NCT04921709

Brief Summary

To evaluate renal involvement in inflammatory bowel disease patients .

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

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

March 3, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2023

Completed
Last Updated

June 10, 2021

Status Verified

June 1, 2021

Enrollment Period

1.3 years

First QC Date

March 3, 2021

Last Update Submit

June 4, 2021

Conditions

Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

  • correlation between lab, radiological and colonoscopy

    All patients will be subjected to full clinical history , examination and investigation .investigations will include: A-Laboratory tests: * CBC * urine analysis * calculating the estimated glomerular filtration rate (eGFR) * 24hr urinary protein * hepatitis markers ,liver function tests * kidney function tests. * -kidney biopsy for patients with renal involvement if needed * ANA, Anti ds * blood electrolyte ( Na, K, Ca , Mg ) B- Radiological: abdominal ultrasonography C- colonoscopy . to evaluate renal ivolvement in inflammatory bowel disease

    Baseline

Study Arms (2)

IBD Patients with Renal Involvement

1. Inclusion criteria: - patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have renal problems . Age (18-65 years) 2. Exclusion criteria: 1-patients underage of 18 2-HCV or HBV patients 3- renal patients diagnosed before diagnosis of IBD 4- diabetic or hypertensive patients 5- other autoimmune diseases such as Rheumatoid Arthritis, SLE. 6- Malignancy

Other: Medical tests

IBD Patients without Renal Involvement

1. Inclusion criteria: - patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have no renal problems . Age (18-65 years) 2. Exclusion criteria: 1-patients underage of 18 2-HCV or HBV patients 3- renal patients diagnosed before diagnosis of IBD 4- diabetic or hypertensive patients 5- other autoimmune diseases such as Rheumatoid Arthritis, SLE. 6- Malignancy

Other: Medical tests

Interventions

Medical testsOTHER

Blood tests

IBD Patients with Renal InvolvementIBD Patients without Renal Involvement

Eligibility Criteria

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

cohort study

You may qualify if:

  • patients with IBD diagnosed by colonoscopy and histopathology will classify the activity of the case to mild ,moderate and severe according to Mayo classification and have renal problems .
  • Age (18 - 65 years)

You may not qualify if:

  • patients underage of 18
  • HCV or HBV patients
  • renal patients diagnosed before diagnosis of IBD
  • diabetic or hypertensive patients
  • other autoimmune diseases such as Rheumatoid Arthritis, SLE.
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hend Hamdy Tawfik

Minya, Egypt

RECRUITING

Related Publications (3)

  • Oikonomou K, Kapsoritakis A, Eleftheriadis T, Stefanidis I, Potamianos S. Renal manifestations and complications of inflammatory bowel disease. Inflamm Bowel Dis. 2011 Apr;17(4):1034-45. doi: 10.1002/ibd.21468. Epub 2010 Sep 14.

    PMID: 20842645BACKGROUND

  • Pardi DS, Tremaine WJ, Sandborn WJ, McCarthy JT. Renal and urologic complications of inflammatory bowel disease. Am J Gastroenterol. 1998 Apr;93(4):504-14. doi: 10.1111/j.1572-0241.1998.156_b.x.

    PMID: 9576439BACKGROUND

  • Yoo YJ, Chung SY, Gu DH, Ko GJ, Pyo HJ, Kwon YJ, Bak YT, Won NH. A case of late onset-acute tubulointerstitial nephritis with infliximab and mesalazine treatment in a patient with Crohn's disease. Korean J Gastroenterol. 2014 May;63(5):308-12. doi: 10.4166/kjg.2014.63.5.308.

    PMID: 24870303BACKGROUND

MeSH Terms

Conditions

Irritable Bowel Syndrome

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Enas A Reda Alkaremy, Prof

    Alkareemy@yahoo.com

    STUDY DIRECTOR

Central Study Contacts

Hend H Tawfik, Res

CONTACT

00201226253775hend25793@gmail.com

Enas A Reda Alkaremy, Prof

CONTACT

00201000004303Alkareemy@yahoo.com

Study Design

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

Study Record Dates

First Submitted

March 3, 2021

First Posted

June 10, 2021

Study Start

June 1, 2021

Primary Completion

October 1, 2022

Study Completion

January 1, 2023

Last Updated

June 10, 2021

Record last verified: 2021-06

Locations

EG(1)