NCT05974332

Brief Summary

Ulcerative colitis (UC) is a refractory disease characterized by symptoms such as diarrhea, bloody stools, and abdominal pain with repeated relapses and remissions.

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
99

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 for not_applicable

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

July 26, 2023

Completed
6 days until next milestone

Study Start

First participant enrolled

August 1, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2024

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

August 3, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

July 26, 2023

Last Update Submit

July 26, 2023

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

  • Identify if oncostatin M is a good marker

    Diagnosis of Ulcerative colitis and follow up

    6 months

Study Arms (2)

Ulcerative colitis Patients

ACTIVE COMPARATOR

45 Patients with UC. The diagnosis of UC will be based on endoscopic finding and histopathological finding

Diagnostic Test: Oncostatin M

Control

ACTIVE COMPARATOR

45 apparently healthy subjects as controls who were not UC

Diagnostic Test: Oncostatin M

Interventions

Oncostatin MDIAGNOSTIC_TEST

Test to diagnosis of Ulcerative colitis

ControlUlcerative colitis Patients

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients aged \>18 years and \<80 years, of both gender who diagnosed to have UC and given the consent for participation in the study

You may not qualify if:

  • Any patient with systemic inflammation as Bronchial asthma. 2- History of cancer or tumor. 3- Autoimmune disease such as rheumatoid arthritis and systemic lupus erythematous

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

July 26, 2023

First Posted

August 3, 2023

Study Start

August 1, 2023

Primary Completion

February 28, 2024

Study Completion

March 1, 2024

Last Updated

August 3, 2023

Record last verified: 2023-07