The effects of butyrylated high amylose maize starch (Starplus B) on polyposis in familial adenomatous polyposis patients

Phase 2

Completed

• Conditions: Familial Adenomatous Polyposis; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12612000804886
• Lead Sponsor: Royal Melbourne Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-01
• Study Completion: 2018-05-07
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 49

Inclusion Criteria

1. Medically diagnosed FAP with either an intact colon, or after colectomy with a residual ileorectal anastomosis (IRA) or ileal pouch
2. History of polyp detection at surveillance sigmoidoscopies or colonoscopies
3. Generally in good health
4. Available for the duration of the study

Exclusion Criteria

1.Intolerant to high fibre products
2.Reported lactating, pregnant or wish to become pregnant during the study. If a participant becomes pregnant during the trial they will be withdrawn
3.Reported use of nonsteroidal anti-inflammatory drugs, aspirin or probiotics
4.Use of other medication or supplement that in the opinion of the gastroenterologist may interfere with polyp development or bowel or microbiota function for 2 months prior to and during the clinical intervention. Use of anti-diarrhoeal medication(s) is allowed as required
5.Use of antibiotics for 2 months prior to the commencement of the trial
6.Use of other experimental chemopreventative agents, including EPA, tumeric and curcumin for 6 months prior to and during the trial
7.Colonic or rectal surgery likely within 18 months.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Aim 1: Assess the efficacy of Starplus B at reducing polyp incidence <br>(i) In a defined area after appropriate clearance at sigmoidoscopy/colonoscopy, or<br>(ii) causing regression of small polyps left in situ in another defined area, and<br>(iii) in general throughout the large bowel<br>This will be done using colonoscopy/sigmoidoscopy procedures and video analysis.[Week 0, Week 26, Week 52, Week 78];Aim 2: Determine the effect of Starplus B on molecular characteristics of typical polyps and on macroscopically normal adjacent rectal mucosa:<br>a. Measure rates of apoptosis in polyps and adjacent mucosa<br>b. Measure proliferation in polyps and adjacent mucosa<br>c. Measure surrogate markers of DNA damage in polyps and adjacent mucosa[Week 0, Week 26, Week 52, Week 78]

Secondary Outcome Measures

Name	Time	Method
Aim 2.1: Determine the proportion of esterified butyrate released in the gastrointestinal tract of FAP patients consuming Starplus B. This will be done by analysing faecal samples, using standard distillation procedures and gas chromatography, collected from 60 participants.[Week 0, Week 4, Week 26, Week 30, Week 52];Aim 2.2: Collect information on the normal diet of FAP patients, their baseline nutrient intake and the impact of supplementation on their diet. This will be done using a 24 hour diet recall.[Week 0, Week 12, Week 38];Aim 2.3: Determine the effects of consumption of Starplus B on gastrointestinal function and quality of life of FAP<br>patients. This will be done using a validated assessment tool for evaluating the quality of life and distress for gastrointestinal symptons (Eypasch et al., 1995 Gastrointestinal quality of life index: development, validation and application of a new instrument; British Journal of Surgery, 82, 216-222).[Week 0, Week 12, Week 26, Week 38, Week 52, Week 78]