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.

Condition	Intervention	Phase
Short Bowel Syndrome	Drug: rhGH	Phase III

Further Study Details: 

Primary Outcomes: 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
Secondary Outcomes: Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.; To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4) and at the end of study (month 14); To quantify the variation in body composition (auxology and biphotonic absorptiometry) at the end of the randomized study (month 4) and at the end of study (month 14); To evaluate the tolerance and safety of rhGH at the end of the randomized study (month 4) and at the end of study (month 14.
Expected Total Enrollment:  20

Ages Eligible for Study:  3 Years   -   18 Years,  Genders Eligible for Study:  Both

Criteria

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 glyco-lipidic diet  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, carpian 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 non-affiliated to social security.
• Person participating in another clinical trial or taking another medication under investigation within one month before inclusion.

Please refer to this study by ClinicalTrials.gov identifier  NCT00169637

alain LACHAUX, MD      33 472 110 390    alain.lachaux@chu-lyon.fr

France
      Alain LACHAUX, Lyon,  69437,  France

Study chairs or principal investigators

Alain LACHAUX, MD,  Principal Investigator,  Hospices Civils de Lyon   

Study ID Numbers:  2002.301
Last Updated:  September 14, 2005
Record first received:  September 12, 2005
ClinicalTrials.gov Identifier:  NCT00169637
Health Authority: France: Afssaps - French Health Products Safety Agency
ClinicalTrials.gov processed this record on 2005-09-20