Clinical trial NCT05555004: Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides
Official title: Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Healthy
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2022-09-26
Enrollment: 25
Sex: ALL
Minimum age (years): 24
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: comparator-controlled
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Known or suspected cows' milk protein intolerance / allergy, or lactose intolerance, or significant food allergies that impact a normal diet.
2. Prior to study participation, child has shown limited or no interest in drinking toddler milk.
3. Chronic infectious, gastrointestinal, metabolic, or genetic disease, including any disease/condition that impacts feeding or growth.
4. Use of systemic antibiotics or anti-mycotic medication in the 4 weeks preceding enrollment.
5. Child is currently consuming or has consumed any formulas or taking any supplement containing L. reuteri in the past 3 months.
6. 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.
7. Child is currently participating in another investigational clinical trial.
8. Family or hierarchical relationships with the CIL team.

Primary outcomes:
measure: Colony forming units of feces (CFU/g)
timeFrame: Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21
Secondary outcomes:
measure: Gut microbiota
timeFrame: Between Day 0 and Day 21
measure: Gastrointestinal (GI) tolerance and stooling patterns
timeFrame: Between Day 0 and Day 21
measure: Assessment of dietary variety
timeFrame: Between Day 0 and Day 21
measure: Safety and tolerability
timeFrame: Between Day 0 and Day 21
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Société des Produits Nestlé S.A.
state: Vaud
Study officials:
References: