Clinical trial NCT04760600: Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome
Official title: Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parasite IBS IBD
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-02-18
Enrollment: 300
Sex: ALL
Minimum age (years): 17
Maximum age (years): 69
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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

Brief summary: 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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
timeFrame: baseline
Secondary outcomes:
measure: measure the effect of the antiparasitic drugs on the course and prognosis of the diseases
timeFrame: baseline
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Marina Gamil Shwqi
Study officials:
affiliation: Assiut University
name: rasha hassan
role: PRINCIPAL_INVESTIGATOR
affiliation: Assiut University
name: mona mostafa
role: PRINCIPAL_INVESTIGATOR
References: