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

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ClinicalTrials.gov Identifier: NCT03171246
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : April 9, 2018
Sponsor:
Collaborator:
University of Glasgow
Information provided by (Responsible Party):
NHS Greater Glasgow and Clyde

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.


Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: Solid food-based intervention Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Faecal calprotectin [ Time Frame: Baseline to 8 weeks ]
    Change in faecal calprotectin level

  2. Blood inflammatory marker [ Time Frame: Baseline to 8 weeks ]
    Change in blood inflammatory marker level

  3. Height [ Time Frame: Baseline to 8 weeks ]
    Change in height (cm)

  4. Quality of Life [ Time Frame: Baseline to 8 weeks ]
    Change in Self-Administered Inflammatory Bowel Disease Questionnaire (SIBDQ) (adults) and IMPACT III (children) score

  5. Weight [ Time Frame: Baseline to 8 weeks ]
    Change in weight (kg)

  6. Body Mass Index [ Time Frame: Baseline to 8 weeks ]
    Change in Body Mass Index (BMI)



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Ages Eligible for Study:   6 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

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


Contacts
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Contact: Vaios Svolos, BSc MSc 07450 546 251 v.svolos.1@research.gla.ac.uk
Contact: Richard Hansen, MB ChB MRCPCH PhD 0141 451 6543 richard.hansen@nhs.net

Locations
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United Kingdom
Glasgow Royal Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G31 2ER
Royal Hospital for Children Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
University of Glasgow
Investigators
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Principal Investigator: Richard Hansen, MB ChB MRCPCH PhD NHS Greater Glasgow and Clyde

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT03171246     History of Changes
Other Study ID Numbers: GN17GA213P
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: April 9, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Participants will be asked to provide written consent for their anonymised data to be made available to public data repositories.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NHS Greater Glasgow and Clyde:
dietary intervention

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Phenobarbital
Anticonvulsants
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
GABA Agents
Cytochrome P-450 CYP2B6 Inducers
Cytochrome P-450 Enzyme Inducers
Cytochrome P-450 CYP3A Inducers