Ulcerative ColitisNCT01091558
Study of Effects of L-Arginine in Colitis and Colon Cancer
An observational study of Ulcerative Colitis and Colon Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell. The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis, Colon Cancer
- How many people
- 204 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Dec 2011
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.
Who may be able to join
- 18 years of age or older
- Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
- Screening for cancer
Who cannot join
- refusal to participate
- age less than 18 years at time of colonoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer
The purpose of this study is to look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.
The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.
Read the detailed description
Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.
- Conditions
- Ulcerative Colitis, Colon Cancer
- Keywords
- ulcerative colitis, colon cancer, endoscopy, screening
- Medical subject headings
- Colitis, Ulcerative, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Colonoscopy | Healthy volunteer who is having a screening colonoscopy | |
| Ulcerative Colitis | Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons. |
What is being measured
The primary outcome is the main question the study is designed to answer.
L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity
Measured: 24 months
Secondary outcomes (1)
L-Arg intake in the diet of UC patients and control subjects
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Keith Wilson, Vanderbilt University Medical Center
- Investigators
- Keith Wilson, MD, AGAF, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091558
- Sponsor's protocol ID
- 090943
- Other IDs
- 3R01AT004821-02S1
- Status last verified
- Mar 2017
- First submitted
- 18 Mar 2010
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gobert AP, Latour YL, Asim M, Barry DP, Allaman MM, Finley JL, Smith TM, McNamara KM, Singh K, Sierra JC, Delgado AG, Luis PB, Schneider C, Washington MK, Piazuelo MB, Zhao S, Coburn LA, Wilson KT. Protective Role of Spermidine in Colitis and Colon Carcinogenesis. Gastroenterology. 2022 Mar;162(3):813-827.e8. doi: 10.1053/j.gastro.2021.11.005. Epub 2021 Nov 10.
PubMed 34767785
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunomodulary Effects of Arginine Supplementation in Colitis and Colon Cancer
- ClinicalTrials.gov ID
- NCT01091558
- Acronym / sponsor ID
- 090943
- Conditions
- Ulcerative Colitis, Colon Cancer
- Keywords
- ulcerative colitis, colon cancer, endoscopy, screening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 24 Mar 2010 (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 look at the importance of L-Arginine in the digestive tract. L-Arginine is an amino acid and is important in making proteins within the cell.
The evaluation of colon tissue, blood, urine, diet, health history, and symptoms will help us learn more about L-Arginine and ulcerative colitis. The investigators believe these studies will provide new insights into the treatment for Inflammatory Bowel Disease (ulcerative colitis) and nutritional needs. The investigators plan to enroll 200 participants in this study over the next two years.
Detailed description
Amino acids are being measured in colon tissues and in serum by high performance liquid chromotography (HPLC). Cytokines and chemokines are being measured in colon tissues and in serum by Luminex assay. Cytokines and chemokines are also being measured in colon tissues by real-time polymerase chain reaction (PCR) analysis of mRNA expression.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colonoscopy | – | –Healthy volunteer who is having a screening colonoscopy |
| Ulcerative Colitis | – | –Patients with confirmed ulcerative colitis who are scheduled for endoscopy for medical reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any patient scheduled to have a colonoscopy as part of medical care for either ulcerative colitis or as a routine screening colonoscopy.
Key inclusion criteria (3 listed)
- 18 years of age or older
- Colonoscopy for one of the following: clinical indications, disease assessment, or surveillance for dysplasia (as in ulcerative colitis)
- Screening for cancer
Key exclusion criteria (2 listed)
- refusal to participate
- age less than 18 years at time of colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity
Time frame: 24 months
1 secondary outcome
L-Arg intake in the diet of UC patients and control subjects
Time frame: 24 months
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 31 Mar 2017.
- Derived from this study: PubMed 34767785Gobert AP, Latour YL, Asim M, Barry DP, Allaman MM, Finley JL, Smith TM, McNamara KM, Singh K, Sierra JC, Delgado AG, Luis PB, Schneider C, Washington MK, Piazuelo MB, Zhao S, Coburn LA, Wilson KT. Protective Role of Spermidine in Colitis and Colon Carcinogenesis. Gastroenterology. 2022 Mar;162(3):813-827.e8. doi: 10.1053/j.gastro.2021.11.005. Epub 2021 Nov 10.
- Individual participant dataSharing planned: No
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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.
Keith Wilson, MD, AGAF principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis and Colon Cancer, run by Vanderbilt University Medical Center at 1 site in United States.
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 3 inclusion and 2 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 31 Mar 2017. 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 United States. 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.
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?
L-Arginine (L-Arg) availability in ulcerative colitis (UC) patients and normal control subjects, and correlate with disease activity (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091558, which also lists 1 linked publication.
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 31 Mar 2017.