Nutrition support in inactive Crohn's disease
| ISRCTN | ISRCTN50980108 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN50980108 |
| Protocol serial number | 1 |
| Sponsor | King's College London (UK) |
| Funder | King’s College London |
- Submission date
- 24/01/2014
- Registration date
- 31/01/2014
- Last edited
- 05/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Plain English summary of protocol
Background and study aims
People with Crohn's disease (a long-term condition causing inflammation of the lining of the digestive system) may experience a number of nutritional deficiencies even at times when their disease is not active. This study aims to look at the feasibility of carrying out a study to compare dietary counselling to standard written information to manage under-nutrition in people with Crohn's disease.
Who can participate?
Patients aged 18-65 with Crohn's disease in its inactive state attending outpatient appointments at Guy's and St Thomas' NHS Trust.
What the study involve?
Participants are randomly allocated to one of two groups. Both groups receive standard care in the form of written dietary information increasing portion size, meal frequency, food choice, nutrient density and food fortification. One group also receives dietary counselling tailored to provide an additional 600 kcal/d for a period of two months. At the end of the study, interviews are conducted to measure participant acceptability.
What are the possible benefits and risks of participating?
The participants may view the opportunity to receive well-established dietary counselling as a benefit of the study. The main disadvantages are the burden of participating in a study, the need to make dietary changes and the need to visit the research centre to carry out measurements on two occasions.
Where is the study run from?
Guy's and St Thomas' NHS Trust (UK)
When is the study starting and how long is it expected to run for?
February 2014 to May 2014
Who is funding the study?
King's College London (UK)
Who is the main contact?
Sheena Visram
sheena.visram@kcl.ac.uk
Contact information
Scientific
Diabetes and Nutritional Sciences Division
King's College London
4th Floor Franklin-Wilkins Building
150 Stamford Street
London
SE1 9NH
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Feasibility randomised comparative trial: single centre two-armed parallel groups |
| Secondary study design | Randomised parallel trial |
| Study type | Participant information sheet |
| Scientific title | Detecting and managing undernutrition in adults with inactive Crohn's Disease: feasibility randomised comparative trial of oral nutritional support |
| Study objectives | The feasibility study will allow methodology, study design and outcome measures to be tested and a key outcome will be to measure patients' perceptions of the interventions, design and outcomes. This will provide essential information to inform the design of an adequately powered multicentre trial of oral nutritional support. |
| Ethics approval(s) | NRES Committee North West Liverpool East, ref: 13/NW/0854 - approval pending |
| Health condition(s) or problem(s) studied | Nutritional support for inactive Crohn's disease |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Recruitment rate, retention, attrition and feasibility |
| Key secondary outcome measure(s) |
1. Nutritional outcome measures (measured by anthropometry and food record charts) |
| Completion date | 30/09/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 24 |
| Total final enrolment | 7 |
| Key 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 |
| Key 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 α-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 |
| Date of first enrolment | 01/02/2014 |
| Date of final enrolment | 01/05/2014 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
SE1 9NH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/10/2020: The final enrolment number has been added.
07/12/2017: No publications found, verifying study status with principal investigator.
