DiarrheaNCT02977897
Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
An observational study of Diarrhea and Immunosuppression, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diarrhea, Immunosuppression
- What is being tested?
- Octreotide Acetate
- How many people
- 10 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Subjects with a known history of IBD or GVHD of the bowel.
- Any subject receiving Octreotide for another indication.
- Any patient unable to undergo endoscopy.
- Any patient with a contraindication to Octreotide therapy.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2N2
Flavio Habal, MD, PhD, 4163405023
About this study
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.
- Conditions
- Diarrhea, Immunosuppression
- Being tested
- Octreotide Acetate
- Keywords
- Diarrhea, Immunosuppression, Post-transplantation, Octreotide, Mycophenolate Mofetil, Fecal Calprotectin
- Medical subject headings
- Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octreotide AcetateDrug
Octreotide 100mcg SC q12h for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Diarrhea on MMF | 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. Receives: Drug: Octreotide Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of Fecal Calprotectin levels patients with diarrhea on MMF
Measured: 3 months
Secondary outcomes (1)
Treatment of patients with MMF induced diarrhea with Octreotide
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977897
- Sponsor's protocol ID
- 16-5998
- Status last verified
- Nov 2016
- First submitted
- 28 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Maes B, Hadaya K, de Moor B, Cambier P, Peeters P, de Meester J, Donck J, Sennesael J, Squifflet JP. Severe diarrhea in renal transplant patients: results of the DIDACT study. Am J Transplant. 2006 Jun;6(6):1466-72. doi: 10.1111/j.1600-6143.2006.01320.x.
PubMed 16686772Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0.
PubMed 10878285Knoll GA, MacDonald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol. 2003 Sep;14(9):2381-6. doi: 10.1097/01.asn.0000079616.71891.f5.
PubMed 12937317Arns W. Noninfectious gastrointestinal (GI) complications of mycophenolic acid therapy: a consequence of local GI toxicity? Transplant Proc. 2007 Jan-Feb;39(1):88-93. doi: 10.1016/j.transproceed.2006.10.189.
PubMed 17275481Feichtiger H, Wieland E, Armstrong VW, Shipkova M. The acyl glucuronide metabolite of mycophenolic acid induces tubulin polymerization in vitro. Clin Biochem. 2010 Jan;43(1-2):208-13. doi: 10.1016/j.clinbiochem.2009.08.023. Epub 2009 Sep 8.
PubMed 19744471Calmet FH, Yarur AJ, Pukazhendhi G, Ahmad J, Bhamidimarri KR. Endoscopic and histological features of mycophenolate mofetil colitis in patients after solid organ transplantation. Ann Gastroenterol. 2015 Jul-Sep;28(3):366-373.
PubMed 26126799Liapis G, Boletis J, Skalioti C, Bamias G, Tsimaratou K, Patsouris E, Delladetsima I. Histological spectrum of mycophenolate mofetil-related colitis: association with apoptosis. Histopathology. 2013 Nov;63(5):649-58. doi: 10.1111/his.12222. Epub 2013 Sep 11.
PubMed 24025088Sydora MJ, Sydora BC, Fedorak RN. Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome. J Crohns Colitis. 2012 Mar;6(2):207-14. doi: 10.1016/j.crohns.2011.08.008. Epub 2011 Sep 7.
PubMed 22325175Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Munoz JE. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab. Scand J Gastroenterol. 2016;51(4):442-7. doi: 10.3109/00365521.2015.1115546. Epub 2015 Nov 23.
PubMed 26595391Lorenz F, Marklund S, Werner M, Palmqvist R, Wahlin BE, Wahlin A. Fecal calprotectin as a biomarker of intestinal graft versus host disease after allogeneic hematopoietic stem cell transplantation. Sci Rep. 2015 Jan 21;5:7920. doi: 10.1038/srep07920.
PubMed 25605402Konikoff MR, Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Jun;12(6):524-34. doi: 10.1097/00054725-200606000-00013.
PubMed 16775498
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fecal Calprotectin Levels in Mycophenolate Mofetil Induced Diarrhea and Treatment With Octreotide
- ClinicalTrials.gov ID
- NCT02977897
- Acronym / sponsor ID
- 16-5998
- Conditions
- Diarrhea, Immunosuppression
- Keywords
- Diarrhea, Immunosuppression, Post-transplantation, Octreotide, Mycophenolate Mofetil, Fecal Calprotectin
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Nov 2017 (estimated)
- First posted
- 30 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diarrhea on MMF | – | Drug: Octreotide AcetateSolid 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- Subjects with a known history of IBD or GVHD of the bowel.
- Any subject receiving Octreotide for another indication.
- Any patient unable to undergo endoscopy.
- Any patient with a contraindication to Octreotide therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octreotide AcetateOctreotide 100mcg SC q12h for 5 days | Drug | Diarrhea on MMF |
Primary outcome
Measurement of Fecal Calprotectin levels patients with diarrhea on MMF
Time frame: 3 months
1 secondary outcome
Treatment of patients with MMF induced diarrhea with Octreotide
Time frame: 5 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2016.
- Background: PubMed 16686772Maes B, Hadaya K, de Moor B, Cambier P, Peeters P, de Meester J, Donck J, Sennesael J, Squifflet JP. Severe diarrhea in renal transplant patients: results of the DIDACT study. Am J Transplant. 2006 Jun;6(6):1466-72. doi: 10.1111/j.1600-6143.2006.01320.x.
- Background: PubMed 10878285Allison AC, Eugui EM. Mycophenolate mofetil and its mechanisms of action. Immunopharmacology. 2000 May;47(2-3):85-118. doi: 10.1016/s0162-3109(00)00188-0.
- Background: PubMed 12937317Knoll GA, MacDonald I, Khan A, Van Walraven C. Mycophenolate mofetil dose reduction and the risk of acute rejection after renal transplantation. J Am Soc Nephrol. 2003 Sep;14(9):2381-6. doi: 10.1097/01.asn.0000079616.71891.f5.
- Background: PubMed 17275481Arns W. Noninfectious gastrointestinal (GI) complications of mycophenolic acid therapy: a consequence of local GI toxicity? Transplant Proc. 2007 Jan-Feb;39(1):88-93. doi: 10.1016/j.transproceed.2006.10.189.
- Background: PubMed 19744471Feichtiger H, Wieland E, Armstrong VW, Shipkova M. The acyl glucuronide metabolite of mycophenolic acid induces tubulin polymerization in vitro. Clin Biochem. 2010 Jan;43(1-2):208-13. doi: 10.1016/j.clinbiochem.2009.08.023. Epub 2009 Sep 8.
- Background: PubMed 26126799Calmet FH, Yarur AJ, Pukazhendhi G, Ahmad J, Bhamidimarri KR. Endoscopic and histological features of mycophenolate mofetil colitis in patients after solid organ transplantation. Ann Gastroenterol. 2015 Jul-Sep;28(3):366-373.
- Background: PubMed 24025088Liapis G, Boletis J, Skalioti C, Bamias G, Tsimaratou K, Patsouris E, Delladetsima I. Histological spectrum of mycophenolate mofetil-related colitis: association with apoptosis. Histopathology. 2013 Nov;63(5):649-58. doi: 10.1111/his.12222. Epub 2013 Sep 11.
- Background: PubMed 22325175Sydora MJ, Sydora BC, Fedorak RN. Validation of a point-of-care desk top device to quantitate fecal calprotectin and distinguish inflammatory bowel disease from irritable bowel syndrome. J Crohns Colitis. 2012 Mar;6(2):207-14. doi: 10.1016/j.crohns.2011.08.008. Epub 2011 Sep 7.
- Background: PubMed 26595391Ferreiro-Iglesias R, Barreiro-de Acosta M, Lorenzo-Gonzalez A, Dominguez-Munoz JE. Usefulness of a rapid faecal calprotectin test to predict relapse in Crohn's disease patients on maintenance treatment with adalimumab. Scand J Gastroenterol. 2016;51(4):442-7. doi: 10.3109/00365521.2015.1115546. Epub 2015 Nov 23.
- Background: PubMed 25605402Lorenz F, Marklund S, Werner M, Palmqvist R, Wahlin BE, Wahlin A. Fecal calprotectin as a biomarker of intestinal graft versus host disease after allogeneic hematopoietic stem cell transplantation. Sci Rep. 2015 Jan 21;5:7920. doi: 10.1038/srep07920.
- Background: PubMed 16775498Konikoff MR, Denson LA. Role of fecal calprotectin as a biomarker of intestinal inflammation in inflammatory bowel disease. Inflamm Bowel Dis. 2006 Jun;12(6):524-34. doi: 10.1097/00054725-200606000-00013.
- Individual participant dataSharing planned: No
Related trials for Diarrhea
Not yet recruiting
Comparison of Two Probiotics for Reducing Diarrhea Frequency in Children Aged 6-24 Months
Acute Watery Diarrhea, Acute Watery Diarrhoea
RecruitingPhase 2
Long-Term Immunogenicity of the altSonflex1-2-3 Shigella Vaccine in African Children
Diarrhoea
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Diarrhea (IBS-D)
Irritable Bowel Syndrome, Diarrhea
Recruiting
Lactic Acid Bacteria in Functional Diarrheal Disorders
IBS-D (Diarrhea-predominant), IBS (Irritable Bowel Syndrome)
RecruitingPhase 2
Prophylactic Mesalamine to Prevent Colitis Following Treatment With Ipilimumab/Nivolumab (Ipi/Nivo)
Immune-related Adverse Event, Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Immunosuppression, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Flavio Habal, MD (4163405023, dr.flavio.habal@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of Fecal Calprotectin levels patients with diarrhea on MMF (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02977897, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Nov 2016.