Growth, Safety and Efficacy of a Probiotic Supplement

Growth, Safety and Efficacy of a Probiotic Supplement: a Double-blind, Randomized, Placebo-controlled Trial

Patrocinadores

Patrocinador principal: Nestlé

Fuente Nestlé
Resumen breve

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

Descripción detallada

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.

Estado general Not yet recruiting
Fecha de inicio February 28, 2021
Fecha de Terminación November 2021
Fecha de finalización primaria September 2021
Fase N/A
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Safety of high dose probiotic supplement (weight gain) Day 56
Resultado secundario
Medida Periodo de tiempo
Efficacy of two different doses of probiotic supplement Day 0, Day 25-27, Day 53-55
Inscripción 228
Condición
Intervención

Tipo de intervención: Other

Nombre de intervención: High dose probiotic supplement

Descripción: 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.

Etiqueta de grupo de brazo: Experimental Group 1

Tipo de intervención: Other

Nombre de intervención: Low dose probiotic supplement

Descripción: 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.

Etiqueta de grupo de brazo: Experimental Group 2

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: 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.

Etiqueta de grupo de brazo: Control Group

Elegibilidad

Criterios:

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.

Género: All

Edad mínima: N/A

Edad máxima: 21 Days

Voluntarios Saludables: Accepts Healthy Volunteers

Contacto general

Apellido: Maria Rosario Z. Capeding, MD

Teléfono: +63227719233

Email: [email protected]

Ubicación
Instalaciones: Contacto: Investigador: Asian Foundation for Tropical Medicine, Inc. Maria Rosario Z. Capeding, MD +63917 850 9788 [email protected] Maria Rosario Z. Capeding, MD Principal Investigator
Ubicacion Paises

Philippines

Fecha de verificación

February 2021

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 3
Grupo de brazo

Etiqueta: Experimental Group 1

Tipo: Experimental

Descripción: High dose probiotic supplement and maltodextrin as the excipient

Etiqueta: Experimental Group 2

Tipo: Experimental

Descripción: Low dose probiotic supplement and maltodextrin as the excipient

Etiqueta: Control Group

Tipo: Placebo Comparator

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

Acrónimo Clara
Datos del paciente Undecided
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Other

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov