The Effects of Parenteral ω-3 Polyunsaturated Fatty Acid on Postoperative Complications of Patients With Crohn's Disease

Study Purpose

This study is intended to investigate the safety and efficacy of ω-3 polyunsaturated fatty acid-based parenteral nutrition (PN) for patients with Crohn's disease.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Diagnosis as Crohn's disease according to definition; 2. Bowel resection; 3. With parenteral nutrition at least 5 days 4. 18 years oldExclusion Criteria: 1. Emergency surgery; 2. With severe comorbidity and/or organ (kidney,liver,or heart) dysfunction; 3. Incomplete laboratory data; 4. With parenteral nutrition before surgery; 5. Pregnant; 6. Allergy of ω-3 polyunsaturated fatty acid.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03901937
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Sir Run Run Shaw Hospital
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Xiujun Cai
Principal Investigator Affiliation Sir Run Run Shaw Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Arms & Interventions

Arms

Placebo Comparator: Placebo

parenteral nutrition without ω-3 polyunsaturated fatty acid

Experimental: ω-3 fatty acid

parenteral nutrition with ω-3 polyunsaturated fatty acid

Interventions

Drug: - ω-3 polyunsaturated fatty acid

CD patients are divided into two groups, which include with and without ω-3 polyunsaturated fatty acid-based PN (0.1-0.2g/kg/d).

Procedure: - Intestinal surgery for Crohn's Disease

Patients receive bowel resection due to complications of Crohn's Disease

Contact a Trial Team

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International Sites

Sir Run Run Shaw hospital, Hangzhou, Zhejiang, China

Status

Recruiting

Address

Sir Run Run Shaw hospital

Hangzhou, Zhejiang, 310016

Site Contact

Xiaolong Ge, PhD

gxlnjumed09@126.com

13867106984

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