Short Bowel SyndromeNCT03773237
Intralipid Versus SMOFlipid in HPN Patients
A study testing SMOFLipid and Intralipid in people with Short Bowel Syndrome and Intestinal Fistula, run by Mayo Clinic at 1 site in United States.
Trial summary
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Short Bowel Syndrome, Intestinal Fistula, Crohn Disease
- What is being tested?
- SMOFLipid and Intralipid
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Dec 2018to 1 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Newly initiated Mayo Clinic HPN patient
- Able to provide informed consent
- Anticipated duration of HPN greater than 3 months,
- Infusion company is able to provide Smoflipid
Who cannot join
- Age less than 18 years
- Pregnant and lactating women
- Failure to provide consent
- Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
- Patients with active malignancy
- Patients who are deemed to be on HPN for less than three months
Show all 14Show fewer
- Patients who have previous proven addiction and dependence to alcohol/ heavy alcohol AND consumption/active use reported during last 12 months.
- Known hypersensitivity to fish, egg, soybean, or peanut protein, or to any of the active ingredients or excipients in Smoflipid
- Patients who will not be managed by the Mayo Clinic HPN team
- Patients who have active infection (as determined by the clinician) at the time of enrollment.
- Patients who have received Smoflipid greater than 4 weeks in the last 12 months prior to enrollment.
- Patients who have been on TPN greater than 4 weeks in the last 12 months prior to enrollment.
- Enrolled in another interventional study.
- Severe hyperlipidemia or severe disorders of lipid metabolism with serum triglycerides more than 1,000 mg/dL.
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
Read the detailed description
Primary aim is to assess the impact to direct/indirect bilirubin.
Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.
- Being tested
- SMOFLipid, Intralipid
- Keywords
- SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN
- Medical subject headings
- Short Bowel Syndrome, Intestinal Fistula, Crohn Disease, Intestinal Obstruction, Intestinal Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMOFLipidDietary supplement
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
IntralipidDietary supplement
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
| Study group | Role | What they receive |
|---|---|---|
| SMOFLipid | Active comparator | SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil. Receives: Dietary Supplement: SMOFLipid |
| IntraLipid | Active comparator | Intralipid is a lipid emulsion that contains soybean oil Receives: Dietary Supplement: Intralipid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Direct/Indirect Bilirubin Change is assessed
mg/dL
Measured: At 12 weeks weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2018
- Study start31 Dec 2018
- Primary completion1 Dec 2023
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Short Bowel SyndromeStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective Randomized Controlled
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manpreet S. Mundi, Mayo Clinic
- Investigators
- Manpreet S Mundi, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03773237
- Sponsor's protocol ID
- 17-001403
- Status last verified
- Oct 2024
- First submitted
- 12 Nov 2018
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Prospective Trial Comparing Intralipid Versus SMOFlipid in New HPN Patients.
- ClinicalTrials.gov ID
- NCT03773237
- Acronym / sponsor ID
- 17-001403
- Keywords
- SMOF, Intralipid, Mixed oil emulsion, Intestinal failure, HPN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 12 Dec 2018 (actual)
- 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.
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
Detailed description
Primary aim is to assess the impact to direct/indirect bilirubin.
Secondary aims will be to assess impact to other liver function studies, metabolic parameters, inflammatory marker, body weight, ability to meet caloric needs through TPN, and ability to obtain appropriate macronutrient composition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Prospective Randomized Controlled
| Arm | Type | Receives |
|---|---|---|
| SMOFLipid | Active comparator | Dietary Supplement: SMOFLipidSMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil. |
| IntraLipid | Active comparator | Dietary Supplement: IntralipidIntralipid is a lipid emulsion that contains soybean oil |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Newly initiated Mayo Clinic HPN patient
- Able to provide informed consent
- Anticipated duration of HPN greater than 3 months,
- Infusion company is able to provide Smoflipid
Key exclusion criteria (14 listed)
- Age less than 18 years
- Pregnant and lactating women
- Failure to provide consent
- Patients with underlying liver dysfunction (defined as liver function studies equal to or more than 2 times upper limit of normal) or pathology as determined by primary investigator
- Patients with active malignancy
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 |
|---|---|---|
| SMOFLipidSMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid. | Dietary supplement | SMOFLipid |
| IntralipidIntralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid | Dietary supplement | IntraLipid |
Primary outcome
Direct/Indirect Bilirubin Change is assessed
Time frame: At 12 weeks weeks
mg/dL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2025.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Manpreet S Mundi, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SMOFLipid and Intralipid in people with Short Bowel Syndrome and Intestinal Fistula, run by Mayo Clinic at 1 site in United States.
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 4 inclusion and 14 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: finished, as of the sponsor's last update on 16 May 2025. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Direct/Indirect Bilirubin Change is assessed (time frame: At 12 weeks weeks). 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 16 May 2025.