Evaluation of the Efficacy and Safety of Recombinant Human Growth Hormone (rhGH) in the Treatment of Children With Short Bowel Syndrome

Civil Hospices of Lyon

Status and phase

Completed

Phase 3

Conditions

Short Bowel Syndrome

Treatments

Drug: rhGH

Study type

Interventional

Funder types

Other

Identifiers

NCT00169637

2002.301

Details and patient eligibility

About

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.

Enrollment

14 patients

Sex

All

Ages

3 to 18 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Age 3-18 year with a bone age test under 18-year Children with short bowel syndrome and intestinal insufficiency, the remaining bowel length should be under 80 cm after the first post-surgical period.

Parenteral nutrition dependency: under parenteral nutrition for at least 3 years with parenteral glycolipidic diet > or = 30% of the total caloric need for age. The parenteral diet should have been stable for at least 3 months.

Parents consent

Exclusion criteria

Over 20% change in caloric daily requirement within the last 6 months before inclusion.

Surgery on digestive tube within the last 3 months. Administration of drugs targeting digestion (decontamination, macrobiotic, gastric dressing, chelating agents of biliary salts) within the last month.

History or presence of tumoral process, leukaemia, minor intracranial hypertension, epiphysiolysis, carpal tunnel syndrome.

Ongoing infection (fever and inflammatory biologic syndrome), progressive inflammatory syndrome.

Heart failure, renal and respiratory insufficiency. Allergy to solvent. Any condition making impossible the follow-up of the patient during the study. Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.