Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements

Official title

Growth, Tolerance, and Functional Biomarkers in Healthy Infants Receiving Dietary Supplements: A Double-blind, Randomized Placebo-controlled Nutritional Study

Overview

This is a double-blind, randomized, placebo-controlled nutritional study aimed at investigating growth, tolerance, and functional biomarkers in healthy infants receiving dietary supplements from birth to 2.5 months of age

Detailed description

This is a double-blind, randomized, placebo-controlled nutritional study in healthy term infants of all feeding types. Approximately 327 infants aged 14 to 28 days at enrollment will be recruited and followed up until 2.5 months of age.

The 8-weeks interventional period will be followed by a 4-week follow-up period. The total duration of the study is approximately 3 months.

The primary objective of this clinical study is to demonstrate non-inferior weight gain from enrollment until 8 weeks of intervention in healthy infants randomized into 3 experimental groups of single probiotic, multi-probiotic, and control group.

The secondary objectives will include growth patterns, gastrointestinal tolerance, gastrointestinal related outcomes, fecal microbiome composition, fecal metabolic status, and biomarkers of gut and immune health as well as safety outcomes from enrollment until 4 weeks after last consumption of the investigational product.

Interventions

• Dietary supplement Probiotic dietary supplement
  Probiotic dietary supplement administered once per day
• Dietary supplement Placebo dietary supplement
  Placebo dietary supplement administered once per day

Primary outcome measures

• Weight gain velocity [Time frame: From baseline (V1) to 2.5 months (V3)]

Secondary outcome measures (12)

• Growth Measure: Weight [Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)]
• Growth Measure: Length [Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)]
• Growth Measure: Head circumference [Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Gastrointestinal Symptom Questionnaire (IGSQ) [Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Frequency [Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Stool Consistency [Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Crying and Sleeping [Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: volume of formula consumed per day/number of breastmilk feeds per day [Time frame: At baseline (V1; 1-day retrospective record) and 1.5 and 2.5 months (V2 and V3; 3-day prospective diary)]
• Gastrointestinal Tolerance and Gastrointestinal Related Symptoms: Infant Colic Questionnaire (ColiQ) [Time frame: At baseline (V1), 1.5 months (V2), and 2.5 months (V3)]
• Fecal Microbiome: Abundance of Probiotic Strains [Time frame: At baseline (V1) and 2.5 months (V3)]
• Fecal Microbiome: Overall Compositional Profile [Time frame: At baseline (V1) and 2.5 months (V3)]
• Fecal Metabolic Status: Fecal pH [Time frame: At baseline (V1) and 2.5 months (V3)]

Eligibility criteria

Inclusion criteria

• Written informed consent has been obtained from at least one parent (or legally acceptable representative \[LAR\])
• Parent(s) / LAR(s) must be able to provide evidence of parental authority and identity
• Parent(s) / LAR(s) must understand the informed consent form and other study documents
• Parent(s) / LAR(s) are willing and able to comply with scheduled visits and the requirements of the study protocol
• Parent(s) / LAR(s) can be contacted directly by telephone throughout the study
• Parent(s) / LAR(s) must be able to temporarily store stool samples in a household freezer
• Infants may be exclusively breastfed, exclusively formula-fed, or mixed fed with both breast milk and infant formula in any proportion. Parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding until the end of the study period:

• For exclusively breastfed infants: parents must intend to continue exclusive breastfeeding. As defined by the World Health Organization, exclusive breastfeeding means that the infant receives only breast milk. No other liquids or solids are given (not even water) with the exception of oral rehydration solution, or drops/syrups of vitamins, minerals, or medicines.
• For formula-fed infants (either exclusively or mixed-fed): parent(s) / LAR(s) must intend to maintain the infant's current mode of feeding, plus:

• Parents / LAR(s) must have previously and independently decided to use formula
• Infant must be consuming and tolerating a standard cow's milk infant formula not containing probiotics at the time of enrollment
• Infant must be healthy based on medical history and physical examination
• Infant full-term gestational birth (born 37 weeks, 0 days through 41 weeks, 6 days of gestation)
• Infant singleton birth
• Infant postnatal age ≥ 14 and ≤ 28 days (date of birth = day 0)
• Infant birth weight is appropriate for gestational age (≥ 2500 and ≤ 4500 grams)

Exclusion criteria

• Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol
• 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:

• Evidence of major congenital malformations (e.g., cleft palate, extremity malformation)
• Suspected or documented systemic or congenital infections (e.g., human immunodeficiency virus, cytomegalovirus, syphilis)
• Previous or ongoing antibiotic usage by the infant, except when given for prophylactic reasons (e.g., erythromycin ophthalmic ointment)
• Immunocompromised infants and those who have a central venous catheter
• History of admission to the Neonatal Intensive Care Unit, except for admission for jaundice phototherapy
• Known or suspected allergy to milk (including lactose) or soy
• 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
• Infants who are currently receiving or who have received any probiotic supplements or infant formula containing probiotics prior to enrollment
• Infants who are currently receiving or who have 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), or gastric acid secretion
• Infants whose parent(s) / LAR(s) have not reached the legal age of majority (18 years old)
• Infants who are currently or who previously participated in another interventional clinical study
• Parent(s) / LAR(s) with family or hierarchical relationships with the research team members

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07630584 · 2403INF

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗