Bacterially-synthesized Folate Absorption Across the Larg... | NCT02299778

Studies
Bacterially-synthesized Folate Absorption Across the Large Intestine

NCT02299778

Sponsor

The Hospital for Sick Children

Status

Completed

Last Update Posted

Oct 16, 2015Estimated

Enrollment

10Estimated

Phase

Phase 1

Conditions

Healthy

Interventions

13C6-p-aminobenzoic acid

Countries

Canada

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

Oct 2015

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

Apr 2014

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Oct 23, 2014

First Submission Date that Met QC Criteria

Nov 20, 2014

First Posted Date

Nov 24, 2014Estimated

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

Oct 14, 2015

Last Update Posted Date

Oct 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 purpose of this study is to determine whether folate produced by bacteria that live in our colon can be absorbed in human colon using a stable isotope method. This study would lead a better understanding of the bioavailability of colonic bacterially-synthesized folate and its quantitative contribution to whole body folate homeostasis.

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

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
1mg of 13C6-p-aminobenzoic acid	Experimental		Dietary Supplement: 13C6-p-aminobenzoic acid

Name	Type	Description	Arm Group Labels	Other Names
13C6-p-aminobenzoic acid	Dietary Supplement		1mg of 13C6-p-aminobenzoic acid

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in isotopic folate overtime in blood		Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)
Change in isotopic folate overtime in urine		Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)

Secondary Outcomes

Measure	Description	Time Frame
Folate intake	Assessed using food records	Day1-4
Fiber intake	Assessed using food records	Day1-4

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18-65 years;
overall healthy

Exclusion Criteria:

<18 years or >65 years
chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
regular use of medications affecting gastrointestinal pH, motility or folate absorption/metabolism (eg. antiacids, laxatives, phenytoin, sulfasalzine, phenobarbital, primidone, cimetidine, proton pump inhibitors [such as Nexium] and antibiotics [such as Sulfonamides] or nonsteroidal anti-inflammatory drugs [NSAIDS, such as aspirin/ibuprofen])
consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
difficulty with swallowing large pills or providing venous blood samples

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deborah L O'Connor, RD, PhD	The Hospital for Sick Children, Toronto, ON, Canada	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Hospital for Sick Children		Toronto	Ontario	M5G 1X8	Canada