Protocol Number: 09-CC-0135

Title:

Probiotic Ingestion and Isoagglutinin Titers

Number:

09-CC-0135

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 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.

Sponsoring Institute:

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

a) Subjects must be healthy

b) Subjects must be greater than or equal to 18 and less than or equal to 70 years of age

c) Subjects must have an ABC blood group of A, B or O

d) 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)

e) Subjects must be willing to sign consent to participate in the protocol

EXCLUSION CRITERIA:

a) ABO blood group of AB

b) Current apheresis platelet donor in the NIH DTM

c) 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

d) Vaccination within the last 2 months, with the exception of the influenza vaccine

e) 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)

f) Confirmed positive test result for anti-HIV-1/2, anti-HCV, anti-HTLV I/Il, anti-T.pallidum, or H BsAg.

g) History of bleeding or clotting disorders

h) History of hematologic malignancy

i) History of inherited or acquired immune deficiency

j) Diabetes mellitus (type I or II)

k) Women of child-bearing potential

I) Subjects currently taking immunosuppressive medications

m) Subjects who have taken probiotic supplements within the last 12 months

Special Instructions:

Currently Not Provided

Keywords:

Probiotics

Isoagglutinins

Anti-A

Anti-B

Hemolysis

Recruitment Keyword(s):

Healthy Volunteer

HV

Condition(s):

Isoagglutinin-Mediated Hemolysis

Probiotic Toxicity

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Dietary Supplement: Probiotic Supplement

Supporting Site:

Warren G. Magnuson Clinical Center

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Snelling AM. Effects of probiotics on the gastrointestinal tract. Curr Opin Infect Dis. 2005 Oct;18(5):420-6.

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.

Springer GF, Pringer 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.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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