Irritable Bowel SyndromeNCT05830370
Prevalence of Intestinal Parasitic Infections in Patients With Irritable Bowel Syndrome
An observational study of Irritable Bowel Syndrome, run by Sohag University at 1 site in Egypt.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Irritable Bowel Syndrome
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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).
Who may be able to join
- Patients complaining of symptoms of IBS, such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine Sohag University
Sohag, 093
Nada Mahmoud Ahmed, 01069122479 ext. +20, nadamahmoud@med.sohag.edu.eg
About this study
Official title: Prevalence of Intestinal Parasitic Infections in Irritable Bowel Syndrome Patients in Sohag, Egypt
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.
- 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.
Read more
Aim of the work:
To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, entamoeba, histolytica, Blastocystis, hominis, chronic abdominal pain, diarrhea, defecation, constipation, bloating, Trichinella, Cryptosporidium
- Medical subject headings
- Irritable Bowel Syndrome, Diarrhea, Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks following the startpoint of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start1 May 2023 (estimated)
- Primary completion30 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mahmoud Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830370
- Sponsor's protocol ID
- Soh-Med-23-04-23MS
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 26 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Intestinal Parasitic Infections in Irritable Bowel Syndrome Patients in Sohag, Egypt
- ClinicalTrials.gov ID
- NCT05830370
- Acronym / sponsor ID
- Soh-Med-23-04-23MS
- Conditions
- Irritable Bowel Syndrome
- Keywords
- irritable bowel syndrome, entamoeba, histolytica, Blastocystis, hominis, chronic abdominal pain, diarrhea, defecation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 26 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Case-control
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (1 listed)
- Patients complaining of symptoms of IBS, such as abdominal discomfort, diarrhea, and constipation, bloating with any age \& sex groups
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag.
Time frame: 16 weeks following the startpoint of the study.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: Undecided. undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Irritable Bowel Syndrome, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nada Mahmoud Ahmed (01069122479 ext. +20, nadamahmoud@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To detect prevalence of intestinal parasitic infections in irritable bowel syndrome patients in sohag. (time frame: 16 weeks following the startpoint of the study.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2023.