NCT05406934

Brief Summary

ulcerative colitis and Crohn's disease, the two major forms of inflammatory bowel disease, are chronic, idiopathic, relapsing inflammatory conditions of the gastrointestinal tract. The mechanism is multifactorial and may result from the combined interaction of environmental, genetic, epithelial barrier defects, dysregulated immune responses, and microbial factors

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
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2022

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

January 17, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

June 5, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 7, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

June 7, 2022

Status Verified

June 1, 2022

Enrollment Period

Same day

First QC Date

January 17, 2022

Last Update Submit

June 4, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • detect of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.

    Evaluation of disease activity of IBD patients received biological treatment in the start and in 14 weeks after treatment compared to whose controlled by platelet indices and platelet lymphocytic ratio.

    about 14 weeks after start of treatment of inflixmab

Study Arms (3)

healthy group

the healthy group, not diagnosed IBD

Biological: Infliximab

IBD patients controlled by conventional treatment

controlled by conventional treatment and divided to UC group and Crohns group

Biological: Infliximab

uncontrolled IBD patients on biological's treatment

divided to uc received biological and Crohns received biolgical

Biological: Infliximab

Interventions

InfliximabBIOLOGICAL

obseravation with investigation

IBD patients controlled by conventional treatmenthealthy groupuncontrolled IBD patients on biological's treatment

Eligibility Criteria

Age21 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

study will include 120 persons divided to 30 healthy persons and 90 was diagnosed inflammatory bowel disease in Asyut university hospital , 60 of those patients diagnosed ulcerative colitis , 30 of them controlled on conventional treatment , 30 patients on biological treatment and 30 patients' crohn's disease , 15 of them controlled on conventional treatment and 15 patients on biological treatment

You may qualify if:

  • All patients diagnosed with inflammatory bowel disease ulcerative colitis or crohn's disease
  • All IBD patients received biological treatment
  • All IBD patients controlled with conventional treatment

You may not qualify if:

  • IBS patients
  • IBD Patients with: a) another autoimmune disease like ITP and SLE B) Bleeding tendency as hemophilia or thrombophilia C) Previous thrombotic events or on anticoagulants or antiplatelet drugs D) With another comorbidity as liver cell failure, respiratory failure, renal failure and cardiac failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Intestinal DiseasesInflammatory Bowel Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesGastroenteritis

Intervention Hierarchy (Ancestors)

Antibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

January 17, 2022

First Posted

June 7, 2022

Study Start

June 5, 2022

Primary Completion

June 5, 2022

Study Completion

October 1, 2024

Last Updated

June 7, 2022

Record last verified: 2022-06