Active — Not RecruitingNot Applicable

The Role of Human Milk Oligosaccharides and Microbiomes on Infantile Colic and Atopic Dermatitis in Term Infants

Taiwan300 participantsStarted 2023-08-07

Plain-language summary

Background: Human milk oligosaccharides (HMO) and microbiota are both key factors for infants to shape the gut flora and develop the immune system. Breastfed infant is beneficial to prevent the occurrence of infantile colic (IC) and atopic dermatitis (AD), which may through shaping a healthy microbiota. However, the gut microbiota biomarkers representing IC and AD have not yet been discovered. In addition, the effectiveness of supplement of HMO in infant formula reduce the incidence of IC and AD in infants is still debate.

Who can participate

Age range

1 Day

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

. New born
. Gestational age of \>= 37 weeks
. birth weight greater than 2500 gm

Exclusion criteria

. Born with Perinatal insults
. Mother with antimicrobial agents 1 month before delivery
. Congenital abnormalities related to growth
. Major disease admitted to Level II or NICU

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

Incidence of IC and AD will be compared between three groups

Timeframe: The 1 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 2 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 4 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 6 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 12 months after birth follow-up

Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups

Timeframe: Infant stool samples will be collected at various time points from 0 to 1 year of age.

Trial details

NCT IDNCT05992493

SponsorNational Cheng-Kung University Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-08-30

View on ClinicalTrials.gov More Infantile Colic trials

Plain-language summary

Who can participate

Age range

1 Day

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

. New born
. Gestational age of \>= 37 weeks
. birth weight greater than 2500 gm

Exclusion criteria

. Born with Perinatal insults
. Mother with antimicrobial agents 1 month before delivery
. Congenital abnormalities related to growth
. Major disease admitted to Level II or NICU

What they're measuring

Incidence of IC and AD will be compared between three groups

Timeframe: The 1 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 2 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 4 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 6 months after birth follow-up

Incidence of IC and AD will be compared between three groups

Timeframe: The 12 months after birth follow-up

Next-generation sequencing analysis-based differences on gut microbiota in infants between three groups

Timeframe: Infant stool samples will be collected at various time points from 0 to 1 year of age.