Status:
ACTIVE_NOT_RECRUITING
The ADDapt Diet in Reducing Crohn's Disease Inflammation
Lead Sponsor:
King's College London
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Crohn Disease
Inflammatory Bowel Diseases
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
Crohn's disease (CD) results in chronic intestinal inflammation, is of increasing incidence both in the developed and developing world and has a marked impact on patient quality of life. The prevalenc...
Eligibility Criteria
Inclusion
- Adults aged ≥16 years
- CD diagnosis (defined by standard clinical, histological and radiological criteria) of at least 3 months
- Mildly active disease as defined by:
- Defined by physician assessment that no change in medication is required
- Faecal calprotectin \>150 µg/g OR endoscopic evidence of active luminal disease OR radiological evidence of active luminal disease (by magnetic resonance enterography, or ultrasound) within the last 8 weeks.
- CDAI between 150-250
- Current body weight of ≥50 kg
- Individuals able to give informed consent and willingness to participate
Exclusion
- Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-α agents or other biologics during the preceding 8 weeks, oral 5-ASA during the preceding four weeks. Currently receiving oral prednisolone/budesonide or discontinued within the last 4 weeks, unless they are on a stable dose of 10 mg/day or less prednisolone (3 mg or less budesonide) for at least 4 weeks with the intention to continue this long term.
- Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
- Previous extensive bowel resection, defined as having had \>2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
- Poorly controlled bile acid malabsorption
- Current stoma
- Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week
- Full bowel preparation for a diagnostic procedure in preceding 4 weeks
- Comorbidities including sepsis/fever, diabetes or coeliac disease, or other concomitant serious comorbidity e.g. significant psychiatric, hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease
- Exclusive enteral nutrition in the past 8 weeks
- Assessed as at nutritional risk, as defined by any of the following:
- BMI ≤18.5 kg/m2
- Previous or current eating disorder
- Currently receiving prescribed oral nutritional supplements
- Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian
- Reported pregnancy or lactation
Key Trial Info
Start Date :
September 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 20 2024
Estimated Enrollment :
154 Patients enrolled
Trial Details
Trial ID
NCT04046913
Start Date
September 9 2019
End Date
August 20 2024
Last Update
June 6 2024
Active Locations (1)
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1
King's College London
London, United Kingdom, SE1 9HN