HealthyPhase 1NCT02299778
Bacterially-synthesized Folate Absorption Across the Large Intestine
A Phase 1 study testing 13C6-p-aminobenzoic acid in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 13C6-p-aminobenzoic acid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2014to Apr 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-65 years;
- overall healthy
Who cannot join
- <18 years or >65 years
- chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- 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])
- consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
- planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
- known sensitivity to sunscreens containing ultraviolet B filters and/or PABA
- difficulty with swallowing large pills or providing venous blood samples
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?
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.
- Conditions
- Healthy
- Being tested
- 13C6-p-aminobenzoic acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
13C6-p-aminobenzoic acidDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 1mg of 13C6-p-aminobenzoic acid | Experimental | Not described Receives: Dietary Supplement: 13C6-p-aminobenzoic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in isotopic folate overtime in blood
Measured: 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
Measured: Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)
Secondary outcomes (2)
Folate intake
Assessed using food records
Measured: Day1-4
Fiber intake
Assessed using food records
Measured: Day1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah O'Connor, The Hospital for Sick Children
- Investigators
- Deborah L O'Connor, RD, PhD, Principal investigator, The Hospital for Sick Children, Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02299778
- Sponsor's protocol ID
- 1000026022
- Status last verified
- Oct 2015
- First submitted
- 23 Oct 2014
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is Bacterially-Synthesized Folate Absorbed Across the Colon of Humans?
- ClinicalTrials.gov ID
- NCT02299778
- Acronym / sponsor ID
- 1000026022
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1mg of 13C6-p-aminobenzoic acid | Experimental | Dietary Supplement: 13C6-p-aminobenzoic acid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 18-65 years;
- overall healthy
Key exclusion criteria (7 listed)
- <18 years or >65 years
- chronic disease (eg. history of hepatic, gastrointestinal, renal, vascular, haematological or neuropsychiatric disease) or surgery affecting gastrointestinal motility, pH or folate absorption/metabolism
- 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])
- consumption of >1 drink/day of alcohol on a regular basis or current smoking (last 6 months)
- planning a pregnancy, pregnant, breast feeding or the use of high-dose estrogen oral contraceptives/hormone replacement therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 13C6-p-aminobenzoic acid | Dietary supplement | 1mg of 13C6-p-aminobenzoic acid |
Primary outcome
Change in isotopic folate overtime in blood
Time frame: 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
Time frame: Day 1 (0-24hr), Day 2 (25-48hr), Day 3 ( 49-72hr), Day 4 (73-96hr)
2 secondary outcomes
Folate intake
Time frame: Day1-4
Fiber intake
Time frame: Day1-4
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah L O'Connor, RD, PhD principal investigator
The Hospital for Sick Children, Toronto, ON, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 13C6-p-aminobenzoic acid in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in isotopic folate overtime in blood (time frame: Baseline (day 1), Days 2-4 ( 0h,1h,2h,3h,4h,5h,6h,7h,8h,9h,10h,11h,12h,24hr,48hr)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2015.