Bacterially-synthesized Folate Absorption Across the Large Intestine

The Hospital for Sick Children

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: 13C6-p-aminobenzoic acid

Study type: Interventional

Funder types: Other

Identifiers

NCT02299778

1000026022

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

1mg of 13C6-p-aminobenzoic acid

Experimental group

Treatment:

Dietary Supplement: 13C6-p-aminobenzoic acid