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

Benign Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00751452
• Other study ID #: CHU-0040
• Status: Recruiting
• Phase: N/A
• First received: September 9, 2008
• Last updated: January 18, 2011
• Start date: April 2008
• Est. completion date: September 2009

Study information

• Verified date: January 2011
• Source: University Hospital, Clermont-Ferrand
• Contact: Lacarin Patrick
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Benign Disease
• Citrullinemia

Locations

Country	Name	City	State
France	Etienne MERLIN	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Citrullinemia (weekly)		weekly	Yes
Secondary	Gastro-intestinal complications in children following allogeneic bone marrow transplantation		following allogenic bone marrow transplantation	Yes