Protein digestibility of bread made from enzyme treated flour in adults with an ileostomy

Not Applicable

Completed

• Conditions: Gut health; Inadequate nutrition; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12620000166976
• Lead Sponsor: CSIRO Health and Biosecurity

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-02-17
• Study Completion: 2020-06-22
• Last Update Posted: 13 March 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

•Adult male or female
•Aged 20-80 years inclusive.
•Health professional confirmation of minimal terminal ileum (up to 10 cm) removed more than 1 year ago and have a conventional and well-functioning permanent ileostomy deemed fit for the study intervention (confirmed by GP).
•Understand the study requirements, including digesta collections and willing to adhere closely to prescribed food consumption and alcohol restrictions as per the research protocol.

Exclusion Criteria

•History of drug or alcohol abuse (i.e. > 14 serves alcohol/wk).*
•History of smoking within the 6 months prior to the study.
•Participation in a dietary intervention study within 30 days of commencement of this study.
•A current presence of having gastrointestinal, renal, hepatic disease, coeliac disease, irritable bowel disease or, inflammatory bowel disease including Crohn’s disease and ulcerative colitis*
•Use of any medication within the last 3 months that in the opinion of the investigator could interfere with the study or medications likely to modulate small intestinal function (See protocol for list of medications).
•Definite or suspected personal history or family history of adverse events or intolerance to bread or foods made from wheat.*
•Person considered by the investigator to be unwilling, unlikely or unable to comprehend or comply with the study protocol and restrictions.
•Unwilling or unable to collect ileal effluent as required.
* confirmed by trained Clinic Team Member; no clinical testing will be conducted to diagnose/confirm medical history.

Study & Design

• Study Type: Interventional
• Study Design: Not specified