Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

Study Overview
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Brief Summary
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Dehydration is a major problem of high output stoma with a 17% rate of readmission at 30 days. Dehydratations are resulting of significant electrolyte loss: sodium, potassium and renal failure. Nowadays, there are no recommendations nor national nor international for high output ileostomy treatment. Apart from the anti-diarrhea treatments used in current practice, somatostatin analogs have proven efficacy in the literature. Theses analogs permit to decrease significantly gastrointestinal secretions. Several teams use these analogs in order to decrease the flow of highly productive ileostomy. The aim of the study is to evaluate the efficacy first line treatment with lanreotide associated with current anti-diarrheal treatment for patients with high output ileostomy (or greater throughput 1.5l / 24h) with or without associated dehydration

Official Title
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Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study

Conditions
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High Output Stoma

Intervention / Treatment
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* Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)
* Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Legal at the time of signing the agreement Subject affiliated to the french social protection Ileostomy has achieved since 10 days minimum at day 0 (D0: start of study treatment) Ileostomy output > 1.5 liters / 24h for at least 24 hours at day 0 accept to use an effective method of contraception during the study: (during the 6 months following injection of lanreotide for the experimental group and for the control group: 4 days after the last dose of chlorhydrate of loperamide People able to understand the objectives, modalities and risks related to the study and give written informed consent Exclusion Criteria: people with guardianship or with judicial protection simultaneous participation in another biomedical research protocol involving a drug or topic exclusion period pregnancy or breastfeeding administration of lanreotide or related peptide between surgery and D0 hypersensitivities to lanreotide or related peptides and / or diosmectite and / or loperamide and / or one of their excipients acute hemorrhagic colitis bloody diarrhea and / or high fever Clostridium Difficile Infection at the inclusion uncontrolled diabetis defined by HbA1c> 7% at D0

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: lanreotide and anti-diarrheal treatments<br>Lanreotide: 1 single injection at day 0 (lanreotide 120 mg) Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) hydration | Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)<br> <br> |
| Active Comparator: Current anti-diarrheal treatments alone<br>Diosmectite (3 g) 6 / day for 72 hours (fromD0 to D3) Chlorhydrate of Loperamide (2 mg capsule or tablet) 6 / day for 72 hours (D0 to D3) Hydration | Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ileostomy bags used per day |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ileostomy bags used per day |  | from Day 0 to Day 6 | 
| Blood urea and creatinine rates |  | every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6) | 
| Length of stay |  | duration of hospital stay, an expected average of 6 days | 
| Serious adverse events |  | Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month |