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Measuring omega-3 fatty acid levels in terminal ileal content following four weeks of omega-3 fatty acid supplementation in patients with a temporary ileostomy

A pilot study to measure omega-3 fatty acid levels in terminal ileal content following four weeks of omega-3 fatty acid supplementation in patients with a temporary ileostomy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14530452
Enrollment
8
Registered
2016-02-16
Start date
2016-02-10
Completion date
Unknown
Last updated
2022-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Participants with a loop ileostomy following anterior resection for colorectal cancer. Cancer

Interventions

All participants take two O3FA containing soft gel capsules twice daily with meals (total 1000 mg EPA and 1000 mg DHA daily) for 4 weeks. They are asked to provide a stoma fluid sample at 3 separate

Sponsors

University of Leeds (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Aged 50 years or over 2. Either gender 3. Temporary ileostomy fashioned at least 2 months prior to commencing study 4. Able to self medicate 5. A minimum period of 2 months availability for the study prior to planned ileostomy reversal

Exclusion criteria

Exclusion criteria: 1. Seafood allergy 2. Ongoing and/or previous use (within 4 weeks of commencing the study) of other O3FA or cod-liver oil supplements 3. Previous small bowel resection 4. Metastatic colorectal cancer 5. Less than 4 weeks since any chemotherapy or radiotherapy 6. Inflammatory bowel disease or other intestinal disease (e.g. coeliac disease)

Design outcomes

Primary

MeasureTime frame
Change in terminal ileal fluid EPA and DHA concentration at four weeks compared with baseline.

Secondary

MeasureTime frame
1. Change in percentage erythrocyte membrane content of EPA and DHA at four weeks compared with baseline. 2. Change in terminal ileal fluid EPA and DHA concentration within 24 hours of taking the first O3FA dose. 3. Tolerability and adverse events related to O3FA supplementation.

Countries

England, United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 21, 2026