Dietary supplement in healthy infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study randomizes 172 healthy term infants, aged about 5 months, to receive either a dietary supplement or a placebo for five months in parallel groups. The trial uses a double-blind design and measures fecal microbiome composition as the primary outcome, along with fecal and blood biomarkers, GI-related outcomes, bone quality, growth, dietary patterns, and infection data. Nutritional products are provided as single-dose powder sticks dissolved in formula or breast milk and administered at home. The study requires parental consent, adherence to visits, stool sample storage, and ability to blood draw for infants as part of the protocol. The sponsor is SPN and the study is conducted at specific clinical centers in the Philippines.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\])
2. Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
3. Parent(s) / LAR(s) must understand the informed consent form and other study documents
4. Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol including infant blood collection
5. Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
6. Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer
7. Parent(s) / LAR(s) of formula-fed infants (either exclusively or mixed-fed) must have previously and independently decided to use formula and their infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
8. Infant must be healthy based on medical history and physical examination
9. Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days)
10. Infant age 5 months ± 1 week (date of birth = day 0) at time of clinic visit 1
11. Infant birth weight is appropriate for gestational age (i.e., ≥ 2500 and ≤ 4500 grams)

Exclusion Criteria:

1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
2. Infants receiving solid foods or liquids other than breastmilk or infant formula within 4 weeks prior to enrollment
3. Infants who have a medical condition or medical 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. Immunocompromised infants and those who have a central venous catheter
   4. History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy.
   5. Known or suspected allergy to milk (including lactose) or soy
   6. Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the infant inappropriate for entry into the study.
4. Infants who are currently receiving or who have received any probiotic supplements or any infant formula containing probiotics prior to enrollment
5. Infants who are currently receiving or who have previously received any of the following medication(s) or supplement(s) which are known or suspected to affect fat digestion, absorption, and/or metabolism (e.g., pancreatic enzymes), stool characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose), growth (e.g. insulin or growth hormone), microbiome-related endpoints (e.g., prebiotic supplements, antibiotic usage within the past 4 weeks \[not including topical or ophthalmic applications\]), or gastric acid secretion.
6. Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old)
7. Infants who are currently or who previously participated in another interventional clinical study
8. Parent(s) / LAR(s) with family or hierarchical relationships with the research team members

Where it's running

• University of Perpetual Help DALTA Medical Center, Inc.
  Las Piñas, Philippines Recruiting
• Silang Specialist Medical Center
  Silang, Philippines Recruiting

Study contacts

• Principal investigator: Dr. Mitzi Trinidad-Aseron — University of Perpetual Help Dalta Medical Center, Philippines
• Study coordinator: Qiaoji Li
• Email: Qiaoji.Li@rd.nestle.com
• Phone: +861087419794

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Effect of a New Infant Formula on Gut Health in Healthy Infants

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• Effect of a High Fibre Fermented Diet on Breastfed Infant Gut Microbiome

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.