Lower GI DiseaseNCT05041374
Evaluation of Patients With Gastrointestinal Disease
An observational study of Lower GI Disease and Gastrointestinal Diseases, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.
Trial summary
Background: Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lower GI Disease, Gastrointestinal Diseases
- How many people
- 4,000 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Jan 2022to 31 Dec 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with known or suspected gastrointestinal disease.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged >= 18 years of age
- Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Significant medical illnesses that the investigators feel may interfere with potential evaluations.
- Absence of a referring community physician who would be able to manage care outside of the NIH.
- 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.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Background:
Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future.
Read more
Objective:
To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.
Eligibility:
Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines.
Design:
Participants will be screened with a physical exam. Their medical records will be reviewed.
Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research.
Participants may give blood, urine, and/or stool samples.
If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use.
Data will be stored at NIH. The data systems are password protected. Samples will be coded.
Participants will take part in the study for as long as they agree to be seen for their disease....
Read the detailed description
Patients with suspected or established acute or chronic gastrointestinal diseases or who require clinical screening for gastrointestinal diseases are provided standard clinical care for their condition. Data and samples obtained during regular clinical care will be retained for future research in gastrointestinal diseases. Recommendations for other treatment options outside of the NIH will be discussed with study patients and may be discussed with their primary or referring physicians.
- Conditions
- Lower GI Disease, Gastrointestinal Diseases
- Keywords
- Digestive System Diseases, Gastrointestinal Diseases, Small Bowel Disease, Upper 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.
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases.
Development of a data set comprised of results and observations obtained during standard clinical care of patients with known or suspected gastrointestinal disease and collection of samples to be used for future research.
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start4 Jan 2022
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower GI DiseaseStudies 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
- 4,000 participants (estimated)
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
- NCT05041374
- Sponsor's protocol ID
- 10000247
- Other IDs
- 000247-DK
- Status last verified
- 2 Nov 2026
- First submitted
- 10 Sep 2021
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Patients With Gastrointestinal Disease
- ClinicalTrials.gov ID
- NCT05041374
- Acronym / sponsor ID
- 10000247
- Conditions
- Lower GI Disease, Gastrointestinal Diseases
- Keywords
- Digestive System Diseases, Gastrointestinal Diseases, Small Bowel Disease, Upper GI Disease, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
- Study start
- 4 Jan 2022 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 13 Sep 2021 (actual)
- 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:
Ongoing and future research projects that study gastrointestinal diseases depend on access to biological samples and clinical data. Researchers want to study people who are seen and treated for these diseases. This may help them assess and treat these diseases better in the future.
Objective:
To collect data and samples from people being seen and/or treated for gastrointestinal problems at NIH, to use in future research.
Eligibility:
Adults aged 18 and older who have known or suspected gastrointestinal disorders or need screening, treatment, or follow-up per current medical guidelines.
Design:
Participants will be screened with a physical exam. Their medical records will be reviewed.
Participants will be seen by doctors based on the ailment they have. Their condition will be treated just like it would at a doctor s office. But the data and samples collected will be used for future research.
Participants may give blood, urine, and/or stool samples.
If participants have an endoscopy or colonoscopy as part of their standard care and samples are taken, they may be asked to give their leftover samples to NIH. Or, they may be asked to have extra samples taken for NIH to use. These samples may include gastric acid and/or tissue from the lining of the stomach or intestines. If samples are not taken as part of their standard care, they may be asked to have samples taken for NIH to use.
Data will be stored at NIH. The data systems are password protected. Samples will be coded.
Participants will take part in the study for as long as they agree to be seen for their disease....
Detailed description
Patients with suspected or established acute or chronic gastrointestinal diseases or who require clinical screening for gastrointestinal diseases are provided standard clinical care for their condition. Data and samples obtained during regular clinical care will be retained for future research in gastrointestinal diseases. Recommendations for other treatment options outside of the NIH will be discussed with study patients and may be discussed with 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 to 120 years
- 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)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Male or female, aged >= 18 years of age
- Known or suspected gastrointestinal disorders or requiring clinical screening, management and/or treatment and follow-up per current American Gastroenterological Association (AGA), American Society for Gastrointestinal Endoscopy (ASGE) or the American Association for the Study of Liver Disease (AASLD).
Key exclusion criteria (5 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Significant medical illnesses that the investigators feel may interfere with potential evaluations.
- Absence of a referring community physician who would be able to manage care outside of the NIH.
- 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.
- Inability to provide informed consent.
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
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases.
Time frame: End of study
Development of a data set comprised of results and observations obtained during standard clinical care of patients with known or suspected gastrointestinal disease and collection of samples to be used for future research.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- 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.
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 Lower GI Disease and 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 5 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: looking for participants now, as of the sponsor's last update on 4 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gladys L Salas ((301) 594-0636, gladys.salas@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To collect data and samples during clinical evaluation, treatment and follow-up of participants for future use in studies of gastrointestinal diseases. (time frame: End of study). 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 4 Nov 2026.