Study of Demographic and Dietary Profile in Patients With... | NCT04332328

Studies
Study of Demographic and Dietary Profile in Patients With Ulcerative Colitis in Upper Egypt

NCT04332328

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Apr 2, 2020Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Diet in Ulcerative Colitis Patients

Interventions

Diet

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1, 2020Estimated

Primary Completion Date

Nov 1, 2020Estimated

Completion Date

Apr 30, 2021Estimated

First Submitted Date

Mar 31, 2020

First Submission Date that Met QC Criteria

Mar 31, 2020

First Posted Date

Apr 2, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2020

Last Update Posted Date

Apr 2, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 correct dietary advice to UC patients(Haskkey,N et al 2017).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Ulcerative patients			Dietary Supplement: Diet
Non ulcerative patients			Dietary Supplement: Diet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Diet	Dietary Supplement	Group of diet types	Non ulcerative patients Ulcerative patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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	A year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with ulcerative colitis diagnosed by clinical Endoscopic and histopathological methods

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients with ulcerative colitis with no other comorbidities

Sampling Method

Probability Sample

Intervention Browse Module

MeSH Terms

ID	Term
D004032	Diet

Ancestor Terms

ID	Term
D009747	Nutritional Physiological Phenomena
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided