An Audit on Management of Chronic Diarrhea | NCT03269305

Studies
An Audit on Management of Chronic Diarrhea

NCT03269305

Sponsor

Gehad Adel Mohammed

Status

Completed

Last Update Posted

Dec 8, 2020Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Chronic Diarrhea

Interventions

Not provided

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2017Actual

Primary Completion Date

Sep 1, 2018Actual

Completion Date

Sep 1, 2018Actual

First Submitted Date

Aug 22, 2017

First Submission Date that Met QC Criteria

Aug 30, 2017

First Posted Date

Aug 31, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 4, 2020

Last Update Posted Date

Dec 8, 2020Actual

Name	Class
Assiut University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The study is to assess whether the staff in gastroenterology unit are sticking to the agreed up on unit's protocol in management of chronic diarrhea over the period of one year(september 2017-september 2018)

Detailed Description

chronic diarrhea is defined as having loose or watery stools more than three times aday.Awakening at night to pass stools us often sign of an organic cause of diarrhea.In some cases chronic diarrhea is the result of intestinal infection that persists longer than expected. In other cases chronic diarrhea is apart of a systemic illness.

Etiology:

post enteritis diarrhea syndrome in whic small intestinal mucosal damage persists after acute gastroenteritis.Also secondary disaccharidase deficiency and reinfection may be a cause.
infectious causes:enteric infection is an important cause.Associated conditions may be T.B or impaired immunity as in malnutrition potentiating the likely-hood of prolonging or acquiring another infection.Viral infection like Rota virus,parasites as E.coli,Giardia lamblia as well as amebiasis have been implicated in chronic diarrhea.
Cytomegalovirus on the other hand may act as an opportunistic agent in immuno compromised patients.
Non infectious causes include cow's milk allergy,lactose intolerance and inflammatory bowel disease,all of which may cause chronic diarrhea that is often associated with abdominal pain with or without elevated levels of inflammatory markers.
Malabsorption syndrome e.g Celiac disease,cystic fibrosis where the stools are usually fatty in nature and bulky in amount.

Good management of chronic diarrhea must include investigations and treatment.A protocol must be followed accurately therefore.

Methodology:

measurment of the degree of sticking of staff in Gastro-enterology unit to the agreed upon unit's protocol in management of chronic diarrhea over the period of one year (September 2017-September 2018).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
proper management of chronic diarrhea	start accurate treatment of chronic diarrhea by reaching a definitive cause of each case . decrease the incidence of undiagnosed cases of chronic diarrhea	september 2017-september 2018

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age group from 2 months to 18 years
cases with diarrhea lasts 2 weeks or more
Genetically free

Exclusion Criteria:

age group from 0-2 months
age group above 18 years
cases with diarrhea less than 2 weeks
Gentic disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

an audit

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Faisal Alkhateeb, Phd	Assiut University	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gehad		Asyut			Egypt