Inflammatory Bowel DiseasesNCT04898530
Diet Patterns in IBD in Central Texas
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by University of Texas at Austin at 1 site in United States.
Trial summary
The purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with IBD in Central Texas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jun 2021to 31 Dec 2024
- 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
- Adult, Older adult
Study population: All patients with inflammatory bowel disease
Who may be able to join
- any patient 18years of age or older with inflammatory bowel disease
Who cannot join
- unwilling to participate
- diagnosis of IBD unable to be verified
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cross-sectional Assessment of Diet in Patients With IBD in Central Texas
The purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with IBD in Central Texas.
- Being tested
- NO INTERVENTION
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NO INTERVENTIONOther
There is no intervention for this study.
What is being measured
The primary outcome is the main question the study is designed to answer.
diet patterns
diet descriptions, ASA24
Measured: 6 months
diet preferences
via questionnaires
Measured: 6 months
diet impact
various outcomes
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start8 Jun 2021
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: interim analyses undeway
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- More trials run by University of Texas at AustinThe 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Texas at Austin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Linda Anne Feagins, MD, University of Texas at Austin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898530
- Sponsor's protocol ID
- STUDY00000439
- Status last verified
- May 2024
- First submitted
- 13 May 2021
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Assessment of Diet in Patients With IBD in Central Texas
- ClinicalTrials.gov ID
- NCT04898530
- Acronym / sponsor ID
- STUDY00000439
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: interim analyses undeway
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University of Texas at AustinUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 24 May 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.
The purpose of the study is to understand the diet patterns, preferences, and impact of diet on daily living in our patients with IBD in Central Texas.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients with inflammatory bowel disease
Key inclusion criteria (1 listed)
- any patient 18years of age or older with inflammatory bowel disease
Key exclusion criteria (2 listed)
- unwilling to participate
- diagnosis of IBD unable to be verified
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 |
|---|---|---|
| NO INTERVENTIONThere is no intervention for this study. | Other | – |
Primary outcome
diet patterns
Time frame: 6 months
diet descriptions, ASA24
diet preferences
Time frame: 6 months
via questionnaires
diet impact
Time frame: 6 months
various outcomes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Inflammatory Bowel Diseases and Crohn Disease, run by University of Texas at Austin 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 1 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: paused, as of the sponsor's last update on 8 May 2024. 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?
Results are not available in the source record.
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?
diet patterns (time frame: 6 months). The study lists 3 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 8 May 2024; AzTrials last refreshed its copy on 4 Nov 2026.