Bacterially-synthesized Folate Absorption Across the Large Intestine

Healthy Clinical Trial

Official title:

Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02299778
• Other study ID #: 1000026022
• Status: Completed
• Phase: Phase 1
• First received: October 23, 2014
• Last updated: October 14, 2015
• Start date: April 2014
• Est. completion date: April 2015

Study information

• Verified date: October 2015
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Bio-availability Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• 13C6-p-aminobenzoic acid

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	No
Primary	Change in isotopic folate overtime in urine		Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)	No
Secondary	Folate intake	Assessed using food records	Day1-4	No
Secondary	Fiber intake	Assessed using food records	Day1-4	No