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Breastfed Babies' immune secrets revealed in new study

NCT ID NCT06708559

What the study statuses mean

This study's is highlighted.

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 21, 2026 · Updated 4 times

Summary

This study looks at how the immune system and gut bacteria develop in 60 healthy Filipino infants who are breastfed from birth to 12 months old. Researchers will collect blood and stool samples to measure immune markers and gut health. An optional follow-up of about 2 years may provide longer-term insights.

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.

Participants

60 people

The number who actually took part.

Started

Nov 2024

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Who is studied

Approximately 60 healthy breastfed infants aged ≥14 to ≤35 days at enrollment. To ensure balanced sex representation of the study population, approximately 30 males and 30 females will be enrolled in the study.

Ages

14 to 35 days

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: 1. Written informed consent is obtained from parent(s)/ legally authorized representative(s) (LAR(s)). 2. Parent(s)/ LAR(s) must be able to provide evidence of parental authority and identity. 3. Parents/ LARs must understand the informed consent and other study documents. 4. Infants whose parent(s)/ LAR (s) has consented to blood collection as per protocol. 5. Able to temporarily store stool samples in a household freezer. 6. Infants whose parent(s)/LAR(s) are willing and able to comply with scheduled visits, and the requirements of the study protocol. 7. Infants whose parent(s)/LAR(s) can be contacted directly by telephone throughout the study. 8. Infants must meet all the following inclusion criteria to be eligible for enrollment into the study: 1. Healthy term infant (≥37 weeks of gestation) 2. At enrollment visit, postnatal age ≥14 to ≤35 days (date of birth = day 0) 3. Birth weight is appropriate for gestational age (i.e., ≥ 2500g and ≤ 4500g) 4. Infant has exclusively received breastmilk from birth to enrollment, and parent intends to continue exclusive breastmilk feeding until infant age 6 months. Exclusion Criteria: 1. A medical condition or history that could increase the risk associated with study participation or interfere with the interpretation of study results, including: 1. Evidence of major congenital malformations (e.g., cleft palate, extremity malformation). 2. Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis). 3. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgment of the investigator, would make the infant inappropriate for entry into the study. Of note, children who are normally healthy but at the time of enrolment suffering from acute illness in a minor condition which are common in childhood and do not require some of the exclusionary medication mentioned below can be enrolled. 2. Presently receiving or have received prior to enrolment any of the following: medication(s) or supplement(s) which are known or suspected to affect the following: fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes); stool microbiota and characteristics (e.g., oral, or systemic antibiotics, glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g., insulin or growth hormone); gastric acid secretion. 3. Infants whose parent(s) has(ve) not reached legal age of majority (18 years old) upon enrollment. 4. Currently participating or having participated in any interventional clinical trials since birth.

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Conditions

The condition(s) this trial relates to.

Breast Feeding

As listed by the trial registrant

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

Contacts and locations

Locations

  • Asian Hospital and Medical Center

    Manila, Manila, 1780, Philippines

More trials for these conditions

Other studies related to the condition(s) this trial covers.