CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease

• Register: ClinicalTrials.gov
• Last refreshed on: 29 January 2024
• Main ID: NCT03171246
• Date of registration: 17/05/2017
• Prospective Registration: Yes
• Primary sponsor: NHS Greater Glasgow and Clyde
• Public title: CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease
• Scientific title: An Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's Disease
• Date of first enrolment: October 23, 2017
• Target sample size: 60
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/ct2/show/NCT03171246
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

United Kingdom

Contacts

• Name: Richard Hansen, MB ChB MRCPCH PhD
• Affiliation: NHS Greater Glasgow and Clyde

Key inclusion & exclusion criteria

Inclusion Criteria:

- previously diagnosed patients with active luminal CD [paediatric (6-15 years old)
wPCDAI=12.5) or adult (16-65 years old) HBI=5]

- in need of starting induction treatment

Exclusion Criteria:

- pregnancy

- use of antibiotics currently or during the past 1 month

- major change in inflammatory bowel disease (IBD) induction or maintenance therapy in
the preceding 3 months (defined as change in type of treatment)

- minor change in IBD induction or maintenance therapy in the preceding 1 month (defined
as adjustment of treatment dosage)

- enrolment in other studies investigating the efficacy of other novel therapies in
disease activity

- disease severity sufficient to warrant hospital admission

- food allergies incompatible with CD-TREAT (e.g. cow's milk allergy)



Age minimum: 6 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn Disease

Intervention(s)

Dietary Supplement: Solid food-based intervention

Primary Outcome(s)

Crohn's Disease activity [Time Frame: Baseline to 8 weeks]

Secondary Outcome(s)

Weight [Time Frame: Baseline to 8 weeks]

Blood inflammatory marker [Time Frame: Baseline to 8 weeks]

Body Mass Index [Time Frame: Baseline to 8 weeks]

Quality of Life [Time Frame: Baseline to 8 weeks]

Faecal calprotectin [Time Frame: Baseline to 8 weeks]

Height [Time Frame: Baseline to 8 weeks]

Secondary ID(s)

GN17GA213P

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

University of Glasgow