Nutritional support for inactive Crohn's disease Digestive System Crohn disease, unspecified
Conditions
Interventions
Participants will be randomised to two groups:
1. Intervention group: Receives standard care in the form of written information. In addition, they will receive dietary counselling indi
Sponsors
King's College London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged =18 years 2. Diagnosis of Crohn's disease for duration of at least 6 months confirmed by standard clinical, histological and radiological criteria 3. Crohn's disease in remission as defined by Harvey Bradshaw score of < 5 4. Stable medications (see exclusion criteria), no recent surgery (see exclusion criteria) and stable symptoms for at least 2 months 5. BMI < 20 kg/m2 6. A willingness to participate 7. Individuals able to give informed consent
Exclusion criteria
Exclusion criteria: 1. Patients with active Crohn's disease 2. Use of the following treatments: antibiotics, non-steroidal anti-inflammatory drugs (NSAIDs) during the preceding week 3. Currently taking steroids 4. Recent changes in dose to the following treatments: azathioprine, 6-mercaptopurine, methotrexate or a-TNF agents during the preceding 12 weeks, oral 5-aminosalicylate (5-ASA) or steroids during the preceding 4 weeks 5. Previous pan-proctocolectomy, pure perianal disease or short bowel syndrome 6. Stenotic disease 7. Sepsis or fever 8. Diabetes or coeliac disease (by serology and/or duodenal biopsy) 9. Other concomitant serious comorbidity e.g. significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease 10. Pregnancy or lactation 11. Taking any medications with the potential to influence gastrointestinal symptoms unless taking a long-term stable dose that is unlikely to change or stop during the trial 12. Currently receiving oral nutritional supplements, enteral or parenteral nutrition, or having received dietary counselling or oral nutritional supplements, enteral or parenteral nutrition, in the previous 3 months prior to study commencement 13. Non fluent English
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate, retention, attrition and feasibility 2. Eligibility criteria including screening for under-nutrition, study design and methodology 3. Qualitative interviews on experience of participation Measured by Interview Acceptability Interview at at baseline and two months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Nutritional outcome measures (measured by anthropometry and food record charts) 2. Clinical Outcomes (markers of disease activity and a Stool and Symptom Diary) 3. Patient centred outcome measures (measured by questionnaires) All completed at baseline and after two months | — |
Countries
United Kingdom
Outcome results
None listed