Gastrointestinal DiseasesNCT01639924
Evaluation of People With Gastrointestinal Disease
An observational study of Gastrointestinal Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Diseases
- How many people
- 2,761 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2012to 15 Feb 2022
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected gastrointestinal disease.@@@@@@
Who may be able to join
- Known or suspected gastrointestinal disorders.
- Patients greater than or equal to 18 years of age capable of providing informed consent.
- Existence of a referring community physician who would be able to manage care outside of the NIH.
Who cannot join
- Significant medical illnesses that the investigators feel may interfere with potential evaluations.
- Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Evaluation of Patients With Gastrointestinal Disease
Background:
- Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. People who are interested in clinical trials need to be screened before they can take part in the studies. Researchers want to evaluate people with different stomach and intestine disorders to see if they are eligible for clinical trials.
Read more
Objectives:
- To study people who have gastrointestinal disorders and see if they are eligible for clinical trials.
Eligibility:
- Individuals at least 18 years of age who have or may have a gastrointestinal disorder.
Design:
- Participants will be screened with a physical exam and medical history. Blood, urine, and stool samples will be collected. Imaging studies such as x-rays and ultrasound will check to see if the disorder has affected other organs.
- Participants may have tests as needed depending on their disorder. These tests include the following:
- Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.
- Stomach acid analysis to look at stomach pH levels.
- Wireless capsule endoscopy to take pictures of the small intestine.
- Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.
- Sitz Marker Study to see how fast stool moves through the colon.
- Participants may donate extra blood, urine, or stool samples for study. They may also donate stomach contents or tissue from the gut.
- Treatment will not be provided as part of this study. However, participants may be admitted to other clinical trials.
Read the detailed description
Patients with suspected or established acute or chronic gastrointestinal diseases are evaluated and treated in this protocol and will be screened for entry into other research protocols. This protocol serves several purposes: 1) allows for detailed inquiry into the gastrointestinal disorders of these patients and the status of other organ systems that would determine their ability to safely enroll in active Digestive Diseases Branch (DDB) research protocols; 2) allows investigators to offer clinical diagnostic testing, procedures, and treatment to patients if clinically indicated to facilitate their participation in clinical trials; 3) allows outpatient evaluation and treatment of patients with a variety of gastrointestinal diseases for the purposes of physician education in our accredited gastroenterology training program; and 4) After completion of the initial evaluation process, patients will either be offered a chance to participate in an active research protocol or, if no appropriate protocol is identified, patients may be seen long-term to follow the disease progression for potential future participation in DDB gastrointestinal studies. Recommendations for other treatment options outside of the NIH will be discussed with study patients and/or to their primary or referring physicians.
- Conditions
- Gastrointestinal Diseases
- Keywords
- Upper GI Disease, Small Bowel Disease, Digestive Disease, Gastrointestinal Disease, Lower GI Disease, Natural History
- Medical subject headings
- Gastrointestinal Diseases, Digestive System Diseases
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 |
|---|---|---|
| Study Cohort | Patients with known or suspected gastrointestinal disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients with gastrointestinal disease
screening protocol for gastrointestinal diseases.
Measured: until protocol closes
Secondary outcomes (1)
Allow outpatient evaluation and follow-up of patients with a variety of gastrointestinal diseases for the purposes of physician education in the NIDDK's accredited gastroenterology training program.
evaluation and follow-up of gastrointestinal diseases.
Measured: until protocol closes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2012 (estimated)
- Study start27 Jul 2012
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,761 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Sheila Kumar, M.D., Principal investigator, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01639924
- Sponsor's protocol ID
- 120154
- Other IDs
- 12-DK-0154
- Status last verified
- Feb 2022
- First submitted
- 11 Jul 2012
- Last updated
- 18 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT01639924
- Acronym / sponsor ID
- 120154
- Conditions
- Gastrointestinal Diseases
- Keywords
- Upper GI Disease, Small Bowel Disease, Digestive Disease, Gastrointestinal Disease, Lower GI Disease, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,761 participants (actual)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 27 Jul 2012 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 13 Jul 2012 (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.
Background:
- Gastrointestinal diseases and disorders affect the throat, stomach, and intestines. There are many different kinds of these diseases. Clinical trials are being developed to study new ways to treat them. People who are interested in clinical trials need to be screened before they can take part in the studies. Researchers want to evaluate people with different stomach and intestine disorders to see if they are eligible for clinical trials.
Objectives:
- To study people who have gastrointestinal disorders and see if they are eligible for clinical trials.
Eligibility:
- Individuals at least 18 years of age who have or may have a gastrointestinal disorder.
Design:
- Participants will be screened with a physical exam and medical history. Blood, urine, and stool samples will be collected. Imaging studies such as x-rays and ultrasound will check to see if the disorder has affected other organs.
- Participants may have tests as needed depending on their disorder. These tests include the following:
- Colonoscopy and endoscopy of the large intestine, esophagus, and stomach.
- Stomach acid analysis to look at stomach pH levels.
- Wireless capsule endoscopy to take pictures of the small intestine.
- Hydrogen breath testing to study issues like bloating, diarrhea, and constipation.
- Sitz Marker Study to see how fast stool moves through the colon.
- Participants may donate extra blood, urine, or stool samples for study. They may also donate stomach contents or tissue from the gut.
- Treatment will not be provided as part of this study. However, participants may be admitted to other clinical trials.
Detailed description
Patients with suspected or established acute or chronic gastrointestinal diseases are evaluated and treated in this protocol and will be screened for entry into other research protocols. This protocol serves several purposes: 1) allows for detailed inquiry into the gastrointestinal disorders of these patients and the status of other organ systems that would determine their ability to safely enroll in active Digestive Diseases Branch (DDB) research protocols; 2) allows investigators to offer clinical diagnostic testing, procedures, and treatment to patients if clinically indicated to facilitate their participation in clinical trials; 3) allows outpatient evaluation and treatment of patients with a variety of gastrointestinal diseases for the purposes of physician education in our accredited gastroenterology training program; and 4) After completion of the initial evaluation process, patients will either be offered a chance to participate in an active research protocol or, if no appropriate protocol is identified, patients may be seen long-term to follow the disease progression for potential future participation in DDB gastrointestinal studies. Recommendations for other treatment options outside of the NIH will be discussed with study patients and/or to their primary or referring physicians.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Cohort | – | –Patients with known or suspected gastrointestinal disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known or suspected gastrointestinal disease.@@@@@@
Key inclusion criteria (3 listed)
- Known or suspected gastrointestinal disorders.
- Patients greater than or equal to 18 years of age capable of providing informed consent.
- Existence of a referring community physician who would be able to manage care outside of the NIH.
Key exclusion criteria (2 listed)
- Significant medical illnesses that the investigators feel may interfere with potential evaluations.
- Any medical, psychiatric, or social conditions which, in the opinion of the investigators, would make participation in this protocol not in the best interest of the patient.
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
Patients with gastrointestinal disease
Time frame: until protocol closes
screening protocol for gastrointestinal diseases.
1 secondary outcome
Allow outpatient evaluation and follow-up of patients with a variety of gastrointestinal diseases for the purposes of physician education in the NIDDK's accredited gastroenterology training program.
Time frame: until protocol closes
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 18 Feb 2022.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Sheila Kumar, M.D. principal investigator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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 Gastrointestinal Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) 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 18 Feb 2022. 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?
Patients with gastrointestinal disease (time frame: until protocol closes). 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 18 Feb 2022.