Healthy Infants
Conditions
Keywords
Dietary Supplement
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTExperimental Group
Dietary supplement in powder form
OTHERControl Group (CG)
Placebo dietary supplement in powder form
Sponsors
Société des Produits Nestlé (SPN)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Unique (individual) coding of the study products
Intervention model description
Double-blind, randomized, placebo-controlled nutritional study.
Eligibility
Sex/Gender
ALL
Age
19 Weeks to 21 Weeks
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probiotic abundance | At 5 months (V4) of intervention | Fecal probiotic abundance |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fecal metabolic biomarker | At baseline (V1), 3 months (V3), and 5 months (V4) of intervention. | To assess changes in key fecal metabolic biomarkers such as fecal water-soluble vitamins, fecal organic acids, and other fecal metabolites. |
| Growth parameter: Weight | At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention. | Weight in grams and corresponding weight-for-age Z-score according to WHO growth standards |
| Growth parameter: Length | At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention. | Length in cm and corresponding weight-for-age Z-score according to WHO growth standards |
| Growth parameter: Head circumference | At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention. | Head circumference in cm and corresponding head circumference-for-age Z-score according to WHO growth standards |
| GI-related Behavior: Infant Gastrointestinal Symptom Questionnaire (IGSQ) | At baseline (V1), 1 month (V2), 3 months (V3) and 5 months (V4) of intervention. | The questionnaire is composed of 13 questions, categorized into 5 symptom domains of stooling, vomiting/spitting-up, crying, fussiness, and flatulence. The total score can range from 13 to 65 with lower scores indicating lower GI symptom burden. |
| GI-related behavior: Stool frequency | 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention | Stool frequency recorded via the GI Symptom and Behavior Diary |
| GI-related behavior: Stool consistency | 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention | Stool consistency recorded on a 5-point scale (1: watery, 5: hard) via the GI Symptom and Behavior Diary |
| GI-related behavior: Crying and sleeping | 1-day retrospective (V1) and 3-day prospective (V2, V3 and V4) of intervention | Crying and sleeping time via the GI Symptom and Behavior Diary |
| Fecal microbiota | At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention. | Overall fecal microbiota composition, diversity, and function. |
| Bone quality | At baseline (V1), 3 months (V3), and 5 months (V4) of intervention. | Tibia bone transmission time and speed of sound. Tibia length assessed using a measuring tape. |
| Dietary intake: Food record | 3 consecutive days prior to study visit 3 (age 8 months) and visit 4 (age 10 months) | Dietary intake using a 3-day food record completed at home |
| Dietary intake: Complementary foods | Questionnaire to be completed prospectively starting at age 6 months | Exact timing of the introduction of different types of complementary foods assessed using the Complementary Food Questionnaire |
| Dietary intake: Formula Composition | At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention. | Key aspects of formula composition assessed using a questionnaire at each study visit for formula-fed infants (exclusively or mixed-fed). |
| Fecal markers of gut and immune health: Formula-fed infants only | At 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in exclusively formula-fed infants only. | Fecal markers of gut and immune health such as total secretory IgA (sIgA) |
| Fecal markers of gut and immune health: All infants | At baseline (V1), 1 month (V2), 3 months (V3), and 5 months (V4) of intervention in all infants. | Fecal markers of gut and immune health such as fecal pH, fecal calprotectin, fecal α-1-antitrypsin, oral vaccine-specific fecal antibodies. |
| Blood biomarkers | At baseline (V1), 3 months (V3), and 5 months (V4) of intervention. | Blood biomarkers such as immunotyping, plasma immune proteomics, metabolic and anabolic biomarkers, plasma metabolomics, vaccine-specific antibodies, plasma short-chain fatty acids. |
| Neurodevelopment: National Institute of Health (NIH) Baby Toolbox | At 5 months (V4) of intervention | To assess different aspects of infant neurodevelopment |
Countries
Philippines
Contacts
CONTACTQiaoji Li
CONTACTMarie-Annick Hauser
PRINCIPAL_INVESTIGATORDr. Mitzi Trinidad-Aseron
University of Perpetual Help Dalta Medical Center, Philippines
PRINCIPAL_INVESTIGATORDr. Maria Josefa Nantes
Silang Specialists Medical Center, Philippines
Outcome results
None listed