Clinical trial NCT02977897: Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
Official title: Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Diarrhea
Immunosuppression
Keywords: Diarrhea
Immunosuppression
Post-transplantation
Octreotide
Mycophenolate Mofetil
Fecal Calprotectin
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2016-11-30
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Males and females between the ages of 18 and 75 years who are solid organ transplant recipients on mycophenolate mofetil (MMF) referred to gastroenterology at Toronto General Hospital for diarrhea.

Brief summary: Prospective, observational pilot study of ten post-transplant patients presenting with diarrhea while taking Mycophenolate Mofetil (MMF). These patients will undergo a standard workup to confirm MMF induced diarrhea. A stool fecal calprotectin will be measured to determine if it may be helpful in confirming the diagnosis of MMF associated diarrhea. Once the diagnosis is confirmed, the patients will then be treated with a short course of subcutaneous Octreotide which has been shown to cure this type of diarrhea.


Eligibility criteria: Inclusion Criteria:

* Male and female patients between the ages of 18 and 75 years old who are solid organ transplant recipients followed at Toronto General Hospital on MMF referred to gastroenterology for diarrhea.

Exclusion Criteria:

1. Subjects with a known history of IBD or GVHD of the bowel.
2. Any subject receiving Octreotide for another indication.
3. Any patient unable to undergo endoscopy.
4. Any patient with a contraindication to Octreotide therapy.

Primary outcomes:
measure: Measurement of Fecal Calprotectin levels patients with diarrhea on MMF
timeFrame: 3 months
Secondary outcomes:
measure: Treatment of patients with MMF induced diarrhea with Octreotide
timeFrame: 5 days
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, University Health Network
state: Ontario
Study officials:
References:
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