NCT05876494

Brief Summary

Patients presenting with severe symptoms of ulcerative colitis (UC) require hospital admission for urgent assessment and therapy. Endoscopic examination of the rectum and/or distal colon is often performed to assess severity and obtain tissue for histopathologic evaluation, but this is often extended to full colonoscopy to assess the extent of bowel involvement. Full colonoscopy is hazardous in this setting

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
137

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

May 7, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 25, 2023

Completed
7 days until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

July 20, 2023

Status Verified

July 1, 2023

Enrollment Period

7 months

First QC Date

May 7, 2023

Last Update Submit

July 18, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Accuracy (%) of serum lactate in prediction the acute flare of ulcerative colitis

    By using the receiver operator characteristics curve, we can determine the best cutoff point of serum lactate to predict the acute flare of ulcerative colitis

    one year

Study Arms (1)

patients with ulcerative colitis

any patients with ulcerative colitis

Diagnostic Test: serum lactate

Interventions

serum lactateDIAGNOSTIC_TEST

assessment of serum lactate and mean platelets volume

patients with ulcerative colitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient who is above age of 18 years old and diagnosed to have UC based on combination between clinical, laboratory, radiological, endoscopic and/or histopathological data whatever the course of the disease

You may not qualify if:

  • Patients with inflammatory bowel disease (IBD) other than UC as those with Crohn's disease or microscopic colitis
  • Pregnant patients with ulcerative colitis.
  • Patients with UC who are under age of 18 years old
  • Patient's refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahmed Mohammed Abu-Elfatth

Asyut, 71515, Egypt

RECRUITING

Related Publications (1)

  • Bennike T, Birkelund S, Stensballe A, Andersen V. Biomarkers in inflammatory bowel diseases: current status and proteomics identification strategies. World J Gastroenterol. 2014 Mar 28;20(12):3231-44. doi: 10.3748/wjg.v20.i12.3231.

    PMID: 24696607BACKGROUND

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

ColitisGastroenteritisGastrointestinal DiseasesDigestive System DiseasesInflammatory Bowel DiseasesColonic DiseasesIntestinal Diseases

Study Officials

  • Ahmed M Abu-Elfatth

    Assiut University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ahmed M Abu-Elfatth

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Tropical Medicine and Gastroenterology

Study Record Dates

First Submitted

May 7, 2023

First Posted

May 25, 2023

Study Start

June 1, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

July 20, 2023

Record last verified: 2023-07

Locations