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Clinical trialNCT00891787CompletedPhase 1Interventional

Probiotic Ingestion and Isoagglutinin Titers

SponsorNational Institutes of Health Clinical Center (CC)Enrollment36Isoagglutinin-Mediated HemolysisProbiotic Toxicity
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Susan F Leitman, M.D.

    National Institutes of Health Clinical Center (CC)

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
28 Apr 2009
Primary completion
6 Apr 2011
Completion
6 Apr 2011
Last update posted
6 Oct 2017
Registered enrollment
36
Registry id
NCT00891787

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.