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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2011 by University Hospital, Clermont-Ferrand.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier:
NCT00751452
First received: September 9, 2008
Last updated: January 18, 2011
Last verified: January 2011
History of Changes
  Purpose

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


Condition
Benign Disease

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Evaluation of Citrullinemia as a Marker of Bowel Damage After Allogeneic Bone Marrow Transplantation in Children

Resource links provided by NLM:

U.S. FDA Resources

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)

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

No publications provided

Responsible Party: Merlin Etienne, CHU Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT00751452     History of Changes
Other Study ID Numbers: CHU-0040
Study First Received: September 9, 2008
Last Updated: January 18, 2011
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

Additional relevant MeSH terms:
Citrullinemia
Urea Cycle Disorders, Inborn
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Amino Acid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on May 21, 2013