Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children - Full Text View

Citrulline Allo. Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

This study is currently recruiting participants.
Verified by University Hospital, Clermont-Ferrand, September 2008

Sponsored by:	University Hospital, Clermont-Ferrand
Information provided by:	University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:	NCT00751452

Purpose

determine the interest of the dosage of citrullinemia to monitor the bowel damage after allogeneic bone marrow transplantation in children.

Condition

Benign Disease

Genetics Home Reference related topics:

3-hydroxy-3-methylglutaryl-coenzyme A lyase deficiency argininosuccinic aciduria citrullinemia N-acetylglutamate synthase deficiency ornithine translocase deficiency

MedlinePlus related topics:

Bone Marrow Transplantation

ChemIDplus related topics:

Citrulline

U.S. FDA Resources

Study Type:	Observational
Study Design:	Other, Prospective

Official Title:	Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

Further study details as provided by University Hospital, Clermont-Ferrand:

Primary Outcome Measures:

Citrullinemia (weekly) [ Time Frame: weekly ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Gastro-intestinal complications in children following allogeneic bone marrow transplantation [ Time Frame: following allogenic bone marrow transplantation ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	30
Study Start Date:	April 2008
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts

Detailed Description:

30 children included. Dosage of citrullinemia on day -7, day 0 and every week up to 100 days after BMT. Histological examination and extensive infectious screening in case of persistent digestive symptoms (more than 3 days).

Two groups of patients regarding on digestive involvement. Comparison of the values of citrullinemia between these two groups.

Eligibility

Ages Eligible for Study:	up to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

screening

Criteria

Inclusion Criteria:

0 to 18 years
allogeneic bone marrow transplantation for malignant or benign disease
affiliation to French sécurité sociale
parent's consent

Exclusion Criteria:

severe gastro-intestinal involvement before transplant
previous digestive surgery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00751452

Contacts


Contact: Lacarin Patrick		placarin@chu-clermontferrand.fr

Locations


France
	Etienne MERLIN	Recruiting
	Clermont-Ferrand, France, 63003

Sponsors and Collaborators

University Hospital, Clermont-Ferrand

Investigators


Principal Investigator:	Merlin Etienne, Dr	University Hospital, Clermont-Ferrand

More Information

Responsible Party:	CHU Clermont-Ferrand ( Merlin Etienne )
Study ID Numbers:	CHU-0040
First Received:	September 9, 2008
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00751452
Health Authority:	France: Ministry of Health

Keywords provided by University Hospital, Clermont-Ferrand:

Children

Allogeneic bone marrow transplantation

Intestinal damage

Citrulline

Graft versus Host Disease

0 to 18 years old

Study placed in the following topic categories:

Metabolic Diseases

Amino Acid Metabolism, Inborn Errors

Graft versus host disease

Central Nervous System Diseases

Brain Diseases

Homologous wasting disease

Metabolism, Inborn Errors

Inborn amino acid metabolism disorder

Genetic Diseases, Inborn

Graft vs Host Disease

Brain Diseases, Metabolic, Inborn

Metabolic disorder

Citrullinemia

Brain Diseases, Metabolic

Argininosuccinate synthetase deficiency

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 06, 2008