One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.