Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide

• Conditions: Immunosuppression; Diarrhea
• Interventions: Drug: Octreotide Acetate

• Registration Number: NCT02977897
• Lead Sponsor: University Health Network, Toronto

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2016-11
• Study First Submitted: 2016-11-28
• Study First Submitted QC: 2016-11-28
• Last Update Submitted: 2016-11-28
• Study First Posted: 2016-11-30
• Last Update Posted: 2016-11-30
• Study Start: 2017-01
• Primary Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Read More

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.

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Diarrhea on MMF	Octreotide Acetate	Solid organ transplant recipients on MMF who develop diarrhea while taking the drug. Fecal calprotectin will be measured in their stool and Octreotide Acetate will be used to treat their diarrhea.

Primary Outcome Measures

Name	Time	Method
Measurement of Fecal Calprotectin levels patients with diarrhea on MMF	3 months

Secondary Outcome Measures

Name	Time	Method
Treatment of patients with MMF induced diarrhea with Octreotide	5 days

Trial Locations

Locations (1)

Toronto General Hospital, University Health Network; 🇨🇦 Toronto, Ontario, Canada