Intestinal FailureNCT03869957

Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure

A study testing Intervention group in people with Intestinal Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Randomized, double-blind, controlled clinical trial to evaluate the effect of parenteral nutrition (PN) supplemented with lipid emulsions containing 0.1-0.2 g omega 3 polyunsaturated fatty acids (n-3 PUFA)/kg body weight/day for 7 days on malondialdehyde (MDA) levels, a marker of lipoperoxidation of reactive species… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Intestinal Failure
What is being tested?: Intervention group
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteMexico
Study dates: 1 Dec 2019to 30 Jun 2022
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
Patients with recent diagnosis of IF type II (an evolution >28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).

Who cannot join

Patients with contraindications for PN
Patients with known allergies to the components of the PN formula
Severe liver or renal insufficiency
Uncontrolled diabetes mellitus
Certain acute and life-threatening conditions
Immunological diseases (such as autoimmune diseases, human immunodeficiency virus infection, cancer, etc.)

Show all 9Show fewer

Those that take immunosuppressant medications
Severe hemorrhagic disorders
Pregnant or lactating

Trial locations and contacts

1 site in 1 country.

Mexico1 site

Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
Mexico City, Tlalpan, 14080

Other trials in Mexico

About this study

Read the detailed description

IF is the loss of intestinal function that affects the decrease in the absorption of macronutrients, water, and electrolytes, so it requires intravenous supplementation such as PN and/or intravenous fluids to maintain health and/or growth. IF type II is associated with complex infectious and metabolic complications and patients require PN for weeks or months. Long-term PN use, however, includes the risk of complications, among which a serious one is the intestinal failure-associated liver disease (1). It has been proposed that metabolic endotoxemia (2-3), inflammation (4) and oxidative stress (5) are involved in the development of this intestinal failure-associated liver disease.

Although some studies have reported beneficial effects of n-3 PUFA to prevent and reverse the liver disease associated with IF (6-7), due to its antioxidant (8-10) and anti-inflammatory activity (11-12) and in the modulation of the intestinal microbiota (13), the literature on the use of n-3 PUFA in non-critical patients with IF and PN is limited and the results have not been conclusive.

Therefore, a randomized, double-blind, controlled clinical trial to evaluate the effect of PN supplemented with lipid emulsions containing n-3 PUFA/kg body weight/day for 7 days on oxidative stress (concentrations of MDA), compared with a control group (without n-3 PUFA) will be performed.

Conditions: Intestinal Failure
Being tested: Intervention group
Keywords: omega 3 polyunsaturated fatty acids, intestinal failure, oxidative stress
Medical subject headings: Intestinal Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Intervention groupDietary supplement
Also called n-3 PUFAs
0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days

Study groups in NCT03869957
Study group	Role	What they receive
Intervention group	Experimental	We will use ~0.8-0.9 g/kg/day of Clinoleic® (80% olive oil/20 soybean oil) + 0.2-0.1 g/kg/day [Omegaven® ](100% fish oil), to cover the proposed amount of n-3 PUFAs for 7 days. The infusion rate should not exceed 0.5 ml Omegaven® / kg body weight / hour = 0.05 g fish oil / kg body weight / hour. The intervention group will return to PN without n-3 PUFA after 7 days. Receives: Dietary Supplement: Intervention group
Control group	No intervention	Will be administering ~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.

What is being measured

The primary outcome is the main question the study is designed to answer.

Change of malondialdehyde (MDA) in serum from baseline to day 7
Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.
Measured: Change from baseline (day 0) at day 7

Secondary outcomes (36)

Change of glutathione (GSH) in plasma from baseline to day 7
Measurement of glutathione (GSH) that is a marker for oxidative stress, determined in plasma in micromol/l.
Measured: Change from baseline (day 0) at day 7
Change of oxidized glutathione (GSSG) in plasma from baseline to day 7
Measurement of oxidized glutathione (GSSG) that is a marker for oxidative stress, determined in plasma in micromol/l.
Measured: Change from baseline (day 0) at day 7
Change of GSH/GSSG ratio from baseline to day 7
GSH and GSSG will be combined to report GSH/GSSG ratio in micromol/l
Measured: Change from baseline (day 0) at day 7
Change of carbonylated protein in serum from baseline to day 7.
Measurement of carbonylated protein that is a marker for oxidative stress, determined in serum in nmol/mg
Measured: Change from day 0 at day 7.
Change of lipopolysaccharide (LPS) in serum from baseline to day 7.
Measurement of lipopolysaccharide (LPS) that is a marker for metabolic endotoxemia, determined in serum in ng/dl.
Measured: Change from baseline (day 0) at day 7
Change of C-reactive protein (CRP) in serum from baseline to day 7.
Measurement of C-reactive protein (CRP) that is a marker for inflammation, determined in serum in pg/ml.
Measured: Change from baseline (day 0) at day 7
Change of glucose in serum from baseline to day 7
Concentration of glucose in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of nitrogen ureic in serum from baseline to day 7
Concentration of nitrogen ureic in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of urea in serum from baseline to day 7
Concentration of urea in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of creatinin in serum from baseline to day 7
Concentration of creatinin in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of sodium in serum from baseline to day 7
Concentration of sodium in serum according medical records, in mmol/l
Measured: Change from baseline (day 0) at day 7
Change of potassium in serum from baseline to day 7
Concentration of potassium in serum according medical records, in mmol/l
Measured: Change from baseline (day 0) at day 7
Change of phosphorus in serum from baseline to day 7
Concentration of phosphorus in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of magnesium in serum from baseline to day 7
Concentration of magnesium in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of total bilirubin in serum from baseline to day 7
Concentration of total bilirubin in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of direct bilirubin in serum from baseline to day 7
Concentration of direct bilirubin in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of indirect bilirubin in serum from baseline to day 7
Concentration of indirect bilirubin in serum according medical records, in mg/dl
Measured: Change from baseline (day 0) at day 7
Change of alanine aminotransferase in serum from baseline to day 7
Concentration of alanine aminotransferase in serum according medical records, in U/l
Measured: Change from baseline (day 0) at day 7
Change of aspartate aminotransferase in serum from baseline to day 7
Concentration of aspartate aminotransferase in serum according medical records, in U/l
Measured: Change from baseline (day 0) at day 7
Change of alkaline phosphatase in serum from baseline to day 7
Concentration of alkaline phosphatase in serum according medical records, in U/l
Measured: Change from baseline (day 0) at day 7
Frequency of patients with nutritional risk at baseline
Determine the frequency of patients with nutritional risk according the Nutritional Risk Assesment-2002 (NRS-2002) tool, in percentage.
Measured: At baseline (day 0)
Determine the type of intestinal failure at baseline.
Identify the classification of patients with intestinal failure according the ESPEN guidelines on chronic intestinal failure in adults, in percentage.
Measured: At baseline (day 0)
Frequency of primary diagnosis at baseline.
Determine the frequency of primary diagnosis according medical records, in percentage.
Measured: At baseline (day 0)
Assessment of resting energy expenditure at baseline
Measurement of resting energy expenditure at baseline with a calorimeter, in kcal/day
Measured: Baseline (day 0)
Assessment of nutritional prescription at baseline and at day 7
Determine the nutritional prescription at baseline, in kcal/day
Measured: At baseline (day 0) and at day 7
Frequency of the type and characteristics of nutritional support administered
Determine type and characteristics of nutritional support administered, according medical records, in percentage
Measured: At baseline (day 0) and at day 7
Assessment of height at baseline
Measurement of weight in centimeters
Measured: Baseline (day 0)
Assessment of weight at baseline and at the end of the follow-up
Measurement of weight in kilograms
Measured: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of body mass index at baseline and at the end of the follow-up
Weight and height will be combined to report BMI in kg/m^2
Measured: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of lean mass at baseline and at the end of the follow-up
Measurement of percentage of lean mass at baseline with a electric bioimpedance (InBody S10 ®).
Measured: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of fat mass at baseline and at the end of the follow-up
Measurement of percentage of fat mass at baseline with a electric bioimpedance (InBody S10 ®).
Measured: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of muscle function at baseline and at the end of the follow-up
Measurement of muscle function with a handgrip at baseline, in kilograms
Measured: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Length of stay at hospitalization area
Determine the length of stay from the date of admission to the date of discharge from the hospitalization area, in days
Measured: From the date of admission to the date of discharge from the hospitalization area (~ at day 30)
Rate of mortality
Evaluation of frequency of mortality, in percentage
Measured: At the end of the follow-up (~ at day 30)
Frequency of intestinal failure-associated liver disease (IFALD)
Determined with the elevation in alkaline phosphatase concentrations within the first 7-14 days with parenteral nutrition, by elevation in transaminase concentrations more than 1.5 times above the upper limit of reference, or by elevation in the total bilirubin or direct bilirubin concentrations >3, 4, 6 and 12 mg / dl
Measured: From baseline (day 0) to the end of the follow-up (~ at day 30)
Change in lipidomics in serum from day 0 to day 7
Change in lipidomic profile of the diferent lipid species
Measured: Change from baseline (day 0) to day 7

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201930 Jun 2022

First posted11 Mar 2019
Study start1 Dec 2019
Primary completion1 May 2022
Study completion30 Jun 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (13)Papers the sponsor has linked to this study.
Other trials for Intestinal FailureStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, double-blind, controlled clinical trial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 20 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03869957
Sponsor's protocol ID: 2846
Status last verified: Sep 2025
First submitted: 25 Feb 2019
Last updated: 25 Sep 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Pironi L, Arends J, Baxter J, Bozzetti F, Pelaez RB, Cuerda C, Forbes A, Gabe S, Gillanders L, Holst M, Jeppesen PB, Joly F, Kelly D, Klek S, Irtun O, Olde Damink SW, Panisic M, Rasmussen HH, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM, Shaffer J; Home Artificial Nutrition & Chronic Intestinal Failure; Acute Intestinal Failure Special Interest Groups of ESPEN. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr. 2015 Apr;34(2):171-80. doi: 10.1016/j.clnu.2014.08.017. Epub 2014 Sep 21.
PubMed 25311444
Korpela K, Mutanen A, Salonen A, Savilahti E, de Vos WM, Pakarinen MP. Intestinal Microbiota Signatures Associated With Histological Liver Steatosis in Pediatric-Onset Intestinal Failure. JPEN J Parenter Enteral Nutr. 2017 Feb;41(2):238-248. doi: 10.1177/0148607115584388. Epub 2016 Sep 30.
PubMed 25934046
Omata J, Pierre JF, Heneghan AF, Tsao FH, Sano Y, Jonker MA, Kudsk KA. Parenteral nutrition suppresses the bactericidal response of the small intestine. Surgery. 2013 Jan;153(1):17-24. doi: 10.1016/j.surg.2012.04.001. Epub 2012 Jun 13.
PubMed 22698933
Cadenas S, Cadenas AM. Fighting the stranger-antioxidant protection against endotoxin toxicity. Toxicology. 2002 Oct 30;180(1):45-63. doi: 10.1016/s0300-483x(02)00381-5.
PubMed 12324199
Lacaille F, Gupte G, Colomb V, D'Antiga L, Hartman C, Hojsak I, Kolacek S, Puntis J, Shamir R; ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. Intestinal failure-associated liver disease: a position paper of the ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):272-83. doi: 10.1097/MPG.0000000000000586.
PubMed 25272324
Nandivada P, Fell GL, Gura KM, Puder M. Lipid emulsions in the treatment and prevention of parenteral nutrition-associated liver disease in infants and children. Am J Clin Nutr. 2016 Feb;103(2):629S-34S. doi: 10.3945/ajcn.114.103986. Epub 2016 Jan 20.
PubMed 26791189
Burns DL, Gill BM. Reversal of parenteral nutrition-associated liver disease with a fish oil-based lipid emulsion (Omegaven) in an adult dependent on home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):274-80. doi: 10.1177/0148607112450301. Epub 2012 Jun 8.
PubMed 22683685
Ventro G, Chen M, Yang Y, Harmon CM. Molecular impact of omega 3 fatty acids on lipopolysaccharide-mediated liver damage. J Pediatr Surg. 2016 Jun;51(6):1039-43. doi: 10.1016/j.jpedsurg.2016.02.078. Epub 2016 Mar 2.
PubMed 27072665
Wu G, Zhou W, Zhao J, Pan X, Sun Y, Xu H, Shi P, Geng C, Gao L, Tian X. Matrine alleviates lipopolysaccharide-induced intestinal inflammation and oxidative stress via CCR7 signal. Oncotarget. 2017 Feb 14;8(7):11621-11628. doi: 10.18632/oncotarget.14598.
PubMed 28086227
Giordano E, Visioli F. Long-chain omega 3 fatty acids: molecular bases of potential antioxidant actions. Prostaglandins Leukot Essent Fatty Acids. 2014 Jan;90(1):1-4. doi: 10.1016/j.plefa.2013.11.002. Epub 2013 Dec 3.
PubMed 24345866
Calder PC. Omega-3 fatty acids and inflammatory processes: from molecules to man. Biochem Soc Trans. 2017 Oct 15;45(5):1105-1115. doi: 10.1042/BST20160474. Epub 2017 Sep 12.
PubMed 28900017
Osowska S, Kunecki M, Sobocki J, Tokarczyk J, Majewska K, Omidi M, Radkowski M, Fisk HL, Calder PC. Effect of changing the lipid component of home parenteral nutrition in adults. Clin Nutr. 2019 Jun;38(3):1355-1361. doi: 10.1016/j.clnu.2018.05.028. Epub 2018 Jun 6.
PubMed 29907355
Laparra JM, Sanz Y. Interactions of gut microbiota with functional food components and nutraceuticals. Pharmacol Res. 2010 Mar;61(3):219-25. doi: 10.1016/j.phrs.2009.11.001. Epub 2009 Nov 13.
PubMed 19914380

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effect of Parenteral Nutrition With n-3 PUFAs on Patients With Intestinal Failure
ClinicalTrials.gov ID: NCT03869957
Acronym / sponsor ID: 2846
Conditions: Intestinal Failure
Keywords: omega 3 polyunsaturated fatty acids, intestinal failure, oxidative stress
Study type: Interventional
Recruitment status: Completed
Enrolment: 20 participants (actual)
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
Study start: 1 Dec 2019 (actual)
Primary completion: 1 May 2022 (actual)
Study completion: 30 Jun 2022 (actual)
First posted: 11 Mar 2019 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2
Model description: Randomized, double-blind, controlled clinical trial

Arm	Type	Receives
Intervention group	Experimental	Dietary Supplement: Intervention groupWe will use ~0.8-0.9 g/kg/day of Clinoleic® (80% olive oil/20 soybean oil) + 0.2-0.1 g/kg/day [Omegaven® ](100% fish oil), to cover the proposed amount of n-3 PUFAs for 7 days. The infusion rate should not exceed 0.5 ml Omegaven® / kg body weight / hour = 0.05 g fish oil / kg body weight / hour. The intervention group will return to PN without n-3 PUFA after 7 days.
Control group	No intervention	–Will be administering ~1.0 g/kg/d the lipid emulsion Clinoleic® (80% olive oil/20 soybean oil) without n-3 PUFAs.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Patients admitted in the non-critical areas of the Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán (INCMNSZ) with a nutritional risk between January 2019 and July 2020 will be considered eligible.
Patients with recent diagnosis of IF type II (an evolution >28 days) originate from various gastrointestinal or systemic diseases (short bowel, intestinal fistula, intestinal dysmotility, mechanical obstruction, and extensive small bowel mucosal disease).

Key exclusion criteria (9 listed)

Patients with contraindications for PN
Patients with known allergies to the components of the PN formula
Severe liver or renal insufficiency
Uncontrolled diabetes mellitus
Certain acute and life-threatening conditions

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
Intervention groupAlso: n-3 PUFAs0.1-0.2 g n-3 PUFA/kg body weight/day for 7 days	Dietary supplement	Intervention group

Primary outcome

Change of malondialdehyde (MDA) in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Measurement of malondialdehyde (MDA) that is a marker for oxidative stress, determined in serum in ng/dl.

36 secondary outcomes

Change of glutathione (GSH) in plasma from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of oxidized glutathione (GSSG) in plasma from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of GSH/GSSG ratio from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of carbonylated protein in serum from baseline to day 7.
Time frame: Change from day 0 at day 7.
Change of lipopolysaccharide (LPS) in serum from baseline to day 7.
Time frame: Change from baseline (day 0) at day 7
Change of C-reactive protein (CRP) in serum from baseline to day 7.
Time frame: Change from baseline (day 0) at day 7
Change of glucose in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of nitrogen ureic in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of urea in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of creatinin in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of sodium in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of potassium in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of phosphorus in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of magnesium in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of total bilirubin in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of direct bilirubin in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of indirect bilirubin in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of alanine aminotransferase in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of aspartate aminotransferase in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Change of alkaline phosphatase in serum from baseline to day 7
Time frame: Change from baseline (day 0) at day 7
Frequency of patients with nutritional risk at baseline
Time frame: At baseline (day 0)
Determine the type of intestinal failure at baseline.
Time frame: At baseline (day 0)
Frequency of primary diagnosis at baseline.
Time frame: At baseline (day 0)
Assessment of resting energy expenditure at baseline
Time frame: Baseline (day 0)
Assessment of nutritional prescription at baseline and at day 7
Time frame: At baseline (day 0) and at day 7
Frequency of the type and characteristics of nutritional support administered
Time frame: At baseline (day 0) and at day 7
Assessment of height at baseline
Time frame: Baseline (day 0)
Assessment of weight at baseline and at the end of the follow-up
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of body mass index at baseline and at the end of the follow-up
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of lean mass at baseline and at the end of the follow-up
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of percentage of fat mass at baseline and at the end of the follow-up
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Assessment of muscle function at baseline and at the end of the follow-up
Time frame: At baseline (day 0) and at the end of the follow-up (~ at day 30)
Length of stay at hospitalization area
Time frame: From the date of admission to the date of discharge from the hospitalization area (~ at day 30)
Rate of mortality
Time frame: At the end of the follow-up (~ at day 30)
Frequency of intestinal failure-associated liver disease (IFALD)
Time frame: From baseline (day 0) to the end of the follow-up (~ at day 30)
Change in lipidomics in serum from day 0 to day 7
Time frame: Change from baseline (day 0) to day 7

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 25 Sep 2025.
Results publication: PubMed 25311444Pironi L, Arends J, Baxter J, Bozzetti F, Pelaez RB, Cuerda C, Forbes A, Gabe S, Gillanders L, Holst M, Jeppesen PB, Joly F, Kelly D, Klek S, Irtun O, Olde Damink SW, Panisic M, Rasmussen HH, Staun M, Szczepanek K, Van Gossum A, Wanten G, Schneider SM, Shaffer J; Home Artificial Nutrition & Chronic Intestinal Failure; Acute Intestinal Failure Special Interest Groups of ESPEN. ESPEN endorsed recommendations. Definition and classification of intestinal failure in adults. Clin Nutr. 2015 Apr;34(2):171-80. doi: 10.1016/j.clnu.2014.08.017. Epub 2014 Sep 21.
Results publication: PubMed 25934046Korpela K, Mutanen A, Salonen A, Savilahti E, de Vos WM, Pakarinen MP. Intestinal Microbiota Signatures Associated With Histological Liver Steatosis in Pediatric-Onset Intestinal Failure. JPEN J Parenter Enteral Nutr. 2017 Feb;41(2):238-248. doi: 10.1177/0148607115584388. Epub 2016 Sep 30.
Results publication: PubMed 22698933Omata J, Pierre JF, Heneghan AF, Tsao FH, Sano Y, Jonker MA, Kudsk KA. Parenteral nutrition suppresses the bactericidal response of the small intestine. Surgery. 2013 Jan;153(1):17-24. doi: 10.1016/j.surg.2012.04.001. Epub 2012 Jun 13.
Results publication: PubMed 12324199Cadenas S, Cadenas AM. Fighting the stranger-antioxidant protection against endotoxin toxicity. Toxicology. 2002 Oct 30;180(1):45-63. doi: 10.1016/s0300-483x(02)00381-5.
Results publication: PubMed 25272324Lacaille F, Gupte G, Colomb V, D'Antiga L, Hartman C, Hojsak I, Kolacek S, Puntis J, Shamir R; ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. Intestinal failure-associated liver disease: a position paper of the ESPGHAN Working Group of Intestinal Failure and Intestinal Transplantation. J Pediatr Gastroenterol Nutr. 2015 Feb;60(2):272-83. doi: 10.1097/MPG.0000000000000586.
Results publication: PubMed 26791189Nandivada P, Fell GL, Gura KM, Puder M. Lipid emulsions in the treatment and prevention of parenteral nutrition-associated liver disease in infants and children. Am J Clin Nutr. 2016 Feb;103(2):629S-34S. doi: 10.3945/ajcn.114.103986. Epub 2016 Jan 20.
Results publication: PubMed 22683685Burns DL, Gill BM. Reversal of parenteral nutrition-associated liver disease with a fish oil-based lipid emulsion (Omegaven) in an adult dependent on home parenteral nutrition. JPEN J Parenter Enteral Nutr. 2013 Mar;37(2):274-80. doi: 10.1177/0148607112450301. Epub 2012 Jun 8.
Results publication: PubMed 27072665Ventro G, Chen M, Yang Y, Harmon CM. Molecular impact of omega 3 fatty acids on lipopolysaccharide-mediated liver damage. J Pediatr Surg. 2016 Jun;51(6):1039-43. doi: 10.1016/j.jpedsurg.2016.02.078. Epub 2016 Mar 2.
Results publication: PubMed 28086227Wu G, Zhou W, Zhao J, Pan X, Sun Y, Xu H, Shi P, Geng C, Gao L, Tian X. Matrine alleviates lipopolysaccharide-induced intestinal inflammation and oxidative stress via CCR7 signal. Oncotarget. 2017 Feb 14;8(7):11621-11628. doi: 10.18632/oncotarget.14598.
Results publication: PubMed 24345866Giordano E, Visioli F. Long-chain omega 3 fatty acids: molecular bases of potential antioxidant actions. Prostaglandins Leukot Essent Fatty Acids. 2014 Jan;90(1):1-4. doi: 10.1016/j.plefa.2013.11.002. Epub 2013 Dec 3.
Results publication: PubMed 28900017Calder PC. Omega-3 fatty acids and inflammatory processes: from molecules to man. Biochem Soc Trans. 2017 Oct 15;45(5):1105-1115. doi: 10.1042/BST20160474. Epub 2017 Sep 12.
Results publication: PubMed 29907355Osowska S, Kunecki M, Sobocki J, Tokarczyk J, Majewska K, Omidi M, Radkowski M, Fisk HL, Calder PC. Effect of changing the lipid component of home parenteral nutrition in adults. Clin Nutr. 2019 Jun;38(3):1355-1361. doi: 10.1016/j.clnu.2018.05.028. Epub 2018 Jun 6.

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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.

Aurora E Serralde-Zúñiga, MD, PhD principal investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Intervention group in people with Intestinal Failure, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.

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 2 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: finished, as of the sponsor's last update on 25 Sep 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 Mexico. 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?

Change of malondialdehyde (MDA) in serum from baseline to day 7 (time frame: Change from baseline (day 0) at day 7). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03869957, which also lists 13 linked publications.

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 25 Sep 2025.