Bacterially-synthesized Folate Absorption Across the Large Intestine

Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: 13C6-p-aminobenzoic acid

• Registration Number: NCT02299778
• Lead Sponsor: The Hospital for Sick Children

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 available

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-10-23
• Study First Submitted QC: 2014-11-20
• Study First Posted: 2014-11-24
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-14
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. 18-65 years;
2. overall healthy

Exclusion Criteria

1. <18 years or >65 years
2. chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
3. 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])
4. consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
5. planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
6. known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
7. difficulty with swallowing large pills or providing venous blood samples

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1mg of 13C6-p-aminobenzoic acid	13C6-p-aminobenzoic acid	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Folate intake	Day1-4	Assessed using food records
Fiber intake	Day1-4	Assessed using food records

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada