Isoagglutinin-Mediated Hemolysis Clinical Trial
Official title:
Probiotic Ingestion and Isoagglutinin Titers
| Verified date | April 10, 2014 |
| Source | National Institutes of Health Clinical Center (CC) |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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 supplements and are frequently used to supplement yogurt. They are available for
purchase without prescription in most supermarkets.
- The bacteria in probiotic supplements commonly express sugar substances on their
surface. These sugar substances are similar to group A and B blood group sugars, called
antigens. These antigens determine a person s blood group. Researchers are studying the
effect of probiotic supplements on the amount of blood group antibodies that are present
in a person s blood.
Objectives:
- To determine whether taking oral probiotic supplements increases anti-A and anti-B
isoagglutinins (antibodies that cause red blood cells to clump together) in healthy
subjects.
- To study the frequency of these effects and determine whether there is a dose-response
relationship with probiotics and isoagglutinin titers.
Eligibility:
- Healthy adults, 18 years or older, with type A, B, or O blood.
- Female participants need to have undergone menopause or have had a hysterectomy.
- Individuals are ineligible if they currently donate platelets; have a history of
ulcerative colitis or Crohn s disease; have had major bowel surgery; are pregnant or
capable of becoming pregnant; have a bleeding or clotting disorder; have a history of a
blood disorder or immune deficiency; have a history of high-risk behaviors for exposure
to HIV or hepatitis B or C; have diabetes; have received vaccinations in the past 2
months, with the exception of the flu vaccine; are currently taking immunosuppressive
medications; are currently taking antibiotics; or have taken probiotic supplements
within the last 12 months.
Design:
- Researchers will conduct the following tests throughout the 28-week study:
- Blood samples will be drawn every 2 weeks to measure the quantity of isoagglutinin
titers.
- Depending on individual results, continued blood testing may be done every 3 months
for 1 year, then every 6 to 12 months for up to 5 years.
- Study subjects will take a probiotic supplement at a dose of 1 to 3 caplets per day for
18 consecutive weeks according to the following schedule:
- During the first 6-week period, the subject will take one probiotic tablet daily.
- During the second 6-week period, the subject will take one probiotic tablet twice
daily.
- During the third 6-week period, the subject will take one probiotic tablet three
times daily.
- Control group subjects will be followed in a similar manner but will not take probiotic
supplements.
- The outcome measure is the percent of probiotic ingestors (the study subjects) versus
control group subjects who experience a fourfold or greater rise in isoagglutinin titer.
- Study subjects will receive the following financial compensation: $10 per blood sample,
for a maximum of $240 if all 24 samples are collected; $100 after completing the first
6-week period; $150 after completing the second 6-week period; and $200 after completing
the third 6-week period.
- Control subjects will receive $10 per blood sample, for a maximum of $150 if all 15
samples are collected.
| Status | Completed |
| Enrollment | 36 |
| Est. completion date | April 6, 2011 |
| Est. primary completion date | April 6, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 70 Years |
| Eligibility |
- INCLUSION CRITERIA: 1. Subjects must be healthy 2. Subjects must be greater than or equal to 18 and less than or equal to 70 years of age 3. Subjects must have an ABC blood group of A, B or O 4. 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) 5. Subjects must be willing to sign consent to participate in the protocol EXCLUSION CRITERIA: 1. ABO blood group of AB 2. Current apheresis platelet donor in the NIH DTM 3. 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 4. Vaccination within the last 2 months, with the exception of the influenza vaccine 5. 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) 6. Confirmed positive test result for anti-HIV-1/2, anti-HCV, anti-HTLV I/Il, anti-T.pallidum, or H BsAg. 7. History of bleeding or clotting disorders 8. History of hematologic malignancy 9. History of inherited or acquired immune deficiency 10. Diabetes mellitus (type I or II) 11. Women of child-bearing potential I) Subjects currently taking immunosuppressive medications m) Subjects who have taken probiotic supplements within the last 12 months |
| Country | Name | City | State |
|---|---|---|---|
| United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
| Lead Sponsor | Collaborator |
|---|---|
| National Institutes of Health Clinical Center (CC) |
United States,
Snelling AM. Effects of probiotics on the gastrointestinal tract. Curr Opin Infect Dis. 2005 Oct;18(5):420-6. Review. — View Citation
SPRINGER GF, ANSELL N, BRANDES W, NORRIS RF. Relation of blood group specific substances from bacilli and a higher plant to hemagglutinin formation. Bibl Haematol. 1958;7:190-5. — View Citation
SPRINGER GF, HORTON RE, FORBES M. [Origin of anti-human blood group B agglutinins in white Leghorn chicks]. J Exp Med. 1959 Aug 1;110(2):221-44. Undetermined Language. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Changes in isoagglutinin titer | |||
| Secondary | Dose-response relationship between probiotic dose and peak change in isoagglutinin titer. |