Diarrhea, SecretoryNCT03166670
Parasitic Causes of Secretory Diarrhea in Children and Chronically Ill Adult.
An observational study of Diarrhea, Secretory, run by Assiut University at 1 site in Egypt.
Trial summary
Diarrhea is one of the most common reasons for people to seek medical advice - but it can range from being a mild, temporary condition, to be life threading condition. It is estimated that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million children below the age of 5 years, mostly… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Secretory
- What is being tested?
- stool examination and real time polymerase chain reaction
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2018to 12 Apr 2021
- 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: -Children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of Assiut University pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period. 2-adult patients having acute watery diarrhea attend to out clinic labs of Assiut University hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period.
Who may be able to join
- Children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of Assiut University pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period.
- adult patients having acute watery diarrhea attend to out clinic labs of Assiut University hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period.
Who cannot join
- viral and bacterial causes of diarrhea
- Patients who were already diagnosed as intestinal inflammatory disease as irritable bowel syndrome.
- Autoimmune conditions, such as ulcerative colitis, Crohn's disease and coeliac disease.
Trial locations and contacts
1 site in 1 country.
About this study
Diarrhea is one of the most common reasons for people to seek medical advice - but it can range from being a mild, temporary condition, to be life threading condition. It is estimated that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million children below the age of 5 years, mostly in developing countries, die annually.
Read the detailed description
Secretory diarrhea has many causes as infection with bacteria, viruses or protozoa. It results from increased chloride secretion, decreased sodium absorption, or increased mucosal permeability . Parasitic pathogens induce Secretory diarrhea as they infect and damage the absorptive villus tips, leaving Secretory crypts unbalanced, to cause net secretion and diarrhea. Parasitic causes include Cryptosporidium parvum or hominis ,Capillaria philippinensis and Giardia lamblia. Cryptosporidiosis is also recognized as a cause of prolonged and persistent diarrhea in children and persons with impaired immunity. The disease is transmitted via the fecal-oral route from infected hosts. It can be also transmitted following animal contact, ingestion of water (mainly during swimming), or through food. Cryptosporidium has emerged as the most frequently recognized cause of water-associated outbreaks of gastroenteritis. This is because of the oocyst stage in its life cycle; Cryptosporidium can resist disinfection, including chlorination, and can survive for a prolonged period in the environment.
- Conditions
- Diarrhea, Secretory
- Being tested
- stool examination, real time polymerase chain reaction
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stool examinationDiagnostic test
collection of stool specimen and microscopic examination for parasites
real time polymerase chain reactionDiagnostic test
evaluation of genotype of cryptosporidium in stool specimen
| Study group | Role | What they receive |
|---|---|---|
| study group | children with acute secretory diarrhea Receives: Diagnostic Test: stool examination; Diagnostic Test: real time polymerase chain reaction | |
| Control group | normal healthy children Receives: Diagnostic Test: stool examination; Diagnostic Test: real time polymerase chain reaction |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of patients with positive stool analysis for cryptosporidium
Use of microscopic examination and real time polymerase chain reaction
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2017
- Study start1 Jan 2018
- Primary completion1 Apr 2021
- Study completion12 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhea, SecretoryStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Elderwy, Assiut University
- Investigators
- Asmaa M Abd elaziz, MD, Principal investigator, Assuit University, Faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03166670
- Sponsor's protocol ID
- PSDCC
- Status last verified
- Jun 2021
- First submitted
- 24 May 2017
- Last updated
- 8 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pawlowski SW, Warren CA, Guerrant R. Diagnosis and treatment of acute or persistent diarrhea. Gastroenterology. 2009 May;136(6):1874-86. doi: 10.1053/j.gastro.2009.02.072. Epub 2009 May 7.
PubMed 19457416
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parasitic Causes of Secretory Diarrhea in Children and Chronically Ill Adult.
- ClinicalTrials.gov ID
- NCT03166670
- Acronym / sponsor ID
- PSDCC
- Conditions
- Diarrhea, Secretory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 12 Apr 2021 (actual)
- First posted
- 25 May 2017 (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.
Diarrhea is one of the most common reasons for people to seek medical advice - but it can range from being a mild, temporary condition, to be life threading condition. It is estimated that there are 2 billion cases of diarrheal disease every year globally, and that 1.9 million children below the age of 5 years, mostly in developing countries, die annually.
Detailed description
Secretory diarrhea has many causes as infection with bacteria, viruses or protozoa. It results from increased chloride secretion, decreased sodium absorption, or increased mucosal permeability . Parasitic pathogens induce Secretory diarrhea as they infect and damage the absorptive villus tips, leaving Secretory crypts unbalanced, to cause net secretion and diarrhea. Parasitic causes include Cryptosporidium parvum or hominis ,Capillaria philippinensis and Giardia lamblia. Cryptosporidiosis is also recognized as a cause of prolonged and persistent diarrhea in children and persons with impaired immunity. The disease is transmitted via the fecal-oral route from infected hosts. It can be also transmitted following animal contact, ingestion of water (mainly during swimming), or through food. Cryptosporidium has emerged as the most frequently recognized cause of water-associated outbreaks of gastroenteritis. This is because of the oocyst stage in its life cycle; Cryptosporidium can resist disinfection, including chlorination, and can survive for a prolonged period in the environment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| study group | – | Diagnostic Test: stool examination, Diagnostic Test: real time polymerase chain reactionchildren with acute secretory diarrhea |
| Control group | – | Diagnostic Test: stool examination, Diagnostic Test: real time polymerase chain reactionnormal healthy children |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- -Children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of Assiut University pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period. 2-adult patients having acute watery diarrhea attend to out clinic labs of Assiut University hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period.
Key inclusion criteria (2 listed)
- Children presented with secretory diarrhea(acute watery diarrhea) attend to out clinic lab of Assiut University pediatric hospital or admitted in pediatric hospital(gastroenterology department) during the study period.
- adult patients having acute watery diarrhea attend to out clinic labs of Assiut University hospital or admitted in gastroenterology, nephrology and oncology department of hospital during the study period.
Key exclusion criteria (3 listed)
- viral and bacterial causes of diarrhea
- Patients who were already diagnosed as intestinal inflammatory disease as irritable bowel syndrome.
- Autoimmune conditions, such as ulcerative colitis, Crohn's disease and coeliac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stool examinationcollection of stool specimen and microscopic examination for parasites | Diagnostic test | Control group, study group |
| real time polymerase chain reactionevaluation of genotype of cryptosporidium in stool specimen | Diagnostic test | Control group, study group |
Primary outcome
percentage of patients with positive stool analysis for cryptosporidium
Time frame: 2 days
Use of microscopic examination and real time polymerase chain reaction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2021.
- Background: PubMed 19457416Pawlowski SW, Warren CA, Guerrant R. Diagnosis and treatment of acute or persistent diarrhea. Gastroenterology. 2009 May;136(6):1874-86. doi: 10.1053/j.gastro.2009.02.072. Epub 2009 May 7.
- Individual participant dataSharing planned: No
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.
Asmaa M Abd elaziz, MD principal investigator
Assuit University, Faculty of medicine
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 Diarrhea, Secretory, 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 8 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of patients with positive stool analysis for cryptosporidium (time frame: 2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03166670, which also lists 1 linked publication.
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 8 Jun 2021.