Efficacy of a Dietary Supplement in Infants

Microbiome and Health-related Effects of a Dietary Supplement in Infants: a Double-blind, Randomized, Placebo-controlled Nutritional Study.

This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants. The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement.

This is a double-blind, randomized, placebo-controlled nutritional study of healthy term infants, consisting of 2 randomized parallel arms: experimental group (EG) receiving a dietary supplement and a control group (CG) receiving a placebo supplement.

The population under investigation is healthy infants aged 5 months +/- 1 week at the time of clinic visit 1.

The planned sample size for this study is 172 infants (86 per study group). Each investigational product (EG and CG) will be provided in powder form and packaged in single dose stick packs. The powder will be dissolved in lukewarm formula or body temperature breastmilk and fed orally to the infants using a provided infant feeding beaker.

The primary objective of the trial is to demonstrate a favorable change in fecal microbiome composition in infants receiving a dietary supplement compared to infants receiving a placebo supplement from enrolment until 5 months of intervention.

In addition, fecal metabolic biomarkers, gastrointestinal (GI) related outcomes, blood markers of immune health, fecal markers of gut and immune health, bone quality, other anthropometric measurements, dietary pattern and infant illness and infection outcomes will be assessed/measured.

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