Breastfed Babies' immune secrets revealed in new study
NCT ID NCT06708559
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
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.
- Can a chewable postbiotic tablet keep plaque and gum inflammation at bay?
- Can a new oral drug safely help older adults manage weight?
- Can a protein powder with creatine and fiber boost everyday Well-Being?
- Green tech or hidden stress? bus Drivers' hearts monitored behind the wheel
- Shout it out: can growls and screams raise pain tolerance?
- Scientists probe why brain stimulation works for some and not others