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Terminated Phase 4 Interventional

The Role of Synbiotics in Reducing Post-Operative Infections in Patients Undergoing Cardiac Surgery: A Pilot Study

ClinicalTrials.gov ID: NCT00164099

Public ClinicalTrials.gov record NCT00164099. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 5, 2026, 11:53 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

All surgical procedures carry with them the risk of infection. Even a minor infection can extend the hospitalization after cardiac surgery. The average minimum increase in length of stay for a single infection is three days. One of the many means used to reduce post-operative infections is the preventative, or "prophylactic", administration of antibiotics just before and just after surgery. Because antibiotics, and for that matter surgery itself, alter the body's natural immune and inflammatory responses and the makeup of the bacteria in the intestine, there is a great deal of scientific interest in using the supplementation of bacteria that naturally reside in the intestine. It is felt that by doing so, the alterations in the immune response may be corrected and the patient better able to fight infections. There are studies using probiotics that have demonstrated a reduction in infection rates in patients undergoing abdominal surgery. Subjects will be patients at high risk for infection including those with any one or more of the following characteristics: over 65 years old, poor heart function (ejection fraction \<40), diabetes (insulin dependant or non-insulin dependant), peripheral vascular disease, kidney dysfunction (creatinine level \>2mg/dl), obesity (body surface area \> 2 m2), low serum protein levels (albumin \< 2.5 mg/dl), infection of the heart valve (endocarditis), or on any antibiotics other than standard prophylaxis before surgery. The safety of these products has been very well established. Patients who consent to enter the study will receive the synbiotic mix, or a placebo, which comes in a powder that may be mixed with a drink, or washed down into the stomach through the NG tube if the patient is still on a ventilator. Dosing will be initiated within four hours of patient arrival in the Cardiac Surgery Intensive Care Unit and will continue on a twice daily basis for the duration of their admission days. Infection and diarrhea data will be monitored.

Study identification

NCT ID
NCT00164099
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 4
Lead sponsor
Beth Israel Medical Center
Other
Enrollment
40 participants

Conditions and interventions

Eligibility (public fields only)

Age range
Not listed
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 31, 2005
Primary completion
Not listed
Completion
May 31, 2007
Last update posted
Oct 31, 2007

2005 – 2007

United States locations

U.S. sites
1
U.S. states
1
U.S. cities
1
Facility City State ZIP Site status
Beth Israel Medical Center New York New York 10003

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00164099, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 31, 2007 · Synced Sep 5, 2026

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