NCT04517240

Brief Summary

The aim of the current study is to investigate if there is GIT involvement in pt's with SLE particularly protein losing enteropathy also its prevalence among the studied cases and it's relation to disease activity .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 18, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

August 18, 2020

Status Verified

August 1, 2020

Enrollment Period

2 years

First QC Date

August 14, 2020

Last Update Submit

August 14, 2020

Conditions

SLE

Outcome Measures

Primary Outcomes (1)

  • early diagnosis of protein losing enteropathy in SLE

    pt with sle have protein losing enteropathy

    baseline

Interventions

endoscopyOTHER

upper and lower endoscopy and fecal calprotectin test

Also known as: fecal calprotectin test

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

pt with systemic lupus with decreased protine in serum and don't have any other disease causing decrease protein

You may qualify if:

  • \- all patients should fulfill ACR(1997)criteria for diagnosis of SLE newly diagnosed and not received immune suppressive regimens

You may not qualify if:

  • Patients with acute gastroenteritis (fever, diarrhea and vomiting) . Patients with renal failure . Patients with heart failure. Patients with hepatic failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Perednia DA, Curosh NA. Lupus-associated protein-losing enteropathy. Arch Intern Med. 1990 Sep;150(9):1806-10.

    PMID: 2203319BACKGROUND

MeSH Terms

Interventions

Endoscopy

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

doaa ramadan

CONTACT

01007749061doaa011180@med.au.edu.eg

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
resident doctor

Study Record Dates

First Submitted

August 14, 2020

First Posted

August 18, 2020

Study Start

October 1, 2020

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

August 18, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share