Growth, Safety and Efficacy of a Probiotic Supplement

NCT ID: NCT04765852

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-26
• Study Completion Date: 2021-10-12

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.

Conditions

Probiotic Supplement

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Experimental Group 1

High dose probiotic supplement and maltodextrin as the excipient

Group Type: EXPERIMENTAL

High dose probiotic supplement

Intervention Type: 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

Low dose probiotic supplement and maltodextrin as the excipient

Group Type: EXPERIMENTAL

Low dose probiotic supplement

Intervention Type: 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.

Control Group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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.

Interventions

High dose probiotic supplement

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.

Intervention Type: OTHER

Low dose probiotic supplement

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.

Intervention Type: OTHER

Placebo

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.

Intervention Type: OTHER

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.

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.

• Minimum Eligible Age: 14 Days
• Maximum Eligible Age: 21 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Société des Produits Nestlé (SPN)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Asian Foundation for Tropical Medicine, Inc.

City of Muntinlupa, , Philippines

Countries

Philippines

Other Identifiers

20.11.INF

Identifier Type: -

Identifier Source: org_study_id