Short Bowel Syndrome
Conditions
Keywords
Short bowel syndrome, Growth hormone, Children
Brief summary
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.
Interventions
DRUGrhGH
Sponsors
Hospices Civils de Lyon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | 4 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation. | 6 months | — |
| To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4) | 4 months | — |
| To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14) | 14 months | — |
| To quantify the variation in body composition (auxology) at the end of the randomized study (month 4) | 4 months | — |
| To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4) | 4 months | — |
| To quantify the variation in body composition (auxology) at the end of study (month 14) | 14 months | — |
| To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14) | 14 months | — |
| number of adverse events | 4 months | — |
| number of adverse events glucose intolerance | 4 months | — |
| number of adverse event | 14 months | To evaluate the tolerance of rhGH at the end of study (month 14). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORAlain LACHAUX, MD
Hospices Civils de Lyon
Outcome results
None listed