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

NCT03171246 | Completed

• 1 other identifier: GN17GA213P
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

Crohn's disease (CD) is a chronic inflammatory condition of the gut with severe complications. There is strong evidence to suggest that diet and gut bacteria are key components in the onset, perpetuation and management of CD. An 8-week exclusive liquid diet (EEN) without any normal food is the best treatment for paediatric CD. The mode of action of EEN remains unknown, but according to recent publications, the modulation of the gut bacteria drives its therapeutic properties. While successful, EEN is a challenging therapy to follow. Half of the paediatric EEN patients will require a nasogastric tube to support treatment, its use in adults is limited, and the need for a more palatable diet is very well described. Based on these findings, a non-liquid and more acceptable dietary treatment was recently devised called CD-TREAT (Crohn's Disease TReatment-with-EATing) diet. CD-TREAT, which is a solid food-based diet designed to replicate the nutrients and food ingredients composition of EEN, was recently tested in healthy adults and a rat model of colitis. In order to pilot CD-TREAT diet as a CD induction treatment, 10 children and 10 adults with active luminal CD will be recruited. Once consented, baseline blood, urine and faecal samples will be collected and the CD-TREAT prescribed for a maximum of 12 weeks. Another 3 blood, urine and faecal samples will be requested during the 12 weeks. All the foods/meals of the CD-TREAT diet will be purchased and delivered to the participants' house by the researcher and the meals which need cooking will be pre-prepared by a sub-contracted catering company. Blood and faecal inflammatory biomarkers will be measured, the disease activity assessed with routinely used clinical indices and the faecal bacteria and its metabolites characterised.

Conditions

Crohn Disease

Keywords

dietary intervention

Outcome Measures

Primary Outcomes (1)

• Crohn's Disease activity

  Change in Harvey Bradshaw Index (HBI) (adults) or weighed Paediatric Crohn's Disease Activity Index (wPCDAI) (children) score

  Baseline to 8 weeks

Secondary Outcomes (6)

• Faecal calprotectin

  Baseline to 8 weeks

• Blood inflammatory marker

  Baseline to 8 weeks

• Height

  Baseline to 8 weeks

• Quality of Life

  Baseline to 8 weeks

• Weight

  Baseline to 8 weeks

Study Arms (1)

CD-TREAT (Solid food-based intervention)

EXPERIMENTAL

Solid food-based dietary intervention replicating composition of exclusive enteral nutrition (EEN). Daily for up to 12 weeks.

Dietary Supplement: Solid food-based intervention

Interventions

Solid food-based intervention DIETARY_SUPPLEMENT

Individually tailored energy content according to age/activity

CD-TREAT (Solid food-based intervention)

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (2)

Glasgow Royal Infirmary

Glasgow, Scotland, G31 2ER, United Kingdom

Location

Royal Hospital for Children

Glasgow, Scotland, G51 4TF, United Kingdom

Location

Related Publications (1)

• Svolos V, Hansen R, Nichols B, Quince C, Ijaz UZ, Papadopoulou RT, Edwards CA, Watson D, Alghamdi A, Brejnrod A, Ansalone C, Duncan H, Gervais L, Tayler R, Salmond J, Bolognini D, Klopfleisch R, Gaya DR, Milling S, Russell RK, Gerasimidis K. Treatment of Active Crohn's Disease With an Ordinary Food-based Diet That Replicates Exclusive Enteral Nutrition. Gastroenterology. 2019 Apr;156(5):1354-1367.e6. doi: 10.1053/j.gastro.2018.12.002. Epub 2018 Dec 11.

  PMID: 30550821 DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Richard Hansen, MB ChB MRCPCH PhD

  NHS Greater Glasgow and Clyde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 31, 2017
• Study Start: October 23, 2017
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share

Locations

GB (2)