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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02977897
Enrollment
10
Registered
2016-11-30
Start date
2017-01-31
Completion date
Unknown
Last updated
2016-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diarrhea, Immunosuppression

Keywords

Diarrhea, Immunosuppression, Post-transplantation, Octreotide, Mycophenolate Mofetil, Fecal Calprotectin

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.

Interventions

DRUGOctreotide Acetate

Octreotide 100mcg SC q12h for 5 days

Sponsors

University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Measurement of Fecal Calprotectin levels patients with diarrhea on MMF3 months

Secondary

MeasureTime frame
Treatment of patients with MMF induced diarrhea with Octreotide5 days

Countries

Canada

Contacts

Primary ContactFlavio Habal, MD
dr.flavio.habal@uhn.ca4163405023

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026