Effect of a Specific Blend of Fibers and Probiotics on th... | NCT04424329

Studies
Effect of a Specific Blend of Fibers and Probiotics on the Microbiome

NCT04424329

Sponsor

Société des Produits Nestlé (SPN)

Status

Completed

Last Update Posted

Nov 13, 2020Actual

Enrollment

20Actual

Phase

Not Applicable

Conditions

Microbiota Perturbation by an Environmental Challenge

Interventions

Fibers and probiotics

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

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2, 2020Actual

Primary Completion Date

Sep 25, 2020Actual

Completion Date

Sep 25, 2020Actual

First Submitted Date

Jun 8, 2020

First Submission Date that Met QC Criteria

Jun 8, 2020

First Posted Date

Jun 9, 2020Actual

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

Nov 12, 2020

Last Update Posted Date

Nov 13, 2020Actual

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

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

20Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Nutrition intervention	Experimental	Ingestion of fibers and probiotics daily for 22 days	Dietary Supplement: Fibers and probiotics
No intervention	No Intervention	No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fibers and probiotics	Dietary Supplement	A blend of fibers and seven probiotics	Nutrition intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Minimizing microbiota composition change	Shotgum metagenomics	Daily from Day -4 to day + 7 (Day 0 is the start of the challenge)

Secondary Outcomes

Measure	Description	Time Frame
Increased intestinal microbiota diversity	Measured by the Shannon diversity index	Daily from Day -4 to day + 7 (Day 0 is the start of the dietary challenge)
Increased microbiota gene richness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent signed
Adult men and women aged 18 to 45 years
Healthy based on the medical screening visit and medical questionnaire
BMI in the range of 18.5 to 29.9 kg/m2.

Exclusion Criteria:

Known food allergy and intolerance
Currently participating in another clinical trial or research project
Fewer than 5 spontaneous bowel movements per week on average
Chronic or recurrent diarrhea with spontaneous bowel movements more often than 2 times daily
Systemic antibacterial/antifungal therapy during the 3 months prior to study enrolment
Medications or supplements that are known to alter gut function or microflora during the 4 weeks prior to study enrolment
Volunteers under anti-hyperlipidemic, antihypertensive, estrogen-related and/or anticoagulant agents
Prior gastrointestinal surgery (apart from appendectomy, cholecystectomy or herniotomy)
Alcohol intake higher than 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer.
Artificially sweetened beverage intake higher than 1000 ml/ per day
Female subjects will be excluded if they are pregnant, gave birth in the last 6 months, or are lactating.
Subject having a hierarchical or family link with the research team members.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Sami Damak	Société des produits Nestlé	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Société des produits Nestlé/Metabolic Unit		Lausanne		1000	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D019587	Dietary Supplements
D005502	Food
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena