Investigating a novel therapeutic diet for ulcerative colitis

Not Applicable

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12624000916549
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-29
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

mild to moderate ulcerative colitis
- active disease (either left-sided or extensive UC) as evidenced sonographically, faecal calprotectin >250 and where available, endoscopy results performed in the last 3 months indicate total Mayo score of 3-10
- on stable medical therapy for >1 month
- naïve to formal dietetic intervention

Exclusion Criteria

- Severe UC, indeterminate colitis or Crohn’s disease
- Presence of other GI co-morbidities (e.g. coeliac disease)
- Presence of clinically significant haematological abnormalities
- Prior gastrointestinal surgeries
- Pregnancy, trying to get pregnant and breastfeeding
- Current use of corticosteroids
- Dietary restrictions, food allergies, intolerances or aversions, that would interfere with consuming intervention foods (e.g. food allergy, veganism, lacto-ovo vegetarianism)
- Individuals not on a stable diet for at least 4 weeks

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in faecal calprotectin as a marker of colonic inflammation[Stool samples will be analysed for calprotectin concentrations using Calpro Easy Extract device and via Enzyme-linked Immunosorbent Assay (ELISA) kit (CAL0100, CALPRO AS; Lysaker). Baseline and end of 4-week treatment]