AmebiasisNCT00001162
Parasitic Infections of the Gastrointestinal Tract
An observational study of Amebiasis and Cryptosporidiosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
This protocol offers diagnosis and standard medical treatment for various parasitic gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or one-celled animals called protozoans which live in the human intestines. Often, parasitic infections do not cause illness. Read more about this study
- Who is it for?
- Ages 3 years and older
- Conditions the study is for
- Amebiasis, Cryptosporidiosis, Giardiasis
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 1977to 31 May 2017
- 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 3 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Persons with proven or highly suspected parasitic infections involving the gastrointestinal tract (including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, cyclorsporiasis, cryptosporidia infections, microsporidia infections, isosporidium infections, trichinosis, gastrointestinal dwelling trematodes, coccdioiosis, and echinococccus and additional infections).
- Persons older than 2.
- Ability and willingness of the subject or legal guardian/representative to give written informed consent.
Who cannot join
- Subject unwilling or unable to comply with requirements of the protocol in the opinion of the investigator.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Study of Patients With Parasitic Infections of the Gastrointestinal Tract
This protocol offers diagnosis and standard medical treatment for various parasitic gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or one-celled animals called protozoans which live in the human intestines. Often, parasitic infections do not cause illness. In these cases, drug treatment is not indicated, because treatment can have adverse side effects. Patients will be examined for their immune responses, correlation between the number of parasites and disease, and other studies.
Individuals with known or suspected parasitic diseases of the gastrointestinal tract, including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be eligible for this study.
Read more
Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum (first part of the small intestine). Other tests may be required, depending on the parasite and disease. Direct examination of the tissues of the intestines may be required to rule out certain infections.
Research procedures include collection of stool, blood and duodenal fluid when the diagnosis has been established and these procedures are not required for medical care. Patients with strongyloidiasis may also be given a diagnostic skin test similar to skin tests for tuberculosis and allergies. Research procedures on children will be limited to collection of stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2 pounds) body weight of blood will be collected in children over a 6-week period. In adults no more than 30 tablespoons of blood will be collected in a 6-week period.
Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the parasite in the laboratory in order to test treatments in the test tube. Patients who do not respond to standard medications and dosing may need different doses of drugs or drugs or combinations of drugs used in the United States for other medical problems. If these medications or doses are used, patients will be informed of their possible side effects.
Read the detailed description
The precis of this protocol is to allow the evaluation, treatment and study of patients with a variety of gastrointestinal parasites. This protocol primarily allows evaluation and treatment of patients with any intestinal parasite that requires a medical evaluation. The treatment and evaluation consists of standard of care. Research aspects include the collection and study of different parasite populations, analysis of the immune responses of the host, a correlation between parasite burden in the host and disease. These patients also serve as a source of reagents such as feces, white blood cells, and serum. The off-label use of FDA approved drugs is employed to treat symptomatic giardiasis in patients who cannot be cured otherwise and to determine empirically which regimens are effective and safe.
- Conditions
- Amebiasis, Cryptosporidiosis, Giardiasis, Parasitic Disease, Parasitic Intestinal Disease, Gastrointestinal Helminth Infections
- Keywords
- Giardia, Helminth, Cryptosporidium, Hookworms, Trichuris, Strongyloides, Protozoa, Small Bowel Biopsy, E. Histolytica, Duodenal Aspiration, Coccidiosis, Clonorchis, Amebiasis, Parasitic Disease, Tapeworm, Trichinosis, Gastrointestinal Trematodes, Opisthorchis, Paragonimiasis, Echinococcus
- Medical subject headings
- Amebiasis, Cryptosporidiosis, Giardiasis, Parasitic Diseases, Intestinal Diseases, Parasitic, Hookworm Infections, Coccidiosis, Cestode Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
To Collect and study different parasite populations to study and/or axenization of specific parasites, analyze immune responses to homologous or heterologous parasites, and the development of diagnostic tests
Measured: Screening visit
Off label use of FDA approved drugs for treatment of Giardiasis in patients who cannot be cured otherwise, determining empirically which regimen is effective and safe
Measured: Post Tx follow up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start23 May 1977
- Study completion31 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmebiasisStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Theodore E Nash, M.D., Principal investigator, National Institute of Allergy and Infectious Diseases (NIAID)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001162
- Sponsor's protocol ID
- 770094
- Other IDs
- 77-I-0094
- Status last verified
- 31 May 2017
- First submitted
- 3 Nov 1999
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Kulakova L, Singer SM, Conrad J, Nash TE. Epigenetic mechanisms are involved in the control of Giardia lamblia antigenic variation. Mol Microbiol. 2006 Sep;61(6):1533-42. doi: 10.1111/j.1365-2958.2006.05345.x.
PubMed 16968226Ungar BL, Yolken RH, Nash TE, Quinn TC. Enzyme-linked immunosorbent assay for the detection of Giardia lamblia in fecal specimens. J Infect Dis. 1984 Jan;149(1):90-7. doi: 10.1093/infdis/149.1.90.
PubMed 6363569Nutman TB, Hussain R, Ottesen EA. IgE production in vitro by peripheral blood mononuclear cells of patients with parasitic helminth infections. Clin Exp Immunol. 1984 Oct;58(1):174-82.
PubMed 6478649
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Patients With Parasitic Infections of the Gastrointestinal Tract
- ClinicalTrials.gov ID
- NCT00001162
- Acronym / sponsor ID
- 770094
- Conditions
- Amebiasis, Cryptosporidiosis, Giardiasis, Parasitic Disease, Parasitic Intestinal Disease, Gastrointestinal Helminth Infections
- Keywords
- Giardia, Helminth, Cryptosporidium, Hookworms, Trichuris, Strongyloides, Protozoa, Small Bowel Biopsy
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 150 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 23 May 1977
- Study completion
- 31 May 2017
- First posted
- 4 Nov 1999 (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.
This protocol offers diagnosis and standard medical treatment for various parasitic gastrointestinal infections. Gastrointestinal parasites are either worms (helminths) or one-celled animals called protozoans which live in the human intestines. Often, parasitic infections do not cause illness. In these cases, drug treatment is not indicated, because treatment can have adverse side effects. Patients will be examined for their immune responses, correlation between the number of parasites and disease, and other studies.
Individuals with known or suspected parasitic diseases of the gastrointestinal tract, including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, trichinosis, clonorchis, opisthorchis, coccidiosis, paragonimiasis, and echinococcus may be eligible for this study.
Patient evaluations may include blood and urine tests, stool examination, X-rays, ultrasound studies and, uncommonly, duodenal aspiration for examination of fluid from the duodenum (first part of the small intestine). Other tests may be required, depending on the parasite and disease. Direct examination of the tissues of the intestines may be required to rule out certain infections.
Research procedures include collection of stool, blood and duodenal fluid when the diagnosis has been established and these procedures are not required for medical care. Patients with strongyloidiasis may also be given a diagnostic skin test similar to skin tests for tuberculosis and allergies. Research procedures on children will be limited to collection of stool, urine and blood. No more than 7 milliliters (1 1/2 teaspoons) per kilogram (2.2 pounds) body weight of blood will be collected in children over a 6-week period. In adults no more than 30 tablespoons of blood will be collected in a 6-week period.
Parasites may fail to respond to treatment. In these cases, it may be necessary to grow the parasite in the laboratory in order to test treatments in the test tube. Patients who do not respond to standard medications and dosing may need different doses of drugs or drugs or combinations of drugs used in the United States for other medical problems. If these medications or doses are used, patients will be informed of their possible side effects.
Detailed description
The precis of this protocol is to allow the evaluation, treatment and study of patients with a variety of gastrointestinal parasites. This protocol primarily allows evaluation and treatment of patients with any intestinal parasite that requires a medical evaluation. The treatment and evaluation consists of standard of care. Research aspects include the collection and study of different parasite populations, analysis of the immune responses of the host, a correlation between parasite burden in the host and disease. These patients also serve as a source of reagents such as feces, white blood cells, and serum. The off-label use of FDA approved drugs is employed to treat symptomatic giardiasis in patients who cannot be cured otherwise and to determine empirically which regimens are effective and safe.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Persons with proven or highly suspected parasitic infections involving the gastrointestinal tract (including amebiasis, giardiasis, hookworm, strongyloidiasis, trichuriasis, pinworm, tapeworm, cyclorsporiasis, cryptosporidia infections, microsporidia infections, isosporidium infections, trichinosis, gastrointestinal dwelling trematodes, coccdioiosis, and echinococccus and additional infections).
- Persons older than 2.
- Ability and willingness of the subject or legal guardian/representative to give written informed consent.
Key exclusion criteria (1 listed)
- Subject unwilling or unable to comply with requirements of the protocol in the opinion of the investigator.
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
To Collect and study different parasite populations to study and/or axenization of specific parasites, analyze immune responses to homologous or heterologous parasites, and the development of diagnostic tests
Time frame: Screening visit
Off label use of FDA approved drugs for treatment of Giardiasis in patients who cannot be cured otherwise, determining empirically which regimen is effective and safe
Time frame: Post Tx follow up visit
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 16968226Kulakova L, Singer SM, Conrad J, Nash TE. Epigenetic mechanisms are involved in the control of Giardia lamblia antigenic variation. Mol Microbiol. 2006 Sep;61(6):1533-42. doi: 10.1111/j.1365-2958.2006.05345.x.
- Background: PubMed 6363569Ungar BL, Yolken RH, Nash TE, Quinn TC. Enzyme-linked immunosorbent assay for the detection of Giardia lamblia in fecal specimens. J Infect Dis. 1984 Jan;149(1):90-7. doi: 10.1093/infdis/149.1.90.
- Background: PubMed 6478649Nutman TB, Hussain R, Ottesen EA. IgE production in vitro by peripheral blood mononuclear cells of patients with parasitic helminth infections. Clin Exp Immunol. 1984 Oct;58(1):174-82.
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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.
Theodore E Nash, M.D. principal investigator
National Institute of Allergy and Infectious Diseases (NIAID)
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 Cryptosporidiosis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
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 3 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: stopped early, as of the sponsor's last update on 2 Jul 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 United States. 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 was stopped early. Results are not available in the source record.
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?
To Collect and study different parasite populations to study and/or axenization of specific parasites, analyze immune responses to homologous or heterologous parasites, and the development of diagnostic tests (time frame: Screening visit). The study lists 2 primary outcomes in all. 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 NCT00001162, which also lists 3 linked publications.
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 2 Jul 2017.