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. - taurine in HP

Phase 1

• Conditions: Complications of intravenous nutrition include cholestatic liver disease. This is one of the main causes of death during long-term home parenteral nutrition (HPN) and a study in 2000 found that 65% of patients on HPN developed chronic cholestasis after a median of 6 months and 41.5% developed HPN associated liver disease after a median of 17 months (Cavicchi 2000).

• Registration Number: EUCTR2005-000680-26-GB
• Lead Sponsor: orth west London Hospital Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-06-02
• Last Update Posted: 27 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

All patients over the age of 18 years on long term home parenteral nutrition under the care of the Nutrition and Intestinal Failure clinic at St Mark’s Hospital who have PNAC. Patients with intestinal failure on HPN rarely have liver biopsies as the results do not alter the patient’s management. A surrogate definition in the literature is based on persistently abnormal liver function tests (LFT’s). Chronic cholestasis has been defined as occurring when two of the three LFT’s are persistently elevated for over 6 months to a value of 1.5-fold the upper limit of normal (?- glutamyl-transferase, alkaline phosphatase, and serum conjugated bilirubin) (Nanji 1985). Patients would be expected to have a life expectancy of over 6 months and have been stable on HPN for 6 months before entry into the trial. HPN should provide >75-80% of their estimated nutritional requirements and patients should be on HPN for 5 days or more per week.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

No consent, pregnancy/lactation, planned surgery, renal failure, hepatic failure (prothrombin time twice the upper limit), ultrasound proven fibrosis or cirrhosis, poorly controlled diabetes, hepatitis B or C, autoimmune liver disease, receiving >40kcal/kg/day from HPN, current sepsis, co-existing surgical complications such as intestinal obstruction, hepatotoxic drugs, primary liver cancer or liver metastases or any other cause for pre and post hepatic jaundice, inability to adhere to the trial protocol or participation in another intervention trial.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine if the inclusion of 1g of intravenous taurine as part of the nitrogen source of parenteral nutrition reduces hepatobiliary complications. ;Secondary Objective: To determine if the inclusion of 1g of intravenous taurine alters plasma amino acid concentrations or urinary taurine excretion. Assessment of the effect of intravenous Taurine on dendritic cell function.;Primary end point(s): A reduction in bilirubin by 20% below the initial value. An increase in plasma taurine concentrations.<br> <br>