Effectiveness of liquid special diet to induce gut healing when used as a sole nutrition for newly diagnosed children with Crohn's Disease.

Not Applicable

Recruiting

• Conditions: Crohn's Disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12612001032842
• Lead Sponsor: Dr.Zubin Grover

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-09-25
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

New Diagnosis of Paediatric Crohn's disease

Exclusion Criteria

Exclusion criteria included previous exposure to: steroids, conventional Immunomodulators, biological agents; and inability to tolerate oral or Nasogastric (NG) tube EEN for a minimum of 6 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary end points of the study are to determine efficacy of EEN for inducing early clinical, biochemical, mucosal and transmural remission at 8 weeks. <br><br>Measurement at diagnosis and 8 weeks:<br><br>PCDAI= Clinical and Biochemistry including CRP<br>BMI Z= Growth measurements<br>Mucosal healing= Endoscopic Scoring ( Colonoscopy)<br>Transmural Healing = MR Enterography[At Diagnosis and 8 weeks.];Relate early endoscopic response to subsequent clinical outcomes, specifically endoscopic confirmed relapse, hospitalisation, need to commence biological agent and surgical resection[12 and 24 months.]

Secondary Outcome Measures

Name	Time	Method
After an initial expected enrolment of 20 children interim mechanistic analyses will be done to refine the outlined hypotheses. <br>Additional 30 patients will be enrolled subsequently to identify the changes in mucosal cytokine T regulatory profiles, faecal and mucosal microbiota, genotypes of EEN responders versus EEN non responders and versus those electing for steroids to better understand mechanism of EEN induced remission , target dietary interventions and develop risk stratification of patients.<br><br>24 months<br><br>Faecal microbiome : Pyrosequencing for microbiome<br>Mucosal biopsy for Cytokines, T reg & microbiome: ELISA , Microarray, Immunohistochemistry <br>Blood T reg profile: Flow cytometry[24 months]