<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03261297</url>
  </required_header>
  <id_info>
    <org_study_id>17100287</org_study_id>
    <nct_id>NCT03261297</nct_id>
  </id_info>
  <brief_title>Epidemiology of Chronic Diarrhea Among Children Admitted to Gastroenterology Unit at Assuit University Children Hospital</brief_title>
  <official_title>Epidemiology of Chronic Diarrhea Among Children Admitted to Gastroenterology Unit at Assuit University Children Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic diarrhea is defined as stool volume of more than 10g/kg/day in toddlers/infants and&#xD;
      greater than 200 g/day in older children that lasts for 14 days or more.&#xD;
&#xD;
      Chronic diarrhea has many of causes can calcified as infectious &amp; noninfectious causes.&#xD;
&#xD;
        -  Infectious causes as: - Escherichia coli, Giardia Lamblia, tuberculosis, Clostridium&#xD;
           difficile &amp; Shigella.&#xD;
&#xD;
        -  Noninfectious causes as(Abnormal digestive processes- Nutrient Mal -absorption- Immune/&#xD;
           inflammatory- Defects of electrolyte And metaboliteTransport- Motility disorders-&#xD;
           Diarrhea associated With exogenous substances)&#xD;
&#xD;
      There are four basic pathophysiological categories of diarrhea: as ( osmotic diarrhea-&#xD;
      secretory diarrheas- motility related diarrhea- Inflammatory diarrhea)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Infectious diarrhea caused by invasive bacteria (Shigella, Salmonella, Campylobacter) or a&#xD;
      cytotoxic organism result ting in mucosal histologic damage and inflammation (Entamoeba&#xD;
      histolytica). (Hedberg etal., 1994)&#xD;
&#xD;
      Giardia lamblia Transmission is via the faecal oral route or via ingestion of contaminated&#xD;
      water sources. Symptoms of Giardia infection include diarrhea, malaise, flatulence, foul&#xD;
      smelling greasy stools, bloating/ distention and, less commonly, nausea, anorexia and&#xD;
      vomiting. (Dib etal., 2008)&#xD;
&#xD;
      Entamoeba histolytica is the causative agent of amoebiasis. The majority of patients will&#xD;
      have asymptomatic or low level disease with a gradual onset of diarrhea with generalized&#xD;
      abdominal tenderness. Fever is not usually associated with amoebic disease. Mucus and/or&#xD;
      blood may be present if the organism penetrates the bowel wall and causes mucosal damage.&#xD;
      (Van Hal etal., 2007)&#xD;
&#xD;
      Inflammatory bowel diseases, including Crohn disease &amp; ulcerative colitis ,cause chronic&#xD;
      diarrhea that is often associated with abdominal pain, elevated inflammatory markers, and&#xD;
      increased concentrations of fecal calprotectin. The severity of the symptoms is highly&#xD;
      variable with a pattern characterized by long periods of well-being followed by exacerbations&#xD;
      (Bunn etal., 2001)&#xD;
&#xD;
      Lactose is the sugar found in milk .Because lactose is not digested properly in the small&#xD;
      intestine of individuals who are lactose intolerant; it passes whole into the large intestine&#xD;
      or colon. Upon reaching the colon it is broken down by the normal colon bacteria. This&#xD;
      breakdown results in the production of carbon dioxide and hydrogen gases. The gas production&#xD;
      can lead to (Abdominal distension, excess gas and diarrhea, watery and explosive bowel&#xD;
      movements, urgency). The severity of symptoms is usually proportional to the amount of the&#xD;
      milk sugar ingested with more symptoms following a meal with higher milk sugar content.&#xD;
      (Marsha, 2012).&#xD;
&#xD;
      There are four basic pathophysiological categories of diarrhea:&#xD;
&#xD;
      In osmotic diarrheas, osmotically active substances draw fluids from the plasma into the&#xD;
      jejunum along the osmotic gradients through the highly permeable jejunal epithelium. Examples&#xD;
      of chronic diarrhea due to an osmotic cause include malabsorption states such as celiac&#xD;
      disease, bacterial overgrowth, osmotic laxatives including salts, and lactulose and&#xD;
      maldigestion as occurs in disaccharidase deficiency and pancreatic exocrine&#xD;
      insufficiency.Osmotic diarrheas might result in steatorrhea (passage of fat in to the stool).&#xD;
      (Pardi etal., 2002)&#xD;
&#xD;
      In secretory diarrheas, there is secretion of isoosmolar fluid into the intestine. In this&#xD;
      situation, other electrolyte abnormalities might coexist. Thus, hypokalemia and acidosis are&#xD;
      associated with Verner-Morrison syndrome or VIPoma; Examples of secretory diarrheas include&#xD;
      congenital abnormalities such as congenital chloridorrhea, in which an abnormality in the&#xD;
      genetic control of chloride-bicarbonate exchange in the ileum results in the loss of chloride&#xD;
      into the stool. (Long etal., 1981) Secretory diarrhea might be associated with altered motor&#xD;
      functions induced by the hormone or transmitter produced by the tumor, as in carcinoid&#xD;
      diarrhea. (Von etal., 1993) The typical features of secretory diarrhea include the&#xD;
      persistence of the diarrhea with fasting and the absence of steatorrhea, hypokalemia and&#xD;
      acidosis typically suggest VIPoma syndrome (Camilleri etal., 1982)&#xD;
&#xD;
      In motility related diarrhea, Motility disorders cause diarrhea by either accelerating&#xD;
      gastrointestinal transit (e.g., post vagotomy diarrhea) or by slowing transit, thereby&#xD;
      predisposing to small intestinal bacterial overgrowth (SIBO) (e.g., scleroderma).The most&#xD;
      prevalent forms of motility-related diarrheas is IBS-D, Rapid small-bowel transit is a&#xD;
      relatively common finding in patients with diabetes or autonomic neuropathies, or patients&#xD;
      who have undergone upper gastrointestinal tract surgery. (Posserud etal., 2007)&#xD;
&#xD;
      In Inflammatory diarrhea occurs when there is damage to the mucosal lining or brush border,&#xD;
      which leads to a passive loss of protein-rich fluids and a decreased ability to absorb these&#xD;
      lost fluids. It can be caused by bacterial infections, viral infections, parasitic&#xD;
      infections, or autoimmune problems. It can also be caused by tuberculosis, colon cancer, and&#xD;
      enteritis (Camilleri etal., 2014)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 22, 2017</start_date>
  <completion_date type="Anticipated">August 22, 2018</completion_date>
  <primary_completion_date type="Actual">August 22, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Identify the prevalence of chronic diarrhea at Gastroenterology unit at Assuit University Children Hospital</measure>
    <time_frame>one year</time_frame>
    <description>Not yet recruiting: Participants are not yet being recruited</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>improve hospital to meet the most common couse of diarrha in our hospital</measure>
    <time_frame>one year</time_frame>
    <description>Not yet recruiting: Participants are not yet being recruited</description>
  </secondary_outcome>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Chronic Diarrhea</condition>
  <eligibility>
    <study_pop>
      <textblock>
        epidemiological study&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1. -all patient from 1 month up to 17 years (1month-17 year) admitted gastroenterology&#xD;
             unit at Assuit University Children Hospital 2. Diarrhea 14 days or more ( ≥14 day)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  1. age less than 1 month (≤1 month) 2. diarrhea less than 14 days (≤14 day) 3. chronic&#xD;
             diarrhea due to malignancy &amp; chemotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>17 Years</maximum_age>
  </eligibility>
  <overall_contact>
    <last_name>moustafa abd ellatif</last_name>
    <phone>0127706049</phone>
    <email>drtifa1990@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Moustafa Abd Ellatif</name>
      <address>
        <city>Assiut</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>August 23, 2017</last_update_submitted>
  <last_update_submitted_qc>August 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>moustafa abd ellatif</investigator_full_name>
    <investigator_title>director clinical research</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03261297
org study id: 17100287
nct id: NCT03261297
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.

        -  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)
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)
observational model: Cohort
time perspective: Prospective
measure: Identify the prevalence of chronic diarrhea at Gastroenterology unit at Assuit University Children Hospital
time frame: one year
description: Not yet recruiting: Participants are not yet being recruited
measure: improve hospital to meet the most common couse of diarrha in our hospital
time frame: one year
description: Not yet recruiting: Participants are not yet being recruited
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 17 Years
last name: moustafa abd ellatif
phone: 0127706049
email: drtifa1990@gmail.com
facility: 
status: Recruiting
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: moustafa abd ellatif
investigator title: director clinical research
mesh term: Diarrhea