Detection of Gut Metabolites in Mother's Milk Following J... | NCT04596254

Studies
Detection of Gut Metabolites in Mother's Milk Following Juice Intake

NCT04596254

Sponsor

Amazentis SA

Status

Completed

Last Update Posted

Jun 22, 2023Actual

Enrollment

7Actual

Phase

Not Applicable

Conditions

Healthy Diet

Interventions

Pomegranate Juice

Countries

United States

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

Jun 2023

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

Oct 15, 2020Actual

Primary Completion Date

Dec 31, 2022Actual

Completion Date

Dec 31, 2022Actual

First Submitted Date

Oct 15, 2020

First Submission Date that Met QC Criteria

Oct 15, 2020

First Posted Date

Oct 22, 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

Jun 20, 2023

Last Update Posted Date

Jun 22, 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

The goal of the biological sample collection is to assess the presence of gut metabolites in human breast milk (BM) samples obtained prospectively from healthy lactating mothers and after consumption of fruit juice.

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

7Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Juice Intake	Other		Other: Pomegranate Juice

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pomegranate Juice	Other	Collection of Mother's milk before and after juice consumption	Juice Intake

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in levels of gut metabolites in breast milk following juice intake	Collection before and after juice intake	7 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

20-40 yrs. female subjects with no lactation problems
Healthy and term delivery
Healthy dietary intake (vegetarian or omnivore)
Agree to donate breast milk (not colostrum)
First 6 months of lactation
Subjects agree to consumer 8oz. of pomegranate juice for a week prior to 2nd collection

Exclusion Criteria:

<20 yrs or >40 yrs. of age
Subjects with lactation problems
Preterm delivery
Colostrum samples
Lactation>6 months
Subjects fail to drink juice for at least a week

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Anurag SIngh, MD, PhD	Amazentis SA	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Valleywise Health Biobank		Phoenix	Arizona	85008	United States

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