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Hookworm Immune Regulation Project (HIRP-01)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Université Libre de Bruxelles
Information provided by (Responsible Party):
Olivier Michel, Brugmann University Hospital
ClinicalTrials.gov Identifier:
NCT02262403
First received: September 16, 2014
Last updated: July 25, 2016
Last verified: July 2016
  Purpose
The main objective of this study is to characterize the regulatory immune response induced by hookworm in an infected Vietnamese rural population from the periphery of HCM, evolution after infection treatment and during potential naturally reinfection.

Condition Intervention
Hookworm Infection Other: Blood and feces sampling

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: Study of Immuno-regulatory Mechanisms Induced by Hookworm Infection

Resource links provided by NLM:


Further study details as provided by Olivier Michel, Brugmann University Hospital:

Primary Outcome Measures:
  • Amount and phenotype of Treg [ Time Frame: 0-12 weeks ]
    Four colors flow cytometry Treg measurements and phenotyping (FACSCantoII).


Other Outcome Measures:
  • PBMC culture and cryopreservation [ Time Frame: after 12 weeks ]
    Assessment of the orientation of the adaptative immune response to Dermatophagoides pteronyssinus.Subsequent Treg function testing and cell cultures (with environmental antigen) on cryopreserved PBMC (Peripheral Blood Mononuclear cells).


Enrollment: 40
Study Start Date: August 2014
Estimated Study Completion Date: March 2017
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hookworm infected
The amount, phenotype and function of Treg will be explored at several time points. Cultures with environmental antigen will be subsequently performed.
Other: Blood and feces sampling
Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.
Active Comparator: Non infected (hookworms) healthy subjects
All the tests done in the experimental hookworm infected group will be also done in the comparator non infected group.
Other: Blood and feces sampling
Blood and feces samples will be examined after 14 days, 28 days, 3 months and 16 months. This will require blood and feces sampling. The study is therefore defined as 'interventional' rather than 'observational' as it includes acts outside the standard of care.

Detailed Description:

Population: 20 healthy adults (18-65 years) infected and non infected by Hookworm will be recruited and treated according to Good Clinical Practice recommendations.

Allergy will be excluded by skin prick tests. Amount and phenotype of Treg will be explored at several time points. Subsequent culture with environmental antigen will be performed on cryopreserved cells.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18-65 years old adults in good health status
  • To live in rural regions at risk of soil transmitted helminthes
  • Hookworm infection (infected group)
  • Uninfected by Hookworms (control group)

Exclusion Criteria:

  • Pregnant woman
  • Positive allergic history
  • Auto-immune and/or HIV disease
  • Antihelminthics drug in the last 6 months and other current parasitic infection
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02262403

Locations
Vietnam
Pham Ngoc Thach University of Medecine
Ho Chi Minh City, Distict 10, Vietnam
Sponsors and Collaborators
Brugmann University Hospital
Université Libre de Bruxelles
Investigators
Principal Investigator: Virginie Doyen, MD CHU Brugmann - ULB
  More Information

Publications:
Responsible Party: Olivier Michel, Head of clinic, Brugmann University Hospital
ClinicalTrials.gov Identifier: NCT02262403     History of Changes
Other Study ID Numbers: CHUB-HIRP-01
Study First Received: September 16, 2014
Last Updated: July 25, 2016

Keywords provided by Olivier Michel, Brugmann University Hospital:
Hookworm
Helminths
Treg
Immune regulation
Vietnam
Allergic diseases

Additional relevant MeSH terms:
Infection
Hookworm Infections
Ancylostomiasis
Strongylida Infections
Secernentea Infections
Nematode Infections
Helminthiasis
Parasitic Diseases

ClinicalTrials.gov processed this record on June 23, 2017