utrition support in inactive Crohn's disease

Not Applicable

Completed

• Conditions: utritional support for inactive Crohn's disease; Digestive System; Crohn disease, unspecified

• Registration Number: ISRCTN50980108
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-01-31
• Study Completion: 2014-09-30
• Last Update Posted: 19 October 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 7

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified