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Chronic DiarrheaNCT03261297

Epidemiology of Chronic Diarrhea Among Children Admitted to Gastroenterology Unit at Assuit University Children Hospital

An observational study of Chronic Diarrhea, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Chronic diarrhea is defined as stool volume of more than 10g/kg/day in toddlers/infants and greater than 200 g/day in older children that lasts for 14 days or more. Chronic diarrhea has many of causes can calcified as infectious \& noninfectious causes. Read more about this study

Who is it for?
Ages 1 month to 17 years
Conditions the study is for
Chronic Diarrhea
How many people
50 participants
Where
1 siteEgypt
Study dates
22 Aug 2017to 22 Aug 2018
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 1 month to 17 years
  • All sexes
  • Child

Study population: epidemiological study

Who may be able to join

  • 1. -all patient from 1 month up to 17 years (1month-17 year) admitted gastroenterology unit at Assuit University Children Hospital 2. Diarrhea 14 days or more ( ≥14 day)

Who cannot join

  • 1. age less than 1 month (≤1 month) 2. diarrhea less than 14 days (≤14 day) 3. chronic diarrhea due to malignancy \& chemotherapy

Trial locations and contacts

1 site in 1 country.

moustafa abd ellatif contact

0127706049

drtifa1990@gmail.com

Egypt1 site, 1 recruiting
  • Moustafa Abd Ellatif

    Asyut

    Recruiting

Other trials in Egypt

About this study

Chronic diarrhea is defined as stool volume of more than 10g/kg/day in toddlers/infants and greater than 200 g/day in older children that lasts for 14 days or more.

Chronic diarrhea has many of causes can calcified as infectious \& noninfectious causes.

Read more
  • Infectious causes as: - Escherichia coli, Giardia Lamblia, tuberculosis, Clostridium difficile \& Shigella.
  • Noninfectious causes as(Abnormal digestive processes- Nutrient Mal -absorption- Immune/ inflammatory- Defects of electrolyte And metaboliteTransport- Motility disorders- Diarrhea associated With exogenous substances)

There are four basic pathophysiological categories of diarrhea: as ( osmotic diarrhea- secretory diarrheas- motility related diarrhea- Inflammatory diarrhea)

Read the detailed description

Infectious diarrhea caused by invasive bacteria (Shigella, Salmonella, Campylobacter) or a cytotoxic organism result ting in mucosal histologic damage and inflammation (Entamoeba histolytica). (Hedberg etal., 1994)

Giardia lamblia Transmission is via the faecal oral route or via ingestion of contaminated water sources. Symptoms of Giardia infection include diarrhea, malaise, flatulence, foul smelling greasy stools, bloating/ distention and, less commonly, nausea, anorexia and vomiting. (Dib etal., 2008)

Entamoeba histolytica is the causative agent of amoebiasis. The majority of patients will have asymptomatic or low level disease with a gradual onset of diarrhea with generalized abdominal tenderness. Fever is not usually associated with amoebic disease. Mucus and/or blood may be present if the organism penetrates the bowel wall and causes mucosal damage. (Van Hal etal., 2007)

Inflammatory bowel diseases, including Crohn disease \& ulcerative colitis ,cause chronic diarrhea that is often associated with abdominal pain, elevated inflammatory markers, and increased concentrations of fecal calprotectin. The severity of the symptoms is highly variable with a pattern characterized by long periods of well-being followed by exacerbations (Bunn etal., 2001)

Lactose is the sugar found in milk .Because lactose is not digested properly in the small intestine of individuals who are lactose intolerant; it passes whole into the large intestine or colon. Upon reaching the colon it is broken down by the normal colon bacteria. This breakdown results in the production of carbon dioxide and hydrogen gases. The gas production can lead to (Abdominal distension, excess gas and diarrhea, watery and explosive bowel movements, urgency). The severity of symptoms is usually proportional to the amount of the milk sugar ingested with more symptoms following a meal with higher milk sugar content. (Marsha, 2012).

There are four basic pathophysiological categories of diarrhea:

In osmotic diarrheas, osmotically active substances draw fluids from the plasma into the jejunum along the osmotic gradients through the highly permeable jejunal epithelium. Examples of chronic diarrhea due to an osmotic cause include malabsorption states such as celiac disease, bacterial overgrowth, osmotic laxatives including salts, and lactulose and maldigestion as occurs in disaccharidase deficiency and pancreatic exocrine insufficiency.Osmotic diarrheas might result in steatorrhea (passage of fat in to the stool). (Pardi etal., 2002)

In secretory diarrheas, there is secretion of isoosmolar fluid into the intestine. In this situation, other electrolyte abnormalities might coexist. Thus, hypokalemia and acidosis are associated with Verner-Morrison syndrome or VIPoma; Examples of secretory diarrheas include congenital abnormalities such as congenital chloridorrhea, in which an abnormality in the genetic control of chloride-bicarbonate exchange in the ileum results in the loss of chloride into the stool. (Long etal., 1981) Secretory diarrhea might be associated with altered motor functions induced by the hormone or transmitter produced by the tumor, as in carcinoid diarrhea. (Von etal., 1993) The typical features of secretory diarrhea include the persistence of the diarrhea with fasting and the absence of steatorrhea, hypokalemia and acidosis typically suggest VIPoma syndrome (Camilleri etal., 1982)

In motility related diarrhea, Motility disorders cause diarrhea by either accelerating gastrointestinal transit (e.g., post vagotomy diarrhea) or by slowing transit, thereby predisposing to small intestinal bacterial overgrowth (SIBO) (e.g., scleroderma).The most prevalent forms of motility-related diarrheas is IBS-D, Rapid small-bowel transit is a relatively common finding in patients with diabetes or autonomic neuropathies, or patients who have undergone upper gastrointestinal tract surgery. (Posserud etal., 2007)

In Inflammatory diarrhea occurs when there is damage to the mucosal lining or brush border, which leads to a passive loss of protein-rich fluids and a decreased ability to absorb these lost fluids. It can be caused by bacterial infections, viral infections, parasitic infections, or autoimmune problems. It can also be caused by tuberculosis, colon cancer, and enteritis (Camilleri etal., 2014)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Identify the prevalence of chronic diarrhea at Gastroenterology unit at Assuit University Children Hospital

    Not yet recruiting: Participants are not yet being recruited

    Measured: one year

Secondary outcomes (1)
  1. improve hospital to meet the most common couse of diarrha in our hospital

    Not yet recruiting: Participants are not yet being recruited

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Aug 2017
  2. Study start22 Aug 2017
  3. Primary completion22 Aug 2017
  4. Study completion22 Aug 2018 (estimated)

Resources

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
Cohort
Time perspective
Prospective
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03261297
Sponsor's protocol ID
17100287
Status last verified
Aug 2017
First submitted
22 Aug 2017
Last updated
25 Aug 2017
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Diarrhea, 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 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 25 Aug 2017. 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 moustafa abd ellatif (0127706049, drtifa1990@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Identify the prevalence of chronic diarrhea at Gastroenterology unit at Assuit University Children Hospital (time frame: one year). 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 25 Aug 2017.

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