title: Clinical trial: marine lipid suppositories as laxatives.
abstract: Cod-liver oil and other marine products containing polyunsaturated fatty acids have anti-inflammatory, anti-bacterial and anti-viral effects and may be useful in the treatment of various inflammatory and infectious diseases. We developed suppositories and ointment with 30% free fatty acid (FFA) extract from omega-3 fish oil. Our purpose was to evaluate the safety of marine lipid suppositories and ointment in healthy volunteers and to explore the laxative effect of the suppositories. Thirty healthy volunteers were randomized either to a study group administrating 30% FFA suppositories and applying 30% FFA ointment to the perianal region twice per day for two weeks, or to a control group using placebo suppositories and ointment in a double blinded manner.
  
  
  RESULTS
  No serious toxic effects or irritation were observed. In the study group 93% felt the urge to defecate after administration of the suppositories as compared to 37% in the control group (P = 0.001). Subsequently 90% in the study group defecated, compared to 33% in the control group (P = 0.001).
  
  
  CONCLUSIONS
  The marine lipid suppositories and ointment were well tolerated with no significant toxic side effects observed during the study period. The suppositories have a distinct laxative effect and we aim to explore this effect in further clinical trials.
authors.affiliation: Department of Pediatric Surgery, Children's Hospital, Landspitali-University Hospital, 101 Reykjavik, Iceland.|School of Health Science, University of Iceland, 101 Reykjavik, Iceland.
authors.forename: Orri Thor
authors.initials: OT
authors.lastname: Ormarsson
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.
authors.forename: Thormodur
authors.initials: T
authors.lastname: Geirsson
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.|Department of Internal Medicine, Landspitali-University Hospital, 101 Reykjavík, Iceland.
authors.forename: Einar Stefan
authors.initials: ES
authors.lastname: Bjornsson
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.|Department of Surgery, Landspitali-University Hospital, 101 Reykjavík, Iceland.
authors.forename: Tomas
authors.initials: T
authors.lastname: Jonsson
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.|Department of Surgery, Landspitali-University Hospital, 101 Reykjavík, Iceland.
authors.forename: Pall Hegli
authors.initials: PH
authors.lastname: Moller
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.
authors.forename: Thorsteinn
authors.identifier: 0000-0002-9439-1553
authors.initials: T
authors.lastname: Loftsson
authors.affiliation: School of Health Science, University of Iceland, 101 Reykjavik, Iceland.|Department of Surgery, Landspitali-University Hospital, 101 Reykjavík, Iceland.
authors.forename: Einar
authors.initials: E
authors.lastname: Stefansson
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D005260:Female; D005395:Fish Oils / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D006801:Humans; D054368:Laxatives / Q000008:administration & dosage* / Q000009:adverse effects / Q000737:chemistry; D008297:Male; D008875:Middle Aged; D009824:Ointments / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D013488:Suppositories / Q000008:administration & dosage / Q000009:adverse effects / Q000737:chemistry; D055815:Young Adult
chemical_list: D015525:Fatty Acids, Omega-3; D005395:Fish Oils; D054368:Laxatives; D009824:Ointments; D013488:Suppositories
keywords: clinical trial; laxative; ointment; omega-3 fatty acid; suppositories