Nutrition support in inactive Crohn's disease

• Register: ISRCTN
• Last refreshed on: 19 October 2020
• Main ID: ISRCTN50980108
• Date of registration: 31/01/2014
• Prospective Registration: Yes
• Primary sponsor: King's College London (UK)
• Public title: Nutrition support in inactive Crohn's disease
• Scientific title: Detecting and managing undernutrition in adults with inactive Crohn's Disease: feasibility randomised comparative trial of oral nutritional support
• Date of first enrolment: 01/02/2014
• Target sample size: 24
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN50980108
• Study type: Interventional
• Study design: Feasibility randomised comparative trial: single centre two-armed parallel groups (Treatment)
• Phase: Not Applicable

Countries of recruitment

United Kingdom

Contacts

• Name: Kevin Whelan

Key inclusion & exclusion 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:
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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Nutritional support for inactive Crohn's disease
Digestive System
Crohn disease, unspecified

Intervention(s)

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 individually tailored to increase dietary intake by 600 kcal/day over a period of two months.
2. Comparison group: Standard care only

Primary Outcome(s)

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 Outcome(s)

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

Source(s) of Monetary Support

King’s College London

Ethics review

Status:
Approval date:
Contact:

NRES Committee North West Liverpool East, ref: 13/NW/0854 - approval pending

Results

• Results available: Yes
• Date Completed: 30/09/2014