NCT00364650

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 11, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 15, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 26, 2011

Status Verified

July 1, 2011

Enrollment Period

3.4 years

First QC Date

August 11, 2006

Last Update Submit

July 22, 2011

Conditions

Immunosuppressant Associated Diarrhea

Keywords

Renal transplantationDiarrheaImmunosuppressionProbiotics

Outcome Measures

Primary Outcomes (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.

    5 months

Secondary Outcomes (1)

  • Determine the impact of IAD on therapeutic drug levels. Taper or change of immunosuppressive medications due to IAD.

    5 months

Study Arms (2)

I

PLACEBO COMPARATOR

Placebo

Other: Placebo

II

EXPERIMENTAL

Probiotic supplement

Drug: Probiotic Supplement

Interventions

Probiotic SupplementDRUG

2 capsules twice daily

II
PlaceboOTHER

placebo

I

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Swedish Medical Center

Seattle, Washington, 98122, United States

Location

Related Publications (1)

  • 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.

    PMID: 36126902DERIVED

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • William H Marks, MD, PhD

    Swedish Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 11, 2006

First Posted

August 15, 2006

Study Start

July 1, 2006

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 26, 2011

Record last verified: 2011-07

Locations

US(1)