Bacterially-synthesized Folate Absorption Across the Large Intestine

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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1mg of 13C6-p-aminobenzoic acid

Group Type EXPERIMENTAL

13C6-p-aminobenzoic acid

Intervention Type DIETARY_SUPPLEMENT

Interventions

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13C6-p-aminobenzoic acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes