Diet in Ulcerative Colitis PatientsNCT04332328
Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt
An observational study of Diet in Ulcerative Colitis Patients, run by Assiut University.
Trial summary
Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Diet in Ulcerative Colitis Patients
- What is being tested?
- Diet
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2020to 30 Apr 2021
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Patients with ulcerative colitis with no other comorbidities
Who may be able to join
- patients with ulcerative colitis diagnosed by clinical Endoscopic and histopathological methods
Who cannot join
- -
- Patients with any co morbidity ( HTN,DM,Primary sclerosing cholangitis, as those patients need some restrictions of diet which may affect the prognosis of the disease)
About this study
Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to UC patients(Haskkey,N et al 2017).
- Conditions
- Diet in Ulcerative Colitis Patients
- Being tested
- Diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietDietary supplement
Group of diet types
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative patients | Not described Receives: Dietary Supplement: Diet | |
| Non ulcerative patients | Not described Receives: Dietary Supplement: Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt
Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt
Measured: A year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start1 Apr 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diet in Ulcerative Colitis PatientsStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Snaa Mohammed Sayed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04332328
- Sponsor's protocol ID
- 3032020
- Status last verified
- Mar 2020
- First submitted
- 31 Mar 2020
- Last updated
- 2 Apr 2020
- 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 2 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt
- ClinicalTrials.gov ID
- NCT04332328
- Acronym / sponsor ID
- 3032020
- Conditions
- Diet in Ulcerative Colitis Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 2 Apr 2020 (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.
Diet is known to play role in the complex etiology of UC.Patient with UC tend to adapt unguided dietary habits without the guidance of a dietician or physician (Dejong,M.J 2019).so identification of nutritional gaps is needed to facilitate the development of evidence-based dietary guideline and subsequently give correct dietary advice to UC patients(Haskkey,N et al 2017).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative patients | – | Dietary Supplement: Diet |
| Non ulcerative patients | – | Dietary Supplement: Diet |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with ulcerative colitis with no other comorbidities
Key inclusion criteria (1 listed)
- patients with ulcerative colitis diagnosed by clinical Endoscopic and histopathological methods
Key exclusion criteria (2 listed)
- -
- Patients with any co morbidity ( HTN,DM,Primary sclerosing cholangitis, as those patients need some restrictions of diet which may affect the prognosis of the disease)
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 |
|---|---|---|
| DietGroup of diet types | Dietary supplement | Non ulcerative patients, Ulcerative patients |
Primary outcome
Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt
Time frame: A year
Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Diet in Ulcerative Colitis Patients, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Study of demographic and dietary profile in patients with ulcerative colitis in upper Egypt (time frame: A year). 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 2 Apr 2020.