Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome

February 15, 2021 updated by: marina gamil shwqi, Assiut University
Role of parasitic infection in Inflammatory bowel disease and Irritable bowel The burden of the parasitic disease is in-direct relation with the health and nutritional status of the host, inducing not only parasite-specific immunity but also can modify the host's immune responses . Many parasites can imitate inflammatory bowel disorders and some studies showed that infection with parasites can improve disorders like IBD or moderate the symptoms of inflammatory bowel disorders . Even though, many studies have shown that gastrointestinal infection is an important risk factor for the development of IBS

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
  2. Evaluating the effect of the parasite on the course and prognosis of the diseases.
  3. Evaluating the effect of the antiparasitic drugs on the course and prognosis of the diseases.

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Assiut, Egypt
        • Recruiting
        • Marina Gamil Shwqi
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 69 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

    1. standard clinical,
    2. endoscopic,
    3. 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

    1. Recurrent abdominal pain on average at least 1 day/week in the last 3 months,
    2. associated with two or more of the following criteria:
    3. Related to defecation;
    4. 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: rasha hassan, Assiut University
  • Principal Investigator: mona mostafa, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2021

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2024

Study Registration Dates

First Submitted

February 5, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 18, 2021

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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