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Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00364650
Recruitment Status : Completed
First Posted : August 15, 2006
Last Update Posted : July 26, 2011
Hoffmann-La Roche
Information provided by:
Swedish Medical Center

Brief Summary:
We hypothesize that the administration of a combination of high numbers of probiotic bacteria will maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation.

Condition or disease Intervention/treatment Phase
Immunosuppressant Associated Diarrhea Drug: Probiotic Supplement Other: Placebo Not Applicable

Detailed Description:

Immunosuppression following organ transplantation is associated with a myriad of gastrointestinal complications including severe diarrhea. Mycophenolate mofetil (MMF) is the immunosuppressant most often associated with this plaguing symptom. A retrospective study of patients from 10 US transplant centers receiving MMF immunosuppression after kidney transplantation showed that nearly 50% of patients suffered from at least one gastrointestinal symptom within the first 6 months after transplantation. (Tierce 2005) The majority of these patients have diarrhea. However, Immunosuppression Associated Diarrhea (IAD) is often observed in association with other immunosuppressive agents as well. It is the investigator's observation that IAD is equally problematic whether the immunosuppressive regimen includes MMF or not. When IAD is severe it can be difficult for the recipient to maintain adequate levels of immunosuppression. Not infrequently, IAD is so distressing that a recipient's immunosuppressive medications are tapered, changed or stopped. During these times of drug manipulation, patients are at risk for early acute rejection. Approximately 30% of renal transplant patients who have their MMF regimen adjusted or discontinued suffer an episode of acute rejection. Reversing a rejection episode is expensive and adds significant risks for the recipient and long-term allograft survival. Thus, a strategy to support and maintain normal healthy bowel function moderating or obviating IAD is highly desirable.

Repopulation of the normal intestinal microflora in kidney transplant patients after kidney transplantation may maintain normal bowel function. This study is designed to test the hypothesis that the administration of a food supplement probiotic consisting of high amounts of six strains of lactic acid bacteria normally found in the human colon will favorably support and maintain bowel function moderating or obviating IAD.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation: a Single Center Randomized Controlled Trial
Study Start Date : July 2006
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Placebo Comparator: I
Other: Placebo

Experimental: II
Probiotic supplement
Drug: Probiotic Supplement
2 capsules twice daily

Primary Outcome Measures :
  1. To maintain normal bowel function and significantly moderate or obviate Immunosuppression Associated Diarrhea following kidney transplantation, utilizing a daily questionnaire, stool cultures and C. Difficile. [ Time Frame: 5 months ]

Secondary Outcome Measures :
  1. Determine the impact of IAD on therapeutic drug levels. Taper or change of immunosuppressive medications due to IAD. [ Time Frame: 5 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • all subjects aged >/= 18 years who qualify to receive a living (related or unrelated) or cadaveric kidney allograft using steroid free induction immunosuppression.
  • single organ recipient (kidney only)
  • subjects receiving first or second renal transplant
  • women of child-bearing potential should have a negative serum pregnancy test within 1 week prior to beginning study medications
  • subjects with no known contraindications to treatment with any of the study drugs
  • subjects providing written consent
  • subjects who are compliant and able to complete all the necessary assessment procedures

Exclusion Criteria:

  • Subjects < 18 years of age
  • Subjects who do not meet criteria for steroid free protocol
  • subjects with known intolerance to lactobacillus
  • subjects with history of chronic diarrhea
  • subjects with history of gastrointestinal disorder that may interfere with their ability to absorb oral medication: inflammatory bowel disease, irritable bowel syndrome, short gut syndrome, or ileo jejunal surgery
  • subjects with known laxative abuse
  • subjects with pancreatic insufficiency
  • subjects who are pregnant, lactating or nursing
  • subjects with active peptic ulcer disease
  • child bearing women not willing to use a reliable form of contraception
  • subjects with prior history of C. difficile
  • subjects receiving other medications considered to be experimental for control of diarrhea

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00364650

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United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Swedish Medical Center
Hoffmann-La Roche
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Principal Investigator: William H Marks, MD, PhD Swedish Medical Center

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Responsible Party: William H Marks MD PhD, Swedish Medical Center Identifier: NCT00364650    
Other Study ID Numbers: CEL346 (Main)
First Posted: August 15, 2006    Key Record Dates
Last Update Posted: July 26, 2011
Last Verified: July 2011
Keywords provided by Swedish Medical Center:
Renal transplantation
Additional relevant MeSH terms:
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Signs and Symptoms, Digestive
Signs and Symptoms
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs