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

This study has been completed.
Sponsor:
Collaborator:
Hoffmann-La Roche
Information provided by:
Swedish Medical Center
ClinicalTrials.gov Identifier:
NCT00364650
First received: August 11, 2006
Last updated: July 22, 2011
Last verified: July 2011

August 11, 2006
July 22, 2011
July 2006
December 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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.
Complete list of historical versions of study NCT00364650 on ClinicalTrials.gov Archive Site
Determine the impact of IAD on therapeutic drug levels. Taper or change of immunosuppressive medications due to IAD. [ Time Frame: 5 months ] [ Designated as safety issue: No ]
Determine the impact of IAD on therapeutic drug levels. Taper or change of immunosuppressive medications due to IAD.
Not Provided
Not Provided
 
Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation
Probiotic Prophylaxis for Immunosuppressant Associated Diarrhea (IAD) Following Kidney Transplantation: a Single Center Randomized Controlled Trial

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Immunosuppressant Associated Diarrhea
  • Drug: Probiotic Supplement
    2 capsules twice daily
    Other Name: Probiotic supplement
  • Other: Placebo
    placebo
    Other Name: placebo
  • Placebo Comparator: I
    Placebo
    Intervention: Other: Placebo
  • Experimental: II
    Probiotic supplement
    Intervention: Drug: Probiotic Supplement
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
December 2009
December 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00364650
CEL346 (Main)
Yes
William H Marks MD PhD, Swedish Medical Center
Swedish Medical Center
Hoffmann-La Roche
Principal Investigator: William H Marks, MD, PhD Swedish Medical Center
Swedish Medical Center
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP