Apple and Colitis study (AppleCo)

Not Applicable

Recruiting

• Conditions: ulcerative colitis; Inflammatory and Immune System - Other inflammatory or immune system disorders; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12623001090606
• Lead Sponsor: oha Nasef

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-10-17
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

•Established diagnosis of UC for at least 6-months
•Faecal calprotectin of greater than 200 µg/g
•male or female aged between 18 and 60
•Ability to complete web-based questionnaires in English
•Must have an email address and access to a computer and internet. Must have time to complete online weekly questionnaires (~30 minutes each).

Exclusion Criteria

•Those who are in remission (P-SCCAI score less than or equal to 2) and disease inactive (MIBDI score)
•Those with severe disease activity
•History of colectomy, total colectomy or colostomy
•Probiotic use
•Pregnant or breast feeding
•Known allergies or hypersensitivity to apples.
•Any significant comorbidities
•Antibiotic therapy in the last 4 weeks prior to inclusion into the study

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Intestinal inflammation assessed by fecal calprotectin [ Weekly for 6 weeks post-enrollment ]

Secondary Outcome Measures

Name	Time	Method
Quality of Life: Crohn's and Ulcerative Colitis Questionnaire-32 (CUCQ-32) <br><br>[ Fortnightly for 6 weeks post-enrollment ];Faecal short chain fatty acids [ Baseline and 5 weeks post-enrollment];Gut microbiota determined by 16s RNA of faecal samples[ Baseline, 5 weeks and 6 weeks post-enrolment];IBD symptoms (IBDSI-SF) score <br>[ Weekly for 6 weeks post-enrollment ];Functional gastrointestinal symptoms score (GSRS) [ Weekly for 6 weeks post-enrollment]