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A Trial of Taurine Supplementation in Parenteral Nutrition 1

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ClinicalTrials.gov Identifier: NCT00135044
Recruitment Status : Unknown
Verified September 2007 by London North West Healthcare NHS Trust.
Recruitment status was:  Recruiting
First Posted : August 25, 2005
Last Update Posted : September 24, 2007
Information provided by:

Study Description
Brief Summary:
The purpose of this study is to investigate whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease, a common side effect of parenteral nutrition.

Condition or disease Intervention/treatment
Cholestasis Procedure: intravenous taurine in nutritional supplement

Detailed Description:
Parenteral nutrition associated cholestasis (PNAC) is one of the main causes of death during long-term home parenteral nutrition (HPN). In one study 65% of patients on NPN developed PNAC after a median of 6 months and 41.5% developed HPN associated liver disease after a median of 17 months. It is thought that this condition develops due to changes in bile acid conjugation. Bile acids are conjugated with either taurine or glycine before their secretion in bile. Man obtains taurine mostly from the diet and hepatic taurine conjugation of bile acids accounts for 30-40% of the total bile acid pool. Taurine-conjugated bile acids are more water soluble and less toxic than glycine-conjugated bile acids. The ratio of glycine to taurine conjugated bile acids appears to be important and studies in rats have found that the bile acid sulfolithocholate, which is conjugated with glycine, was cholestatic while the taurine conjugated was not. Further studies in guinea pigs have shown that dietary taurine supplements prevent the cholestasis induced by sulfolithocholate by increasing the percentage of taurine conjugated bile acids. Patients on intravenous nutrition with intestinal failure may not re-absorb bile acids normally and may have increased losses of taurine conjugated of bile acids. They have also been found to have low levels of taurine. It is thought that chronic taurine deficiency, by altering the pattern of conjugation of bile acids, may predispose to cholestasis and ultimately severe hepatic dysfunction. In a study of hepatobiliary surgical patients given dietary taurine post operatively, there was enhanced conjugation and secretion of bile acids. Bilirubin levels fell during taurine supplementation compared to patients not receiving taurine although this was not significant. We are going to investigate if parenteral taurine supplementation is beneficial in our patients experiencing this condition.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: A Randomised Double Blind Controlled Crossover Trial of Intravenous Taurine Supplementation in Parenteral Nutrition as an Effective Treatment for Reducing Hepatobiliary Complications in Chronic Intestinal Failure
Study Start Date : June 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Taurine
U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :
  1. Whether the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces parenteral nutrition associated cholestatic liver disease

Secondary Outcome Measures :
  1. Can additional taurine affect septic complications occuring in patients receiving parenteral nutrition
  2. Can additional taurine improve dendritic cell function
  3. Do patients on home parenteral nutrition have low levels of taurine
  4. Does giving additional taurine cause an increase in levels of taurine
  5. Does giving additional taurine cause an increase in urinary taurine excretion

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Chronic intestinal failure (CIF) patients on long term home parenteral nutrition, under the care of the Nutrition and Intestinal Failure Clinic at St Mark's, who have PNAC.
  • Must be over 18
  • On HPN for 6 months and stable
  • Life expectancy of over 12 months
  • HPN should provide > 75-80% of estimated nutritional requirements
  • Should be on HPN for 5 or more days per week

Exclusion Criteria:

  • No consent.
  • Pregnancy/lactation.
  • Planned surgery.
  • Renal failure.
  • Hepatitic failure, ultrasound proven fibrosis or cirrhosis, poorly controlled diabetes, hepatitis B or C, autoimmune liver disease, receiving > 40 kcal/kg/day from HPN, current sepsis, co-existing surgical complications such as intestinal obstruction, hepatotoxic drugs, primary liver cancer or metastases or any other cause for pre and post hepatic jaundice.

Inability to adhere to the protocol.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00135044

Contact: Alison Culkin alison.culkin@nwlh.nhs.uk
Contact: Simon Gabe, MD simon.gabe@nwlh.nhs.uk

United Kingdom
North West London NHS Trust - St Mark's Hospital Recruiting
Harrow, London, Middlesex, United Kingdom, HA1 3Uj
Contact: Alan Warnes, PhD       alan.warnes@nwlh.nhs.uk   
Contact: Iva Hauptmannova       iva.hauptmannova@nwlh.nhs.uk   
Sponsors and Collaborators
London North West Healthcare NHS Trust
Fresenius AG
Principal Investigator: Simon Gabe, MD North West London NHS Trust - St Mark's Hospital
More Information

ClinicalTrials.gov Identifier: NCT00135044     History of Changes
Other Study ID Numbers: Taurine05
First Posted: August 25, 2005    Key Record Dates
Last Update Posted: September 24, 2007
Last Verified: September 2007

Keywords provided by London North West Healthcare NHS Trust:
intestinal failure
hepatobiliary complications
chronic intestinal failure (CIF)

Additional relevant MeSH terms:
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases