Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 20 April 2015
• Main ID: NCT01647412
• Date of registration: 19/07/2012
• Prospective Registration: No
• Primary sponsor: Columbia University
• Public title: Growth Hormone and Exclusion Diet Therapy in Juvenile Crohn's Disease
• Scientific title: Growth Hormone and Nutrition Therapy in Juvenile Crohn's Disease, a Randomized Clinical Trial
• Date of first enrolment: March 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01647412
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: Alfred E Slonim, MD
• Affiliation: Columbia University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Ability to provide written informed consent

- Age 10-17 years

- Diagnosis of CD as determined by standard clinical, radiological, and pathological
criteria

- Clinical evidence of CD for more than 2 years

- Moderate to severely active CD, as defined by a PCDAI score > 30 and < 65

- May continue use of aminosalicylates, antibiotics, immunomodulators, including
azathioprine, 6-mercaptopurine and methotrexate, as well as the monoclonal antibody
drug, infliximab, if prescribed for at least 4 months and receiving stable doses for
at least 2 months prior to baseline visit

- May continue the use of prednisone if prescribed for at least 6 weeks prior to
baseline visit

- Meets the following hematological and biochemical requirements:

- HGB > 8.5 g/dl

- WBC > 3.5 x 109/L

- Neut. > 1.5 x 109

- Plats > 100 x 109/L

- SGOT & Alk Phos not > 2 times the upper limit of normal

Exclusion Criteria:

- Acute critical illness

- Acute, chronic, or latent infection

- Active neoplasia and/or history of neoplastic disease of any origin other than basal
cell carcinoma that has been removed

- Evidence of a systemic disorder unrelated to CD involving hepatic, gastrointestinal,
pulmonary, cardiac, renal, hematologic, endocrine, central or peripheral nervous
systems

- Use of parenteral corticosteroids or corticotrophin within 2 months of baseline visit

- Use of another investigational agent within 3 months of baseline visit

- Long-term anti-coagulant therapy or use of any anti-coagulant medication, including
NSAIDs or ASA, within 2 weeks of screening visit

- Pregnancy (positive pregnancy test)

- Positive stool culture for enteric pathogens, pathogenic ova, parasites or
clostridium difficile toxin

- Any condition that the investigator believes would pose significant harm to the
subject if the investigational therapy were initiated

- Diagnosis of short bowel syndrome and also on TPN

- Presence of an ostomy, symptomatic stenosis or ileal stricture, or severe intestinal
stricture, proctocolectomy, total colectomy or stoma

- Patients in imminent need of surgery due to active gastrointestinal bleeding fixed
stenosis, intermittent obstruction or obstructive event within 2 months prior to
screening.

- Patients who underwent CD surgery within 2 months of screening



Age minimum: 10 Years
Age maximum: 17 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Other: Placebo Growth Hormone

Dietary Supplement: Nutraceutical Combination

Drug: Growth Hormone

Other: Exclusion Diet

Primary Outcome(s)

Proportion of Patients in remission [Time Frame: 26 weeks and 52 weeks]

Secondary Outcome(s)

Bone Mineral Density (BMD) [Time Frame: Baseline and 52 weeks]

Secondary ID(s)

AAAJ8306

Source(s) of Monetary Support

Please refer to primary and secondary sponsors