Probiotic Ingestion and Isoagglutinin Titers

NCT00891787 | Completed Phase 1

• 2 other identifiers: 09013509-CC-0135
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Isoagglutinin-Mediated Hemolysis; Probiotic Toxicity

Keywords

Probiotics; Isoagglutinins; Anti-A; Anti-B; Hemolysis; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (1)

• Changes in isoagglutinin titer

Secondary Outcomes (1)

• Dose-response relationship between probiotic dose and peak change in isoagglutinin titer.

Interventions

Probiotic Supplement DIETARY_SUPPLEMENT

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Snelling AM. Effects of probiotics on the gastrointestinal tract. Curr Opin Infect Dis. 2005 Oct;18(5):420-6. doi: 10.1097/01.qco.0000182103.32504.e3.

  PMID: 16148529 BACKGROUND

• 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. doi: 10.1084/jem.110.2.221.

  PMID: 13673136 BACKGROUND

• 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. doi: 10.1159/000427094. No abstract available.

  PMID: 13499259 BACKGROUND

MeSH Terms

Conditions

Hemolysis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Susan F Leitman, M.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 30, 2009
• First Posted: May 1, 2009
• Study Start: April 28, 2009
• Primary Completion: April 6, 2011
• Study Completion: April 6, 2011
• Last Updated: October 6, 2017

Record last verified: 2014-04-10

Locations

US (1)