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

University Health Network, Toronto

Status: Unknown

Conditions: Diarrhea; Immunosuppression

Treatments: Drug: Octreotide Acetate

Study type: Observational

Funder types: Other

Identifiers

NCT02977897

16-5998

Details and patient eligibility

About

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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

10 participants in 1 patient group

Diarrhea on MMF

Description:

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.

Treatment:

Drug: Octreotide Acetate