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

Sponsor
Nestlé (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05555004
Collaborator
(none)
82
1
2
8
10.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: TEST1
  • Other: TEST 2
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
82 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
comparator-controlledcomparator-controlled
Masking:
Double (Participant, Investigator)
Masking Description:
Double-blind
Primary Purpose:
Prevention
Official Title:
Evaluation of Probiotic (L.Reuteri) Survival in Presence of Prebiotic Galacto-oligosaccharides (GOS)
Actual Study Start Date :
Jun 30, 2022
Anticipated Primary Completion Date :
Mar 1, 2023
Anticipated Study Completion Date :
Mar 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: TEST1

Other: TEST1
Toddler milk with preconditioned L. reuteri and containing GOS

Experimental: TEST2

Other: TEST 2
Toddler milk with standard/non-preconditioned L. reuteri and not containing GOS.

Outcome Measures

Primary Outcome Measures

  1. Colony forming units of feces (CFU/g) [Baseline (visit Day 0), Day 2, Day 3, Day4, Day 5, Day6 Day 7 and D21]

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

Secondary Outcome Measures

  1. Gut microbiota [Between Day 0 and Day 21]

    Diversity and functionality will be evaluated on at least 8 stools samples using shotgun metagenomic sequencing. Structure and prevalence of microbiota and evaluation of taxa and function in the survival of the probiotic.

  2. Gastrointestinal (GI) tolerance and stooling patterns [Between Day 0 and Day 21]

    Parent perceptions of GI symptoms and GI-related behaviors using Toddler Gut Comfort Questionnaire (GCQ) and stool frequency and consistency

  3. Assessment of dietary variety [Between Day 0 and Day 21]

    Dietary variety assessed using a parent-reported Food Frequency Questionnaire (FFQ)

  4. Safety and tolerability [Between Day 0 and Day 21]

    - Adverse events type, incidence, severity, and relationship to TEST1 and TEST2 products.

Eligibility Criteria

Criteria

Ages Eligible for Study:
24 Months to 36 Months
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Société des Produits Nestlé S.A. Lausanne Vaud Switzerland 1000

Sponsors and Collaborators

  • Nestlé

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Nestlé
ClinicalTrials.gov Identifier:
NCT05555004
Other Study ID Numbers:
  • 2113NR
First Posted:
Sep 26, 2022
Last Update Posted:
Sep 26, 2022
Last Verified:
Sep 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 26, 2022