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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Egypt
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Assiut University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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.

Helpful Links

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 5, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 18, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • role of parasites in ibd ibs

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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