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NCT Number: NCT00169637

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

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.

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Key information

Conditions

Short Bowel Syndrome Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Malabsorption Syndromes Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

3 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Alain LACHAUX

Lyon, 69437, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

rhGH

Drug

Primary outcomes

  1. 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

Secondary outcomes

  1. Evaluate the persistent efficacy (remaining rate of weaning off) 6 months after rhGH discontinuation.

    Time frame: 6 months

  2. To evaluate the intestinal absorption (input-output within 3 days) at the end of the randomized study (month 4)

    Time frame: 4 months

  3. To evaluate the intestinal absorption (input-output within 3 days) at the end of study (month 14)

    Time frame: 14 months

  4. To quantify the variation in body composition (auxology) at the end of the randomized study (month 4)

    Time frame: 4 months

  5. To quantify the variation in body composition (biphotonic absorptiometry) at the end of the randomized study (month 4)

    Time frame: 4 months

  6. To quantify the variation in body composition (auxology) at the end of study (month 14)

    Time frame: 14 months

  7. To quantify the variation in body composition ( biphotonic absorptiometry) at the end of study (month 14)

    Time frame: 14 months

  8. number of adverse events

    Time frame: 4 months

  9. number of adverse events glucose intolerance

    Time frame: 4 months

  10. number of adverse event

    Time frame: 14 months

    To evaluate the tolerance of rhGH at the end of study (month 14).

  11. number of adverse events glucose intolerance

    Time frame: 14 months

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Important dates

Study start
2006
Primary completion
2008
Study completion
2008
First posted
Sep 15, 2005
Registry last updated
May 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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