- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04760600
Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome
Study Overview
Status
Conditions
Detailed Description
- Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
- Evaluating the effect of the parasite on the course and prognosis of the diseases.
- Evaluating the effect of the antiparasitic drugs on the course and prognosis of the diseases.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: marina shawqi, md
- Phone Number: 01276121351
- Email: gm161059@gmail.com
Study Contact Backup
- Name: lamia galal
- Phone Number: 01003143075
- Email: lamiazak@gmail.com
Study Locations
-
-
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Assiut, Egypt
- Recruiting
- Marina Gamil Shwqi
-
Contact:
- lamia galal
- Phone Number: +201003143075
- Email: lamiazak@gmail.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Diagnosis of IBD will be confirmed using standard clinical, endoscopic, radiographic and pathological criteria according to the Montreal classification of the extent and severity of IBD The activity of the disease will be measured using the Mayo Clinic score consisting of 4 items: stool frequency, rectal bleeding, findings of flexible proctosigmoidoscopy, and patient's functional assessment Diagnosis of IBS will depend on Rome IV criteria Recurrent abdominal pain on average at least 1 day/week in the last 3 months, associated with two or more of the following criteria: Related to defecation; Associated with a change in the frequency of stool and/ or Associated with a change in the form (appearance) of stool.
- any patient who received antipiotic or antiparasitic drug within the past 4 weeks not taken
Description
Inclusion Criteria:
Diagnosis of IBD will be confirmed using
- standard clinical,
- endoscopic,
- radiographic and4 pathological criteria according to the Montreal classification of the extent and severity of IBD
Diagnosis of IBS will depend on Rome IV criteria
- Recurrent abdominal pain on average at least 1 day/week in the last 3 months,
- associated with two or more of the following criteria:
- Related to defecation;
- Associated with a change in the frequency of stool and/ or Associated with a change in the form (appearance) of stool.
Exclusion Criteria:
- any patient who received antipiotic or antiparasitic drug within the past 4 weeks
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
IBD GROUPS
PATIENT WITH IBD DISEASE
|
IBS GROUP
PATIENT WIT IBS DISEASE
|
CONTROL 1
CONTROL WITH POSITIVE PARASITIC INFECTION AN POSITIVE GIT SYMTOMS
|
CONTROL2
HEALTHY VOLUNTEARS
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
Time Frame: baseline
|
Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.by
making stool analysis and clinical examination
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
measure the effect of the antiparasitic drugs on the course and prognosis of the diseases
Time Frame: baseline
|
giving the patient antiparasitic drug and measure the effect of anti parasitic drug on course and prognosis of disease
|
baseline
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: rasha hassan, Assiut University
- Principal Investigator: mona mostafa, Assiut University
Publications and helpful links
Helpful Links
- Human Intestinal Parasites
- Comparative pathobiology of the intestinal protozoan parasites giardia lamblia, entamoeba histolytica, and cryptosporidium parvum
- Opportunistic infections due to inflammatory bowel disease therapy
- Prevalence of Intestinal Parasitic Infections among the Bulgarian Population Over a Three Year Period
- Soil-transmitted helminth infections: updating the global picture
- Chronic intestinal inflammation: inflammatory bowel disease and colitis-associated colon cancer
- Clinical and Mechanistic Characteristics of Current JAK Inhibitors in IBD
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- role of parasites in ibd ibs
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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