CD-TREAT Diet: a Novel Therapy for Active Luminal Crohn's Disease
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|ClinicalTrials.gov Identifier: NCT03171246|
Recruitment Status : Unknown
Verified April 2018 by NHS Greater Glasgow and Clyde.
Recruitment status was: Recruiting
First Posted : May 31, 2017
Last Update Posted : April 9, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Dietary Supplement: Solid food-based intervention||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open Label Pilot Study of the CD-TREAT Diet as a Novel Therapy for Active Luminal Crohn's Disease|
|Actual Study Start Date :||October 23, 2017|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2019|
Experimental: CD-TREAT (Solid food-based intervention)
Solid food-based dietary intervention replicating composition of exclusive enteral nutrition (EEN).
Daily for up to 12 weeks.
Dietary Supplement: Solid food-based intervention
Individually tailored energy content according to age/activity
- Crohn's Disease activity [ Time Frame: Baseline to 8 weeks ]Change in Harvey Bradshaw Index (HBI) (adults) or weighed Paediatric Crohn's Disease Activity Index (wPCDAI) (children) score
- Faecal calprotectin [ Time Frame: Baseline to 8 weeks ]Change in faecal calprotectin level
- Blood inflammatory marker [ Time Frame: Baseline to 8 weeks ]Change in blood inflammatory marker level
- Height [ Time Frame: Baseline to 8 weeks ]Change in height (cm)
- Quality of Life [ Time Frame: Baseline to 8 weeks ]Change in Self-Administered Inflammatory Bowel Disease Questionnaire (SIBDQ) (adults) and IMPACT III (children) score
- Weight [ Time Frame: Baseline to 8 weeks ]Change in weight (kg)
- Body Mass Index [ Time Frame: Baseline to 8 weeks ]Change in Body Mass Index (BMI)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03171246
|Contact: Vaios Svolos, BSc MSc||07450 546 email@example.com|
|Contact: Richard Hansen, MB ChB MRCPCH PhD||0141 451 firstname.lastname@example.org|
|Glasgow Royal Infirmary||Recruiting|
|Glasgow, Scotland, United Kingdom, G31 2ER|
|Royal Hospital for Children||Recruiting|
|Glasgow, Scotland, United Kingdom, G51 4TF|
|Principal Investigator:||Richard Hansen, MB ChB MRCPCH PhD||NHS Greater Glasgow and Clyde|