This is a randomized controlled, parallel group, open label versus "no treatment" trial which evaluate the efficacy of rhGH on weaning off parenteral nutrition in children with short bowel syndrome.The total follow-up is 14 months; 4 months for each group after randomization; At the end of the first four months: the treated group will be followed within 6 months, the untreated group will receive compassionately rhGH for 4 months and followed-up for 6 months after the end of the treatment period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Alain LACHAUX
Lyon, France
Evaluate the efficacy of rhGH compared to "no treatment" on partial or total weaning off of parenteral nutrition in children with short bowel syndrome after 4 months
Time frame: 4 months
Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.
Time frame: 6 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)
Time frame: 4 months
To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)
Time frame: 14 months
To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)
Time frame: 4 months
To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)
Time frame: 4 months
To quantify the variation in body composition (auxology) at the end of study (month 14)
Time frame: 14 months
To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14)
Time frame: 14 months
number of adverse events
Time frame: 4 months
number of adverse events glucose intolerance
Time frame: 4 months
number of adverse event
To evaluate the tolerance of rhGH at the end of study (month 14).
Time frame: 14 months
number of adverse events glucose intolerance
Time frame: 14 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.