An interventional study of SMOFLipid and Intralipid in Short Bowel Syndrome, Intestinal Fistula and Crohn Disease, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-16.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Supportive care
This study will randomize all patients who are new to the Mayo Clinic HPN team to either standard lipid emulsion (Intralipid) or SMOFLipid.
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.
159 studies on the registry are indexed under Short Bowel Syndrome; 24 are open to participants now.
This study's enrollment of 22 is close to the median of 21 across 108 interventional studies indexed under Short Bowel Syndrome.
Browse Short Bowel Syndrome studies →Mayo Clinic is the lead sponsor of 3,269 studies on the registry; 672 are open to participants now.
Of its 452 completed or terminated interventional studies of FDA-regulated products, 321 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
SMOFlipid is a lipid emulsion that contains a combination of soybean oil, medium chain triglycerides, olive oil, and fish oil.
Dietary Supplement: SMOFLipid
Intralipid is a lipid emulsion that contains soybean oil
Dietary Supplement: Intralipid
SMOFLipid will be given to HPN patients to assess the benefits or adverse effects compared to Intralipid.
Intralipid will be given to HPN patients to assess the benefits or adverse effects compared to SMOFlipid
Direct/Indirect Bilirubin Change is assessed
mg/dL
Time frame: At 12 weeks weeks
Plan to share: No
Ran from Dec 2018 to primary completion in Dec 2023, 59 months.
Of 24 interventional studies with no phase under Short Bowel Syndrome, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 59. This study's 59 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: SMOFlipid · Soybean oil, phospholipid emulsion