Clinical trial NCT04765852: Growth, Safety and Efficacy of a Probiotic Supplement
Official title: Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Probiotic Supplement
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2021-02-23
Enrollment: 228
Sex: ALL
Minimum age (years): 14
Maximum age (years): 21
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The primary objective of the study is to demonstrate the safety of a daily high dose of a probiotic supplement by comparing the growth (weight gain, g/day) of formula-fed and/or breastfed infants in high dose group versus placebo group from enrolment to 8 weeks of intervention

Detailed description: This is a randomized, placebo-controlled, double-blind study of healthy term infants, consisting of three randomized arms: placebo control group, high dose experimental group, and low dose experimental group. The study population, approximately 228, are infants 14 - 21 days of age who are formula-fed and/or breastfed who is aligned with the intended target population for a probiotic supplement. Placebo and probiotic supplements will be mixed with formula or breastmilk and fed orally using a feeding cup or syringe. All enrolled infants will participate in the trial for approximately 8 weeks.

Eligibility criteria: Inclusion Criteria:

1. Evidence of personally signed and dated informed consent document indicating that the infant's parent(s)/ legally accepted representatives LAR have been informed of all pertinent aspects of the study.
2. Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
3. Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
4. Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
5. Infants whose parent(s)/LAR have access to a working freezer.
6. Infants must meet all the following inclusion criteria to be eligible for enrolment into the study:

   1. Healthy term (37-42 weeks of gestation) infant at birth.
   2. At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
   3. Birth weight ≥ 2500g and ≤ 4500g.
   4. Breastfed and/or formula-fed infants (including exclusively and mixed fed breast- and formula-fed infants) whose parent(s)/LAR intent not to change the feeding regimen until the study end at 8 weeks of intervention.
   5. Formula-fed infants and their parent(s)/LAR must have independently elected, before enrolment not to breastfeed and their infant must tolerate a standard cow's milk infant formula not containing any probiotics at time of enrolment.

Exclusion Criteria:

1. Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
2. Infants receiving complementary foods or liquids defined as 4 or more teaspoons per day or approximately 20 g per day of complementary foods or liquids at or prior to enrollment.
3. Infants who have 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. History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
   4. Other 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.
4. Infants who are presently receiving or have received prior to enrollment probiotic supplements or 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 characteristics (e.g., glycerin suppositories, bismuth-containing medications, docusate, Maltsupex, or lactulose); growth (e.g. insulin or growth hormone); gastric acid secretion.
5. Currently participating or having participated in another clinical trial since birth.

Primary outcomes:
measure: Safety of high dose probiotic supplement (weight gain)
timeFrame: Day 56
Secondary outcomes:
measure: Efficacy of two different doses of probiotic supplement
timeFrame: Day 0, Day 25-27, Day 53-55
Other outcomes:
measure: Additional growth parameters: weight
timeFrame: Day 0, Day 28, Day 56
measure: Additional growth parameters: length
timeFrame: Day 0, Day 28, Day 56
measure: Additional growth parameters: head circumference
timeFrame: Day 0, Day 28, Day 56
measure: Additional growth parameters: body mass index
timeFrame: Day 0, Day 28, Day 56
measure: Fecal microbiome composition
timeFrame: Day 0, Day 28, Day 56
measure: Bifidobacteria colonization
timeFrame: Day 0, Day 28, Day 56
measure: Fecal microbiome: Continuation of bifidobacteria colonization
timeFrame: Day 84
measure: Fecal metabolic profile: Fecal pH
timeFrame: Day 0, Day 28, Day 56
measure: Fecal metabolic profile: Fecal organic acids
timeFrame: Day 0, Day 28, Day 56
measure: Fecal metabolic profile: gut microbiota-derived metabolites
timeFrame: Day 0, Day 28, Day 56
measure: Biological response of selected fecal metabolites
timeFrame: Day 0, Day 28, Day 56
measure: Fecal markers of immune health and gut barrier
timeFrame: Day 0, Day 28, Day 56
measure: GI tolerance
timeFrame: Day 0, Day 28, Day 56
measure: GI-related behaviors: Stool frequency
timeFrame: Day 0, Day 25-27, Day 53-55
measure: GI-related behaviors: Stool consistency
timeFrame: Day 0, Day 25-27, Day 53-55
measure: GI-related behaviors: Incidence of spitting-up
timeFrame: Day 0, Day 25-27, Day 53-55
measure: GI-related behaviors: Incidence of flatulance
timeFrame: Day 0, Day 25-27, Day 53-55
measure: GI-related behaviors: Crying time
timeFrame: Day 0, Day 25-27, Day 53-55
measure: GI-related behaviors: Sleep time
timeFrame: Day 0, Day 25-27, Day 53-55
Locations:
city: Muntinlupa
country: Philippines
facility: Asian Foundation for Tropical Medicine, Inc.
Study officials:
References: