Intestinal DiseasesPhase 3TewlipNCT02550860
Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
A Phase 3 study testing soybean oil (SO)-based IVFE (Medialipide) and fish oil (FO)-containing IVFE (Lipidem) in people with Intestinal Diseases, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Intestinal Diseases
- What is being tested?
- soybean oil (SO)-based IVFE (Medialipide) and fish oil (FO)-containing IVFE (Lipidem)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 2 sitesFrance
- Study dates
- Jan 2015to 8 Sep 2017
- 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
- Patient with sever chronic intestinal disease requiring long term parenteral nutrition
- Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
- With a stable dose of LCPN for at least 1 month at recruitment time
- Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
- Age >18
- Being available for 2 medical consultations in a 6 month period
- Who gave its written informed consent to participate to the study and without legal protection
- Social security coverage
Who cannot join
- Lesser expected parenteral nutrition length than duration for the entire trial
- Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
- Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance < 30 ml/min
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de Lyon
Lyon, 69002
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
About this study
The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance.
The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.
- Conditions
- Intestinal Diseases
- Being tested
- soybean oil (SO)-based IVFE (Medialipide), fish oil (FO)-containing IVFE (Lipidem)
- Keywords
- intravenous fat emulsions, parenteral nutrition, skin barrier function, essential fatty acids, transepidermal water loss
- Medical subject headings
- Intestinal Diseases, Hyperphagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
soybean oil (SO)-based IVFE (Medialipide)Drug
The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
fish oil (FO)-containing IVFE (Lipidem)Drug
The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal.
| Study group | Role | What they receive |
|---|---|---|
| soybean oil (SO)-based IVFE (Medialipide) | Active comparator | Not described Receives: Drug: soybean oil (SO)-based IVFE (Medialipide) |
| fish oil (FO)-containing IVFE (Lipidem) | Active comparator | fish oil (FO)-containing IVFE (Lipidem) Receives: Drug: fish oil (FO)-containing IVFE (Lipidem) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measured: at Day 0 (at recruitment time)
Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measured: at Day 90
Measurement of the transepidermal water loss (TEWL).
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measured: at Day 180
Secondary outcomes (12)
Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 0
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 0
Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 90
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 90
Determination of erythrocyte fatty acids ω-6
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 180
Determination of erythrocyte fatty acids ω-3
Essential fatty acid red blood cell monitoring more properly reflect the global membrane fatty acid composition of the body. Monitoring will be achieved at biochemistry laboratory of recruiting centers on a blood sample.
Measured: at Day 180
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 0
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 0
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 90
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 90
Determination of Stratum corneum (SC) ω-3
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 180
Determination of Stratum corneum (SC) ω-6
Stratum corneum lipids will be collected using the minimally invasive and painless "Tape Stripping" method, which consists of applying a scotch on the skin. Quantitative and qualitative composition of the SC lipid matrix will be determined using high-performance thin-layer chromatography.
Measured: at Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startJan 2015
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Why it stopped: problem of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intestinal DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Barnoud, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02550860
- Sponsor's protocol ID
- 2012-786
- Acronym
- Tewlip
- Status last verified
- Feb 2018
- First submitted
- 31 Aug 2015
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Fish Oil Based Intravenous Fat Emulsions on the Epidermal Barrier Function
- ClinicalTrials.gov ID
- NCT02550860
- Acronym / sponsor ID
- Tewlip / 2012-786
- Conditions
- Intestinal Diseases
- Keywords
- intravenous fat emulsions, parenteral nutrition, skin barrier function, essential fatty acids, transepidermal water loss
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: problem of enrollment
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 16 Sep 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.
The epidermal barrier efficacy is determined by the physicochemical properties of the epidermal lipid matrix, among which ω-6 essential fatty acids (EFAs) play a key role. Inversely, the ω-3 EFAs are not found in the epidermis. For patients receiving lipid-containing parenteral nutrition (LCPN), the improvement of the epidermal barrier through the infusion of most appropriate intravenous fat emulsions (IVFE) could have many applications in clinical nutrition, mainly limiting water loss in patients receiving long-term LCPN and help in electrolyte and water balance.
The objective of this interventional clinical trial is to evaluate the epidermal barrier function in patients receiving long-term LCPN comparing two compositions of IVFE: (i) soybean oil (SO)-based IVFE (Medialipide) or (ii) fish oil (FO)-containing IVFE (Lipidem). Epidermal barrier function will be assessed through the transepidermal water loss (TEWL) measurement on the skin surface, a validated marker of the epidermal barrier efficacy. The two IVFE (SO-based or FO-containing) will be compared using a randomized double blind crossover design, using patients as their own control. Each IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. Patient's epidermal and red blood cell EFA profile will be determinate in order to facilitate result interpretation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| soybean oil (SO)-based IVFE (Medialipide) | Active comparator | Drug: soybean oil (SO)-based IVFE (Medialipide) |
| fish oil (FO)-containing IVFE (Lipidem) | Active comparator | Drug: fish oil (FO)-containing IVFE (Lipidem)fish oil (FO)-containing IVFE (Lipidem) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patient with sever chronic intestinal disease requiring long term parenteral nutrition
- Receiving home lipid containing parenteral nutrition (LCPN), regardless of currently infused intravenous fat emulsion
- With a stable dose of LCPN for at least 1 month at recruitment time
- Administered at least 4 days a week through central venous access, with at least 150 mL of lipid per parenteral nutrition bag with lipid.
- Age >18
Key exclusion criteria (3 listed)
- Lesser expected parenteral nutrition length than duration for the entire trial
- Dermatological criteria : History of skin disease (atopic dermatitis, psoriasis) or evolving skin disease, broken or inflamed skin on the TEWL measurement site, Use of topical creams on the TEWL measurement site, Skin or systemic allergy (asthma)
- Contraindication to one of the selected intravenous fat emulsion: Severe dyslipidemia; Uncontrolled diabetes; Sepsis; Severe hepatic impairment; Major blood clotting disorders; Egg protein, soybean, peanut or fish hyper sensibility; Serum creatinine clearance < 30 ml/min
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 |
|---|---|---|
| soybean oil (SO)-based IVFE (Medialipide)The soybean oil (SO)-based IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. | Drug | soybean oil (SO)-based IVFE (Medialipide) |
| fish oil (FO)-containing IVFE (Lipidem)The fish oil (FO)-containing IVFE will be allocated for a 3-month period, allowing sufficient timeframe for epidermal complete renewal. | Drug | fish oil (FO)-containing IVFE (Lipidem) |
Primary outcome
Measurement of the transepidermal water loss (TEWL).
Time frame: at Day 0 (at recruitment time)
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measurement of the transepidermal water loss (TEWL).
Time frame: at Day 90
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
Measurement of the transepidermal water loss (TEWL).
Time frame: at Day 180
Measurement will be performed in a horizontal plane on the dominant volar forearm, which is the reference site for TEWL measurement because of its low content of sebaceous glands and pilosity. The TEWL will be measured using the latest generation of closed chamber system, combined to a vapor water condenser (Aquaflux 200®), which offers the advantage of a reduced TEWL value sensitivity to ambient humidity and temperature during measurement.
12 secondary outcomes
Determination of erythrocyte fatty acids ω-6
Time frame: at Day 0
Determination of erythrocyte fatty acids ω-3
Time frame: at Day 0
Determination of erythrocyte fatty acids ω-6
Time frame: at Day 90
Determination of erythrocyte fatty acids ω-3
Time frame: at Day 90
Determination of erythrocyte fatty acids ω-6
Time frame: at Day 180
Determination of erythrocyte fatty acids ω-3
Time frame: at Day 180
Determination of Stratum corneum (SC) ω-3
Time frame: at Day 0
Determination of Stratum corneum (SC) ω-6
Time frame: at Day 0
Determination of Stratum corneum (SC) ω-3
Time frame: at Day 90
Determination of Stratum corneum (SC) ω-6
Time frame: at Day 90
Determination of Stratum corneum (SC) ω-3
Time frame: at Day 180
Determination of Stratum corneum (SC) ω-6
Time frame: at Day 180
Results and safety
The study was stopped early (reason given: problem of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
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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.
Didier Barnoud, MD principal investigator
Hospices Civils de Lyon
2 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 soybean oil (SO)-based IVFE (Medialipide) and fish oil (FO)-containing IVFE (Lipidem) in people with Intestinal Diseases, run by Hospices Civils de Lyon at 2 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 8 inclusion and 3 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 28 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 (reason given: problem of enrollment). 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?
Measurement of the transepidermal water loss (TEWL). (time frame: at Day 0 (at recruitment time)). The study lists 3 primary outcomes in all. 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 28 Feb 2018.