AmebiasisNCT02734264
Field Studies of Amebiasis in Bangladesh
An observational study of Amebiasis and Cryptosporidium, run by University of Virginia at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Amebiasis, Cryptosporidium
- How many people
- 629 participants
- Where
- 1 siteBangladesh
- Study dates
- Jan 2008to Dec 2014
- 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 Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: Newborn children in the Mirpur neighborhood of Dhaka, Bangladesh.
Who may be able to join
- Resident of Mirpur, Dhaka, Bangladesh
Who cannot join
- Mother under 65 years old
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
The International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka
About this study
Official title: Field Studies of Human Immunity to Amebiasis in Bangladesh: A Prospective Study of Children Ages 0-17 Years
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.
Read the detailed description
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 leads to days to several weeks of non-bloody diarrhea.
In many people E. histolytica and Cryptosporidia infections resolve without symptoms. A major emphasis of this study will be to study the host, environment, and parasite factors controlling susceptibility to E. histolytica and Cryptosporidia infection and disease, to begin to answer the question of why all infections do not cause disease. At the same time, want to improve diagnostic techniques for these diseases.
This study will continue a cohort of 420 children (average age now 10.5 years) that the research team has been following since birth and measure the incidence of amebiasis and cryptosporidiosis prospectively. In addition, 500 live births will be enrolled into an existing cohort.
This work has several objectives. The first objective is to compare current "gold-standard" diagnostic techniques for these diseases with newer antigen detection and polymerase chain reaction techniques. The second objective is to delineate the protective role of innate and acquired immunity to E. histolytica. The investigators hypothesize that protective immunity is mediated both by innate immune responses initiated via Toll-like Receptor stimulation and acquired responses including mucosal immunoglobulin A (IgA) and systemic Interferon-γ. Acquired immune responses (peripheral blood mononuclear cell cytokine production and fecal IgA anti-cross reacting determinant) during amebic and cryptosporidial infection and disease will be determined in the children in the cohort. The third objective is to test for the association of genetic polymorphisms in innate and acquired immune genes with incidence of amebiasis. The investigators hypothesize that common genetic polymorphisms in genes of the innate and acquired immune system influence susceptibility to E. histolytica and Cryptosporidia infection or disease. The final objective is to test the role of human genetic polymorphisms and microbiome in protection from undernutrition. Genome wide scans and microbiome compositional analyses will be performed on children to determine if the nutritional status of the child correlates with these measurements.
- Conditions
- Amebiasis, Cryptosporidium
- Medical subject headings
- Amebiasis
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Amebiasis and Cryptosporidium infection
Measured: Birth to 5 years
Secondary outcomes (35)
Peripheral blood mononuclear cell Interleukin (IL)-1β stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-2 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-4 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-5 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-6 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-7 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-8 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-10 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-12(p70) stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-12(p40) stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-13 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell IL-17 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell interferon-γ stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell granulocyte-macrophage colony-stimulating factor stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell tumor necrosis factor-α stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell tumor necrosis factor-β stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell granulocyte-colony stimulating factor stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell macrophage inflammatory protein (MIP)-1 β stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell MIP-1 α stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell monocyte chemotactic protein-1 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell eotaxin stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell fibroblast growth factor basic stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell vascular endothelial growth factor stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell "regulated on activation, normal T expressed and secreted" (RANTES) stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell leptin stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell epithelial neutrophil activating peptide (ENA)-78 stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell nerve growth factor stimulation studies
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.
Measured: Birth to 5 years
Peripheral blood mononuclear cell inducible protein-10 stimulation studies
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.
Measured: Birth to 5 years
Fecal immunoglobulin-A
This will be collected as paired samples. One sample will be from each episode of Amebiasis diarrhea and will paired with a stool from that child when they have no Amebiasis detected in the stool and are without acute diarrhea.
Measured: Birth to 5 years
Fecal immunoglobulin-G anti-cross-reacting determinant
This will be collected as paired samples. One sample will be from each episode of Amebiasis diarrhea and will paired with a stool from that child when they have no Amebiasis detected in the stool and are without acute diarrhea.
Measured: Birth to 5 years
Single nucleotide polymorphism analysis of innate and adaptive immunity
Measured: Once; between birth and day 7 of life.
Genome wide association scan
Measured: Once, at 5 years of age
Fecal microbiome determination via 16s ribosomal deoxyribonucleic acid (rDNA)
Measured: Birth to 5 years
Length/Height in centimeters
Measured: Birth to 5 years
Weight in grams
Measured: Birth to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2016 (estimated)
- Study startJan 2008
- Primary completionDec 2014
- Study completionDec 2014
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 AmebiasisStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 629 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Principal investigator, William Petri, MD, University of Virginia
- Investigators
- William A Petri, M.D., PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02734264
- Sponsor's protocol ID
- 7563
- Status last verified
- Apr 2016
- First submitted
- 22 Mar 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Zhang Y, Zhou J, Niu F, Donowitz JR, Haque R, Petri WA Jr, Ma JZ. Characterizing early child growth patterns of height-for-age in an urban slum cohort of Bangladesh with functional principal component analysis. BMC Pediatr. 2017 Mar 21;17(1):84. doi: 10.1186/s12887-017-0831-y.
PubMed 28327104
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Field Studies of Human Immunity to Amebiasis in Bangladesh: A Prospective Study of Children Ages 0-17 Years
- ClinicalTrials.gov ID
- NCT02734264
- Acronym / sponsor ID
- 7563
- Conditions
- Amebiasis, Cryptosporidium
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 629 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- Jan 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 12 Apr 2016 (estimated)
- 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.
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 description
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 leads to days to several weeks of non-bloody diarrhea.
In many people E. histolytica and Cryptosporidia infections resolve without symptoms. A major emphasis of this study will be to study the host, environment, and parasite factors controlling susceptibility to E. histolytica and Cryptosporidia infection and disease, to begin to answer the question of why all infections do not cause disease. At the same time, want to improve diagnostic techniques for these diseases.
This study will continue a cohort of 420 children (average age now 10.5 years) that the research team has been following since birth and measure the incidence of amebiasis and cryptosporidiosis prospectively. In addition, 500 live births will be enrolled into an existing cohort.
This work has several objectives. The first objective is to compare current "gold-standard" diagnostic techniques for these diseases with newer antigen detection and polymerase chain reaction techniques. The second objective is to delineate the protective role of innate and acquired immunity to E. histolytica. The investigators hypothesize that protective immunity is mediated both by innate immune responses initiated via Toll-like Receptor stimulation and acquired responses including mucosal immunoglobulin A (IgA) and systemic Interferon-γ. Acquired immune responses (peripheral blood mononuclear cell cytokine production and fecal IgA anti-cross reacting determinant) during amebic and cryptosporidial infection and disease will be determined in the children in the cohort. The third objective is to test for the association of genetic polymorphisms in innate and acquired immune genes with incidence of amebiasis. The investigators hypothesize that common genetic polymorphisms in genes of the innate and acquired immune system influence susceptibility to E. histolytica and Cryptosporidia infection or disease. The final objective is to test the role of human genetic polymorphisms and microbiome in protection from undernutrition. Genome wide scans and microbiome compositional analyses will be performed on children to determine if the nutritional status of the child correlates with these measurements.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Newborn children in the Mirpur neighborhood of Dhaka, Bangladesh.
Key inclusion criteria (1 listed)
- Resident of Mirpur, Dhaka, Bangladesh
Key exclusion criteria (1 listed)
- Mother under 65 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Amebiasis and Cryptosporidium infection
Time frame: Birth to 5 years
35 secondary outcomes
Peripheral blood mononuclear cell Interleukin (IL)-1β stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-2 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-4 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-5 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-6 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-7 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-8 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-10 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-12(p70) stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-12(p40) stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-13 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell IL-17 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell interferon-γ stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell granulocyte-macrophage colony-stimulating factor stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell tumor necrosis factor-α stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell tumor necrosis factor-β stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell granulocyte-colony stimulating factor stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell macrophage inflammatory protein (MIP)-1 β stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell MIP-1 α stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell monocyte chemotactic protein-1 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell eotaxin stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell fibroblast growth factor basic stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell vascular endothelial growth factor stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell "regulated on activation, normal T expressed and secreted" (RANTES) stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell leptin stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell epithelial neutrophil activating peptide (ENA)-78 stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell nerve growth factor stimulation studies
Time frame: Birth to 5 years
Peripheral blood mononuclear cell inducible protein-10 stimulation studies
Time frame: Birth to 5 years
Fecal immunoglobulin-A
Time frame: Birth to 5 years
Fecal immunoglobulin-G anti-cross-reacting determinant
Time frame: Birth to 5 years
Single nucleotide polymorphism analysis of innate and adaptive immunity
Time frame: Once; between birth and day 7 of life.
Genome wide association scan
Time frame: Once, at 5 years of age
Fecal microbiome determination via 16s ribosomal deoxyribonucleic acid (rDNA)
Time frame: Birth to 5 years
Length/Height in centimeters
Time frame: Birth to 5 years
Weight in grams
Time frame: Birth to 5 years
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 26 Oct 2017.
- Derived from this study: PubMed 28327104Zhang Y, Zhou J, Niu F, Donowitz JR, Haque R, Petri WA Jr, Ma JZ. Characterizing early child growth patterns of height-for-age in an urban slum cohort of Bangladesh with functional principal component analysis. BMC Pediatr. 2017 Mar 21;17(1):84. doi: 10.1186/s12887-017-0831-y.
- Individual participant dataSharing planned: Undecided
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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.
William A Petri, M.D., PhD principal investigator
University of Virginia
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 Amebiasis and Cryptosporidium, run by University of Virginia at 1 site in Bangladesh.
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: finished, as of the sponsor's last update on 26 Oct 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 Bangladesh. 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?
Incidence of Amebiasis and Cryptosporidium infection (time frame: Birth to 5 years). 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 NCT02734264, 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 26 Oct 2017.