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NCT00891787 · ClinicalTrials.gov registry record · Phase 1
Probiotic Ingestion and Isoagglutinin Titers
A Phase 1 study, sponsored by National Institutes of Health Clinical Center (CC).
- Completed
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
NCT00891787 is a Phase 1 study that has completed, run by National Institutes of Health Clinical Center (CC). The registered enrollment target is 36 participants.
The verdict
NCT00891787, a Phase 1 study, has completed, sponsored by National Institutes of Health Clinical Center (CC).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
Study 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 t
Interventions
- DIETARY_SUPPLEMENT Probiotic Supplement
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2009-04-28 |
| Est. Completion | 2011-04-06 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00891787
The ClinicalTrials.gov registry entry for NCT00891787 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institutes of Health Clinical Center (CC), which has 338 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Probiotic Supplement is the first listed.
NCT00891787 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00891787 about?
NCT00891787 is a clinical study titled "Probiotic Ingestion and Isoagglutinin Titers". 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 pres...
What is the current status of trial NCT00891787?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2009-04-28. Estimated completion is 2011-04-06.
What interventions are being tested in trial NCT00891787?
The interventions under investigation include: Probiotic Supplement (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT00891787?
This trial is sponsored by National Institutes of Health Clinical Center (CC), which has 338 total clinical trials registered on ClinicalTrials.gov.
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