Clinical Trial: Field Studies of Amebiasis in Bangladesh

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Field Studies of Human Immunity to Amebiasis in Bangladesh: A Prospective Study of Children Ages 0-17 Years

Brief Summary: The purpose of this study will be to investigate the incidence of both Amebiasis and cryptosporidiosis in Bangladeshi children and examine genetic variation in innate and adaptive immunity with respect to these infections. Novel diagnostics to these infections will also be investigated.

Detailed Summary:

Entamoeba histolytica infection results from ingestion of the cyst of Entamoeba histolytica from fecally-contaminated food or water. Local invasion results in amebic dysentery and metastasis to amebic liver abscess. The diagnosis of intestinal amebiasis is ideally made using an E. histolytica-specific stool antigen detection test or using real-time polymerase chain reaction (PCR). The two major clinical syndromes of amebiasis are amebic colitis and amebic liver abscess. Together they are estimated to result in 50 million cases of colitis and liver abscess and 100,000 deaths worldwide each year. In developing countries, colonization with E. histolytica has been observed in 5% or more of poor children. Patients with amebic colitis typically present with a several week history of gradual onset of abdominal pain and tenderness, diarrhea and bloody stools (dysentery). The pathological lesions in the colon include ulceration of the intestinal epithelium and invasion into the lamina propria by trophozoites. Inflammation, with infiltrating neutrophils and mononuclear lymphocytes is pronounced, but inflammatory cells near the amebae are killed with pyknotic nuclei characteristic of apoptotic death. Amebic liver abscess is a rare form of the disease that is almost exclusively limited to adult males.

Cryptosporidiosis in humans is caused primarily by two species, Cryptosporidium parvum and C. hominis. There are annually approximately 1.4 cases/100,000 in the United States reported to the Centers for Disease Control. Infection results from ingestion of fecally contaminated water or food containing the infectious oocyst form. Sporozoites are released from the oocyst in the small intestine and attach to the epithelial cell surface. Upon invasion of the epithelial cells the parasite undergoes both the sexual and asexual stages of the life cycle. Infection with C. parvum in a normal host
Sponsor: University of Virginia

Current Primary Outcome: Incidence of Amebiasis and Cryptosporidium infection [ Time Frame: Birth to 5 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Peripheral blood mononuclear cell Interleukin (IL)-1β stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-2 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-4 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-5 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-6 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-7 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-8 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-10 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-12(p70) stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-12(p40) stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-13 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagnosis of E. histolytica infection or disease.
  • Peripheral blood mononuclear cell IL-17 stimulation studies [ Time Frame: Birth to 5 years ]
    Investigators plan to obtain blood for cytokine analysis from children when they do not have E. histolytica infection and are free of diarrheal disease. Investigators also plan to obtain blood for cytokine analysis from children within 48 hours of the diagn

    Original Secondary Outcome: Same as current

    Information By: University of Virginia

    Dates:
    Date Received: March 22, 2016
    Date Started: January 2008
    Date Completion:
    Last Updated: April 5, 2016
    Last Verified: April 2016