- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00135044
A Trial of Taurine Supplementation in Parenteral Nutrition 1
September 21, 2007 updated by: London North West Healthcare NHS Trust
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
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Anticipated)
24
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Simon Gabe, MD
- Email: simon.gabe@nwlh.nhs.uk
Study Contact Backup
- Name: Alison Culkin
- Email: alison.culkin@nwlh.nhs.uk
Study Locations
-
-
Middlesex
-
Harrow, London, Middlesex, United Kingdom, HA1 3Uj
- Recruiting
- North West London NHS Trust - St Mark's Hospital
-
Contact:
- Alan Warnes, PhD
- Email: alan.warnes@nwlh.nhs.uk
-
Contact:
- Iva Hauptmannova
- Email: iva.hauptmannova@nwlh.nhs.uk
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 63 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
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
Outcome Measure |
---|
Can additional taurine affect septic complications occuring in patients receiving parenteral nutrition
|
Can additional taurine improve dendritic cell function
|
Do patients on home parenteral nutrition have low levels of taurine
|
Does giving additional taurine cause an increase in levels of taurine
|
Does giving additional taurine cause an increase in urinary taurine excretion
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Simon Gabe, MD, North West London NHS Trust - St Mark's Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2005
Study Registration Dates
First Submitted
August 24, 2005
First Submitted That Met QC Criteria
August 24, 2005
First Posted (Estimate)
August 25, 2005
Study Record Updates
Last Update Posted (Estimate)
September 24, 2007
Last Update Submitted That Met QC Criteria
September 21, 2007
Last Verified
September 1, 2007
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Taurine05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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