NCT05830370

Brief Summary

Irritable bowel syndrome (IBS) is common medical disorder and represent a group of diseases of the gastrointestinal tract that is characterized by chronic abdominal pain , bloating , passage of mucus or straining with bowel movements, sense of incomplete evacuation after bowel movements or sense of urgency to move the bowels.Several parasites including Entamoeba. histolytica, Giardia spp., Blastocystis. hominis, and Trichinella spp. have been discussed as contributing factors to the development of IBS. B. hominis is one of the most common human intestinal protozoa in both developing and developed countries. some studies have reported a significant association between the parasitic infections, especially Blastocystis, and IBS.Cryptosporidium has been reported in IBS patients, with the onset of gastrointestinal symptoms after an acute episode of cryptosporidiosis despite recovery and parasite clearance.Numerous studies have been conducted to evaluate the association between the parasitic infections and IBS. Aim of the work: To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2023

Shorter than P25 for all trials

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

April 12, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 26, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

May 1, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

April 26, 2023

Status Verified

April 1, 2023

Enrollment Period

7 months

First QC Date

April 12, 2023

Last Update Submit

April 14, 2023

Conditions

Keywords

irritable bowel syndromeentamoebahistolyticaBlastocystishominischronic abdominal paindiarrheadefecationconstipationbloatingTrichinellaCryptosporidium

Outcome Measures

Primary Outcomes (1)

  • To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.

    will collect 200 stool samples : 100 samples will be collected from patients complaining of symptoms of IBS fulfilling the Rome criteria , such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups from different locations (cities and village) And 100 samples healthy controls.the samples will be examined for parasitological examination to detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients.

    16 weeks following the startpoint of the study.

Study Arms (2)

case

patients complaining of symptoms of IBS fulfilling the Rome criteria , such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups from different locations.

control

healthy individuals not suffering from IBS symptoms such as abdominal discomfort, diarrhea, and constipation, bloating.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

samples will be collected from outpatients complaining of symptoms of IBS fulfilling the Rome criteria , such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups from different locations (cities and village).

You may qualify if:

  • Patients complaining of symptoms of IBS, such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups

You may not qualify if:

  • Patients have celiac disease, gastrointestinal malignancies , inflammatory bowel disease , HIV , and those on immunosuppression and those who had been recently taking antibiotics within the previous four weeks and anti-parasitic drugs within the previous two weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine Sohag University

Sohag, 093, Egypt

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

stool specimens

MeSH Terms

Conditions

Irritable Bowel SyndromeDiarrheaConstipation

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Demonstrator at medical parasitology department.

Study Record Dates

First Submitted

April 12, 2023

First Posted

April 26, 2023

Study Start

May 1, 2023

Primary Completion

November 30, 2023

Study Completion

January 1, 2024

Last Updated

April 26, 2023

Record last verified: 2023-04

Locations