COLONiC: Consequences of OLive Oil replacemenNt on ulcerative Colitis

Not Applicable

• Conditions: lcerative Colitis; Ulcerative Colitis; Oral and Gastrointestinal - Inflammatory bowel disease; Inflammatory and Immune System - Autoimmune diseases

• Registration Number: ACTRN12619000150145
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-01
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 56

Inclusion Criteria

For Individuals with Ulcerative Colitis:
1) Aged >= 18 at the time of recruitment
2) Ulcerative colitis (UC) >3 months duration of any extent .
3) Willingness to participate in the study protocol, randomization and provide informed consent

For non-IBD subjects:
1) Aged >= 18 years at the time of recruitment
2.) Willing to be randomized into one of the two study arms and participate in the intervention prescribed
3) Stable medication. All drugs to be held at constant dose during the study and no changes to medication in the preceding 4 weeks.

Exclusion Criteria

For individuals with Ulcerative Colitis (UC)
1) Currently living with other Inflammatory Bowel Disease not defined as UC (e.g. Crohn's disease, non specific IBD)
2) History of fecal microbiota transplantation
3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing
4) Planned major surgery within the first 3 months after randomization
5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks
6) Changes to UC medical therapy within 4 weeks of study initiation
7) Pregnant or female planning pregnancy for the first 3 months post randomisation
8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason
9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract
10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional
11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase)
12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation.
13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week..
14) Participation in another clinical trial for with concurrent participation is deemed inappropriate.

For participants in the non-IBD group:
1) History of Inflammatory Bowel Disease of any description (including remission)
2) History of fecal microbiota transplantation
3) Significant prior gastrointestinal surgery (e.g., colon resection, colectomy) or clinical evidence of any comorbid chronic disease that may interfere with the patient’s ability to enter the trial and undertake the testing
4) Planned major surgery within the first 3 months after randomization
5) Antibiotic/anti-tuberculosis treatment for any reason during the study period or in the preceding 4 weeks
6) Changes to UC medical therapy within 4 weeks of study initiation
7) Pregnant or female planning pregnancy for the first 3 months post randomisation
8) Diagnosed allergy or intolerance towards olives or olive based products, or avoidance of olive based products for any other reason
9) Daily consumption of olives or olive based products including spreads, oils, marinated olives, tapenade, or supplements such as olive leaf extract
10) Those undertaking a specialized diet in which the intervention would be deemed inappropriate (e;g;, fat reduction or low fat diet) or those whose diet is currently under the supervision of a relevant medical professional
11) Medical nutrition therapy under supervision of a healthcare professional (e.g., texture modifciation, progression to a full diet post hospitaliation, FODMAP or RPA elimination diet challenge phase)
12) Use of tube or enteral feeding, elemental diet, or parenteral nutrition within 4 weeks of study initiation.
13) Regular consumption of takeaway or restaurant meals more than 3 days a week or 9 meals a week..
14) Participation in an

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
lcerative Colitis disease activity as determined via the partial Mayo scoring Index[Weekly from baseline to 8 weeks];Gut microbiota variety and richness via faecal samples (composite outcome based on gut bacteria profiles)[Baseline, 4 weeks, 8 weeks]