The purpose of this study is to determine whether taking a growth hormone (GH) drug called somatropin causes the intestine of a person with Crohn’s disease (CD) to heal faster when compared to a person with Crohn’s disease that does not receive growth hormone drug.
A Phase II Randomized Trial of Growth Hormone Therapy in Pediatric Crohn’s Disease.
- Crohn’s Disease
Treatment, Randomised, Open Label, Active Control, Parallel Assignment, Efficacy Study.
Primary Outcome Measures:
- The primary endpoint will be the CD histologic index of severity (CDHIS)
Secondary Outcome Measures:
- Serum IGF-1
- Colon crypt epithelial cell (CEC) proliferation labeling index
- IMPACT III
- Paediatric Crohn’s Disease Activity Index
- Total corticosteroid use
- Intra-abdominal fat
- Height velocity
- Fecal calprotectin
Eligibility & Criteria
- Ages Eligible for Study: 5 years and older
- Genders Eligible for Study: Both
- Accepts Healthy Volunteers: No
- Ability to provide written informed consent
- Age ≥ 5 years.
- Diagnosis of Crohn’s disease (CD) with ileo-colonic involvement as determined by standard clinical, radiological, and pathological criteria.
- Moderate to severely active CD as defined by a PCDAI (Paediatric Crohn’s Disease Activity Index) ≥ 30.
- Currently taking prednisone or budesonide at starting dose (not tapering)
- May continue stable doses of AZA/6-MP, methotrexate, and/or mesalamine at entry.
- For the 52 week extension, baseline bone age ≤ 12 years for girls and ≤ 13 years for boys.
- For the 52 week extension phase, remission or mild Crohn’s disease as determined by a PCDAI < 30.
- Acute critical illness
- Active neoplasia
- Diabetes mellitus
- History of intracranial lesion and/or neoplasia
- Severe disease requiring hospitalisation for treatment
- Current therapy with infliximab as this may independently rapidly reduce clinical disease activity and promote mucosal healing
- Use of prednisone or budesonide and in tapering phase
- Family history of colorectal cancer before age 50
- Personal or familial history of familial polyposis syndrome
- Pregnancy (positive pregnancy test) prior to randomisation
- Any other condition that the investigator believes would pose a significant hazard to the subject if the investigational therapy were initiated
- Participation in another simultaneous medical investigation or trial other than the Paediatric IBD (Inflammatory Bowel Disease) registry.
Lee Denson, MD
Children’s Hospital Medical Center, Cincinnati
Cincinnati Children’s Hospital Medical Center