Parasite IBS IBDNCT04760600
Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome
An observational study of Parasite IBS IBD, run by Assiut University at 1 site in Egypt.
Trial 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 . Read more about this study
- Who is it for?
- Ages 17 to 69 yearsHealthy volunteers can take part
- Conditions the study is for
- Parasite IBS IBD
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2021to Jun 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 17 to 69 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Diagnosis of IBD will be confirmed using
- standard clinical,
- endoscopic,
- 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
- Recurrent abdominal pain on average at least 1 day/week in the last 3 months,
Show all 9Show fewer
- 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.
Who cannot join
- any patient who received antipiotic or antiparasitic drug within the past 4 weeks
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Marina Gamil Shwqi
Asyut
lamia galal, +201003143075, lamiazak@gmail.com
About this study
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
Read the detailed description
- Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
- Evaluating the effect of the parasite on the course and prognosis of the diseases.
- Evaluating the effect of the antiparasitic drugs on the course and prognosis of the diseases.
- Conditions
- Parasite IBS IBD
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 |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
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
Measured: baseline
Secondary outcomes (1)
measure the effect of the antiparasitic drugs on the course and prognosis of the diseases
giving the patient antiparasitic drug and measure the effect of anti parasitic drug on course and prognosis of disease
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study startJun 2021 (estimated)
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parasite IBS IBDStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marina gamil shwqi, Assiut University
- Investigators
- rasha hassan, Principal investigator, Assiut Universitymona mostafa, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04760600
- Sponsor's protocol ID
- role of parasites in ibd ibs
- Status last verified
- Jan 2021
- First submitted
- 5 Feb 2021
- Last updated
- 18 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Parasitic Infection in Inflammatory Bowel Disease and Irritable Bowel Syndrome
- ClinicalTrials.gov ID
- NCT04760600
- Acronym / sponsor ID
- role of parasites in ibd ibs
- Conditions
- Parasite IBS IBD
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jun 2021 (estimated)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 18 Feb 2021 (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.
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
- Detect the prevalence of parasite/s associated with Inflammatory bowel diseases (IBD) and Irritable bowel syndrome (IBS) in comparison with control subjects.
- Evaluating the effect of the parasite on the course and prognosis of the diseases.
- Evaluating the effect of the antiparasitic drugs on the course and prognosis of the diseases.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 17 to 69 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (9 listed)
- Diagnosis of IBD will be confirmed using
- Diagnosis of IBS will depend on Rome IV criteria
Key exclusion criteria (1 listed)
- any patient who received antipiotic or antiparasitic drug within the past 4 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
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
1 secondary outcome
measure the effect of the antiparasitic drugs on the course and prognosis of the diseases
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
- Human Intestinal ParasitesLink provided by the sponsor.
- Comparative pathobiology of the intestinal protozoan parasites giardia lamblia, entamoeba histolytica, and cryptosporidium parvumLink provided by the sponsor.
- Opportunistic infections due to inflammatory bowel disease therapyLink provided by the sponsor.
- Prevalence of Intestinal Parasitic Infections among the Bulgarian Population Over a Three Year PeriodLink provided by the sponsor.
- Soil-transmitted helminth infections: updating the global pictureLink provided by the sponsor.
- Chronic intestinal inflammation: inflammatory bowel disease and colitis-associated colon cancerLink provided by the sponsor.
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.
rasha hassan principal investigator
Assiut University
mona mostafa principal investigator
Assiut University
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 Parasite IBS IBD, run by Assiut 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 9 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 18 Feb 2021. 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 marina shawqi, md (01276121351, gm161059@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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 18 Feb 2021.