A Pilot Study of Fecal Microbiome and Neutrophil Cellular Adhesion Molecules in Patients With Sickle Cell Disease (SCD)

NCT03007849 | Unknown

• 1 other identifier: 021316
• Study Type: observational
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients with sickle cell disease often develop painful crisis without any obvious reasons. Some patients are more likely to develop this complication than others. It is now clear that painful crisis only occurs when sickled red blood cells stick to white blood cells that have been activated, usually by inflammation or infections. A recent study in mice with sickle cell disease showed that the use of long term antibiotics could reduce the number of activated white blood cells and reduce death of the mice during sickle cell crisis. The investigators believe that sickle cell patients who develop frequent painful crisis may have a different pattern of bacteria in their intestine when compared to those whose painful crisis occurs infrequently. In this study, the investigators propose to study sickle cell subject's blood to determine how many activated white blood cells he/she have. The investigators will also examine his/her stool to compare the bacteria in his/her stool to those other sickle cell patients. The investigators will then investigate whether or not the results from the blood and stool tests correlate with how frequently the patient develops painful crisis. The investigators will examine the patients' medical records to find out how many times they have been admitted to the hospital for sickle cell crisis in the last 12 months. The investigators will also obtain information on the following: their age, their sex, whether they are taking hydroxyurea or Penicillin, when they last had a transfusion or exchange transfusion therapy and painful crisis needing hospital admission, whether they have received any antibiotics (other than Penicillin) in the last 4 weeks, and whether they are experiencing a painful crisis at the time that they enter the study. The investigators will obtain, from their previous laboratory results, their levels of hemoglobin F and markers of inflammation. The investigators will check their hemoglobin F level if they have not already had this tested. The investigators expect to enroll 50 subjects into this study at Rhode Island Hospital/Hasbro Children's Hospital.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Fecal microbiome

  1 year

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with SCD attending the hematology clinic at Rhode Island Hospital will be invited to participate in this study. A total of 50 eligible patients will be accrued to the study. Participation in the study is voluntary and the subject will not receive any compensation.

You may qualify if:

• Both male and female will be accrued to the study, without any pre-specified sex ratio.
• Subject must have either HbSS or HbS/beta thal.
• Subject is \>8 years of age; if subject is \<18 years, parental consent is needed.
• Understands the process of and is willing to provide a written consent.

You may not qualify if:

• Is taking immunosuppressive agents, including corticosteroids with prednisone at a dose of \> 30 mg/day or other forms of corticosteroid at the equivalent dose.
• Has taken systemic antimicrobials (except prophylactic Penicillin) in the preceding two weeks.
• Has had a vaso-occlusive crisis in the preceding two weeks.
• Has a history of colon cancer or an inflammatory bowel disease.
• Has a history of clostridium difficile infection in the preceding eight weeks.
• History of psychiatric disorder which in the investigators opinion may compromise compliance with the protocol or which does not allow for appropriate informed consent.
• Pregnant or lactating females.
• Patients who are court-mandated to reside at a treatment facility (e.g., drug or psychiatric treatment) or prison.

Sponsors & Collaborators

• Rhode Island Hospital: lead

Biospecimen

Retention: SAMPLES WITH DNA

Stool and blood

MeSH Terms

Conditions

Anemia, Sickle Cell

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Nicholas Hebda, BA

CONTACT

nhebda@lifespan.org

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DIRECTOR OF HEMATOLOGY

Study Record Dates

• First Submitted: December 29, 2016
• First Posted: January 2, 2017
• Study Start: January 1, 2017
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: January 4, 2017

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will not share