Human Gut Microbiota and Prebiotic Response | NCT03595306

Studies
Human Gut Microbiota and Prebiotic Response

NCT03595306

Sponsor

Duke University

Status

Completed

Last Update Posted

Jun 3, 2019Actual

Enrollment

41Actual

Phase

Not Applicable

Conditions

Healthy Gut Microbiota

Interventions

Prebiotic A - inulin
Prebiotic B - galactooligosaccharides(GOS)
Prebiotic C - wheat dextrin

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

May 2019

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

May 1, 2018Actual

Primary Completion Date

May 19, 2019Actual

Completion Date

May 19, 2019Actual

First Submitted Date

Jul 11, 2018

First Submission Date that Met QC Criteria

Jul 11, 2018

First Posted Date

Jul 23, 2018Actual

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 31, 2019

Last Update Posted Date

Jun 3, 2019Actual

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 study is designed to examine the shift in gut microbiota and their metabolism after consumption of a dietary supplement (prebiotic) by healthy participants. The investigators will provide participants with a panel of over the counter prebiotics and monitor their gut microbiome response in stool. All prebiotics will be commercially available, over-the-counter food, food additives, or dietary supplements, without any known market-use adverse effects beyond minimal discomfort.

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

41Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Prebiotic A	Experimental	Dietary Supplement: Prebiotic A - inulin Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS) Dietary Supplement: Prebiotic C - wheat dextrin
Prebiotic B	Experimental	Dietary Supplement: Prebiotic A - inulin Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS) Dietary Supplement: Prebiotic C - wheat dextrin
Prebiotic C	Experimental	Dietary Supplement: Prebiotic A - inulin Dietary Supplement: Prebiotic B - galactooligosaccharides(GOS) Dietary Supplement: Prebiotic C - wheat dextrin

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Prebiotic A - inulin	Dietary Supplement	Pre-weighed packages will be given twice daily for 5 days.	Prebiotic A Prebiotic B Prebiotic C

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in levels of SCFAs in stool samples		Baseline and 6 weeks

Secondary Outcomes

Measure	Description	Time Frame
change in levels of cytokines in stool samples		Baseline and 6 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Provide Stool Samples at no risk to yourself

Exclusion Criteria:

No oral antibiotic treatments within previous 1 month
No known allergy to milk products or lactose intolerance
no known allergy to wheat or gluten intolerance
no history of irritable bowel syndrome
no history of inflammatory bowel disease
no history of type-2 diabetes
no history of chronic kidney disease or reduced kidney function
no current intestinal obstructions
no current untreated colorectal cancer
not currently pregnant or breastfeeding

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

70 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lawrence David	Duke University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University		Durham	North Carolina	27708	United States