A Trial of Taurine Supplementation in Parenteral Nutrition 1

• ClinicalTrials.gov Identifier: NCT00135044
• Recruitment Status: Unknown
• First Posted: August 25, 2005
• Last Update Posted: September 24, 2007
• Sponsor: London North West Healthcare NHS Trust
• Collaborator: Fresenius AG
• Information provided by: London North West Healthcare NHS Trust

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	Phase
Cholestasis	Procedure: intravenous taurine in nutritional supplement	Not Applicable

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

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

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

Criteria

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

Contacts

Contact: Alison Culkin; alison.culkin@nwlh.nhs.uk

Contact: Simon Gabe, MD; simon.gabe@nwlh.nhs.uk

Locations

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

Investigators

• Principal Investigator: Simon Gabe, MD; North West London NHS Trust - St Mark's Hospital

More Information

• ClinicalTrials.gov Identifier: NCT00135044
• Other Study ID Numbers: Taurine05
• First Posted: August 25, 2005
• Last Update Posted: September 24, 2007
• Last Verified: September 2007

Keywords provided by London North West Healthcare NHS Trust:

taurine; intestinal failure; HPN; hepatobiliary complications; chronic intestinal failure (CIF)

Additional relevant MeSH terms:

Cholestasis; Bile Duct Diseases; Biliary Tract Diseases; Digestive System Diseases