Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides

NCT05555004 | Terminated

• 1 other identifier: 2113NR
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will compare the effect of test product #1 (containing a probiotic with the Galacto-OligoSaccharides fiber. GOS) and test product #2 (containing a probiotic without the GOS fiber) to understand how they can contribute to healthy digestion in toddlers between the age of 24 - 36 months. The hypothesis is that L. reuteri from TEST#1 will demonstrate an improved survival in the GIT of toddlers compared to that of TEST#2. This study is a single-centre, randomized, double-blind, comparator-controlled, parallel group study. The study will be conducted at the Clinical Innovation Lab (CIL) at Nestlé Research.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Colony forming units of feces (CFU/g)

  The primary end point is quantification of L. reuteri DSM 17938 in stool using quantitative polymerase chain reaction (qPCR).

  Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21

Secondary Outcomes (4)

• Gut microbiota

  Between Day 0 and Day 21

• Gastrointestinal (GI) tolerance and stooling patterns

  Between Day 0 and Day 21

• Assessment of dietary variety

  Between Day 0 and Day 21

• Safety and tolerability

  Between Day 0 and Day 21

Study Arms (2)

TEST1

EXPERIMENTAL

Other: TEST1

TEST2

EXPERIMENTAL

Other: TEST 2

Interventions

TEST1 OTHER

Toddler milk with preconditioned L. reuteri and containing GOS

TEST1

TEST 2 OTHER

Toddler milk with standard/non-preconditioned L. reuteri and not containing GOS.

TEST2

Eligibility Criteria

• Age: 24 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Child is between 24 months to 36 months of age.
• Singleton, full-term gestational birth (≥ 37 completed weeks of gestation), with a birth weight of ≥ 2.5 kg and ≤ 4.5 kg.
• Healthy status based on medical history and physical examination
• Weight- for-age and height-for-age within normal range on local childhood growth chart.
• Written informed consent are obtained from both parents/legally authorized representative (LAR).
• Parents/legally authorized representative must be able to provide evidence of the parental authority and identity.
• Parents /legally authorized representative are of legal age of consent and must understand the informed consent and other study documents.
• Parents/legally authorized representative are willing and able to fulfill the requirements of the study protocol.

You may not qualify if:

• Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
• Prior to study participation, child has shown limited or no interest in drinking toddler milk.
• Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
• Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
• Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
• Child is currently consuming or has consumed any formulas or taking any supplement containing GOS within the past 48 hrs prior to product in take, and who are not willing accept a temporary cessation of the consumption during the study period.
• Child is currently participating in another investigational clinical trial.
• Family or hierarchical relationships with the CIL team.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

Société des Produits Nestlé S.A.

Lausanne, Canton of Vaud, 1000, Switzerland

Location

Study Design

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

Model Details: comparator-controlled

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: September 26, 2022
• Study Start: June 30, 2022
• Primary Completion: April 6, 2023
• Study Completion: April 6, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CH (1)