The ADDapt diet in reducing Crohn's disease inflammatio

Recruitment & Eligibility

Status: Ongoing

Sex: All

Target Recruitment: 154

Inclusion Criteria

Current participant inclusion criteria as of 03/02/2022:
1. Adults aged =16 years
2. Crohn's disease diagnosis (defined by standard clinical, histological and radiological criteria) of at least 6 months
3. Mildly active disease as defined by:
3.1 Defined by physician assessment that no change in medication is required
3.2 Faecal calprotectin >150 µg/g
3.3 CDAI between 150-250
3.4 Current body weight of =50 kg
3.5 Individuals able to give informed consent and willingness to participate

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Previous participant inclusion criteria:
1. Adults aged > = 18 years
2. Crohn's disease diagnosis (defined by standard clinical, histological and radiological criteria) of at least 6 months
3. Mildly active disease as defined by:
3.1 Defined by physician assessment that no change in medication is required
3.2 Faecal calprotectin > 150 µg/g
3.3 CDAI between 150-250
3.4 Current body weight of > = 50 kg
3.5 Individuals able to give informed consent and willingness to participate

Exclusion Criteria

1. Changes in dose to azathioprine, 6-mercaptopurine, methotrexate or anti-TNF-a 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.
2. Used rectal 5-ASA or rectal steroids in the preceding 4 weeks
3. Previous extensive bowel resection, defined as having had > 2 intestinal resections, a sub-total colectomy or documented short bowel syndrome
4. Poorly controlled bile acid malabsorption
5. Current stoma
6. Recent use of the following treatments: antibiotics, probiotics, prebiotic or fibre supplements in the preceding four weeks, NSAIDs during the preceding week
7. Full bowel preparation for a diagnostic procedure in preceding 4 weeks
8. 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
9. Exclusive enteral nutrition in the past 8 weeks
10. Assessed as at nutritional risk, as defined by any of the following:
10.1 BMI < = 18.5 kg/m2
10.2 Previous or current eating disorder
10.3 Currently receiving prescribed oral nutritional supplements
11. Following a restrictive diet (e.g. multiple restrictions due to numerous self-reported allergies) as judged by the dietitian
12. Reported pregnancy or lactation

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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