Status:
COMPLETED
Probiotic Ingestion and Isoagglutinin Titers
Lead Sponsor:
National Institutes of Health Clinical Center (CC)
Conditions:
Isoagglutinin-Mediated Hemolysis
Probiotic Toxicity
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
Background: * Probiotics are oral food supplements containing live bacteria that may be beneficial to a person s digestion or general health. Probiotics are available as tablets, powder, or liquid su...
Detailed Description
Probiotics are over-the-counter dietary supplements which contain live bacteria. These bacteria are normally present in the gastrointestinal tract and may provide health benefits when added to a regul...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Subjects must be healthy
- Subjects must be greater than or equal to 18 and less than or equal to 70 years of age
- Subjects must have an ABC blood group of A, B or O
- Laboratory values within established guidelines for participation in clinical studies:
- AST/ALT less than or equal to 2 times ULN; creatinine less than or equal to ULN; hemoglobin greater than or equal to 12.5 g/dL (males and females)
- Subjects must be willing to sign consent to participate in the protocol
- EXCLUSION CRITERIA:
- ABO blood group of AB
- Current apheresis platelet donor in the NIH DTM
- Current or past history of gastrointestinal disease or surgery including: Crohn s disease, ulcerative colitis, celiac disease, irritable bowel syndrome, gastric bypass or banding, esophagectomy, gastrectomy, small bowel resection, colectomy, and any history of gastrointestinal malignancy including pancreatic carcinoma
- Vaccination within the last 2 months, with the exception of the influenza vaccine
- A history of high risk behaviors for exposure to HIV, HBV, HCV, HTLV (no intravenous drug use in past 5 years, no male sex with males in last 5 years)
- Confirmed positive test result for anti-HIV-1/2, anti-HCV, anti-HTLV I/Il, anti-T.pallidum, or H BsAg.
- History of bleeding or clotting disorders
- History of hematologic malignancy
- History of inherited or acquired immune deficiency
- Diabetes mellitus (type I or II)
- Women of child-bearing potential
- I) Subjects currently taking immunosuppressive medications
- m) Subjects who have taken probiotic supplements within the last 12 months
Exclusion
Key Trial Info
Start Date :
April 28 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00891787
Start Date
April 28 2009
End Date
April 6 2011
Last Update
October 6 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892