High Output StomaPhase 3ILEHOSNCT02354768
Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
A Phase 3 study testing Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) and Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone in people with High Output Stoma, run by University Hospital, Strasbourg, France at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High Output Stoma
- What is being tested?
- Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) and Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 6 sitesFrance
- Study dates
- 22 Oct 2015to 26 Jan 2018
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- bloody diarrhea and / or high fever
- Clostridium Difficile Infection at the inclusion
- uncontrolled diabetis defined by HbA1c> 7% at D0
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Hôpital Jean Minjoz - Service de Chirurgie Digestive
Besançon, 25030
Hôpitaux Civils de Colmar - Service de Chirurgie Digestive
Colmar, 68024
Hopital du Bocage - CHU Dijon- Service de Chirurgie Digestive
Dijon
Hôpital Emile MULLER - Service de Chirurgie Digestive
Mulhouse, 68070
CHU Robert Debré Service de chirurgie générale, digestive et endocrinienne
Reims, 51100
Hôpital de Hautepierre-Service de Chirurgie Digestive
Strasbourg, 67098
About this study
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
- Conditions
- High Output Stoma
- Being tested
- Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide), Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)Drug
Effects of current anti-diarrheal treatments (diosmectite and loperamide) aloneDrug
| Study group | Role | What they receive |
|---|---|---|
| lanreotide and anti-diarrheal treatments | Experimental | * 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 Receives: Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) |
| Current anti-diarrheal treatments alone | Active comparator | * 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 Receives: Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of ileostomy bags used per day
Measured: 72 hours
Secondary outcomes (4)
Number of ileostomy bags used per day
Measured: from Day 0 to Day 6
Blood urea and creatinine rates
Measured: every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6)
Length of stay
Measured: duration of hospital stay, an expected average of 6 days
Serious adverse events
Measured: Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study start22 Oct 2015
- Primary completion31 Dec 2017
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Output StomaStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Benoit ROMAIN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354768
- Sponsor's protocol ID
- 5971
- Acronym
- ILEHOS
- Status last verified
- Mar 2018
- First submitted
- 26 Jan 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
- ClinicalTrials.gov ID
- NCT02354768
- Acronym / sponsor ID
- ILEHOS / 5971
- Conditions
- High Output Stoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 3 Feb 2015 (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.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| lanreotide and anti-diarrheal treatments | Experimental | Drug: Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide)* 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 |
| Current anti-diarrheal treatments alone | Active comparator | Drug: Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone* 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) | Drug | lanreotide and anti-diarrheal treatments |
| Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone | Drug | Current anti-diarrheal treatments alone |
Primary outcome
Number of ileostomy bags used per day
Time frame: 72 hours
4 secondary outcomes
Number of ileostomy bags used per day
Time frame: from Day 0 to Day 6
Blood urea and creatinine rates
Time frame: every 2 days until Day6 (Day 0, Day 2, Day 4, Day 6)
Length of stay
Time frame: duration of hospital stay, an expected average of 6 days
Serious adverse events
Time frame: Day 0, Day 1 Day 2, Day3, Day 4, Day 5, Day 6, 1 month
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
- Individual participant dataSharing planned: No
Related trials for High Output Stoma
Recruiting
Study of Treatment With Intensified Omeprazole Treatment to Prevent High Output Stoma 1
Stoma - Ileostomy, High Output Stoma
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.
Benoit ROMAIN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Effects of lanreotide with current anti-diarrheal treatments (diosmectite and loperamide) and Effects of current anti-diarrheal treatments (diosmectite and loperamide) alone in people with High Output Stoma, run by University Hospital, Strasbourg, France at 6 sites in France.
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 6 inclusion and 9 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: stopped early, as of the sponsor's last update on 7 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of ileostomy bags used per day (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2018.