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

NCT ID: NCT00364650

Last Updated: 2011-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-07-31
• Study Completion Date: 2009-12-31

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.

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.

Conditions

Immunosuppressant Associated Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

I

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

placebo

II

Probiotic supplement

Group Type: EXPERIMENTAL

Probiotic Supplement

Intervention Type: DRUG

2 capsules twice daily

Interventions

Probiotic Supplement

2 capsules twice daily

Intervention Type: DRUG

Placebo

placebo

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: collaborator

Swedish Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Swedish Medical Center

Principal Investigators

William H Marks, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Swedish Medical Center

Locations

Swedish Medical Center

Seattle, Washington, United States

Countries

United States

References

Cooper TE, Scholes-Robertson N, Craig JC, Hawley CM, Howell M, Johnson DW, Teixeira-Pinto A, Jaure A, Wong G. Synbiotics, prebiotics and probiotics for solid organ transplant recipients. Cochrane Database Syst Rev. 2022 Sep 20;9(9):CD014804. doi: 10.1002/14651858.CD014804.pub2.

Reference Type: DERIVED

PMID: 36126902 (View on PubMed)

Other Identifiers

CEL346 (Main)

Identifier Type: -

Identifier Source: org_study_id