Bacterially-synthesized Folate Absorption Across the Large Intestine

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02299778

Enrollment

Registered

2014-11-24

Start date

2014-04-30

Completion date

2015-04-30

Last updated

2015-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy

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.

Interventions

DIETARY_SUPPLEMENT13C6-p-aminobenzoic acid

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026