Growth, Safety and Efficacy of a Probiotic Supplement

NCT04765852 | Completed

• 1 other identifier: 20.11.INF
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Conditions

Probiotic Supplement

Outcome Measures

Primary Outcomes (1)

• Safety of high dose probiotic supplement (weight gain)

  Compare the growth (weight gain, g/day) of formula-fed and/or breastfed infants in EG 1 vs. CG from enrolment to 8 weeks of intervention

  Day 56

Secondary Outcomes (1)

• Efficacy of two different doses of probiotic supplement

  Day 0, Day 25-27, Day 53-55

Other Outcomes (19)

• Additional growth parameters: weight

  Day 0, Day 28, Day 56

• Additional growth parameters: length

  Day 0, Day 28, Day 56

• Additional growth parameters: head circumference

  Day 0, Day 28, Day 56

Study Arms (3)

Experimental Group 1

EXPERIMENTAL

High dose probiotic supplement and maltodextrin as the excipient

Other: High dose probiotic supplement

Experimental Group 2

EXPERIMENTAL

Low dose probiotic supplement and maltodextrin as the excipient

Other: Low dose probiotic supplement

Control Group

PLACEBO COMPARATOR

Placebo supplement containing only maltodextrin but having the same appearance as the probiotic supplements

Other: Placebo

Interventions

High dose probiotic supplement OTHER

One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

Experimental Group 1

Low dose probiotic supplement OTHER

One probiotic stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

Experimental Group 2

Placebo OTHER

One placebo stick pack will be dissolved in 10 mL lukewarm formula milk or breastmilk at body temperature. The dissolved supplement will be fed orally, preferably in the morning, starting on Day 1 until Day 56.

Control Group

Eligibility Criteria

• Age: 14 Days - 21 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Infants whose parent(s)/LAR have reached the legal age of majority in the countries where the study is conducted.
• Infants whose parent(s)/LAR are willing and able to comply with scheduled visits, and the requirements of the study protocol.
• Infants whose parent(s)/LAR can be contacted directly by telephone throughout the study.
• Infants whose parent(s)/LAR have access to a working freezer.
• Healthy term (37-42 weeks of gestation) infant at birth.
• At enrolment visit, post-natal age 14-21 days (date of birth = day 0)
• Birth weight ≥ 2500g and ≤ 4500g.
• 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.
• 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.

You may not qualify if:

• Infants with conditions requiring specific infant feeding regimens other than those specified in the protocol.
• 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.
• 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:
• 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).
• History of admission to the Neonatal Intensive Care Unit (NICU), except for admission for jaundice phototherapy.
• 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.
• 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.
• Currently participating or having participated in another clinical trial since birth.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Asian Foundation for Tropical Medicine, Inc.

City of Muntinlupa, 1781, Philippines

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: February 23, 2021
• Study Start: February 26, 2021
• Primary Completion: August 23, 2021
• Study Completion: October 12, 2021
• Last Updated: March 24, 2023

Record last verified: 2023-03

Locations

PH (1)