Evaluation of Probiotic (L.Reuteri) Survival in Presence... | NCT05555004

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

NCT05555004

Sponsor

Société des Produits Nestlé (SPN)

Status

Terminated

Last Update Posted

May 6, 2023Actual

Enrollment

25Actual

Phase

Not Applicable

Conditions

Healthy

Interventions

TEST1
TEST 2

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Based on slow recruitement and Interim analysis recommendation, the core team decide to stop the study

Expanded Access Info

Start Date

Jun 30, 2022Actual

Primary Completion Date

Apr 6, 2023Actual

Completion Date

Apr 6, 2023Actual

First Submitted Date

Jul 14, 2022

First Submission Date that Met QC Criteria

Sep 22, 2022

First Posted Date

Sep 26, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2023

Last Update Posted Date

May 6, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

25Actual

Label	Type	Description	Intervention Names
TEST1	Experimental		Other: TEST1
TEST2	Experimental		Other: TEST 2

Name	Type	Description	Arm Group Labels	Other Names
TEST1	Other	Toddler milk with preconditioned L. reuteri and containing GOS	TEST1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Gut microbiota	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.	Between Day 0 and Day 21
Gastrointestinal (GI) tolerance and stooling patterns

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Months

Maximum Age

36 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided