Evidence map›Paper›PMID 36852101›Full record

ArticleContemporary clinical trials communications2023

Can butyrate prevent colon cancer? The AusFAP study: A randomised, crossover clinical trial.

Julie Clarke, Alex Boussioutas, Brooke Flanders, Trevor Lockett, Karen Harrap, Ian Saunders, Patrick Lynch, Mark Appleyard, Allan Spigelman, Don Cameron and 1 more

Open access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 1 synthesis or guideline pooled it, 11 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Review
  5. Review
  6. Review
  7. Review
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors at 7 institutions in 2 countries.

Julie ClarkeCSIRO Health and Biosecurity Adelaide, SA, 5000, Australia.
Alex BoussioutasDepartment of Medicine, Royal Melbourne Hospital, University of Melbourne, Victoria, 3050, Australia.
Brooke FlandersDepartment of Medicine, Royal Melbourne Hospital, University of Melbourne, Victoria, 3050, Australia.
Trevor LockettCSIRO Health and Biosecurity, North Ryde, NSW, 1670, Australia.
Karen HarrapCSIRO Health and Biosecurity, Herston, Brisbane, Queensland, 4006, Australia.
Ian SaundersCSIRO Computational Informatics, Glen, Osmond, SA, 5064, Australia.
Patrick LynchDivision of Internal Medicine, MD Anderson Cancer Center, Houston, TX, 77030, USA.
Mark AppleyardRoyal Brisbane & Women's Hospital, Herston, Queensland, 4029, Australia.
Allan SpigelmanUniversity of New South Wales and St Vincent's Hospital, Sydney, New South Wales, 2010, Australia.
Don CameronRoyal Children's Hospital, Melbourne, Victoria, 3052, Australia.
Finlay MacraeDepartment of Medicine, Royal Melbourne Hospital, University of Melbourne, Victoria, 3050, Australia.
CSIRO Health and Biosecurity · AUThe Royal Melbourne Hospital · AUCommonwealth Scientific and Industrial Research Organisation · AURoyal Brisbane and Women's Hospital · AURoyal Children's Hospital · AUThe University of Texas MD Anderson Cancer Center · USUNSW Sydney · AU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Increased colonic butyrate from microbial fermentation of fibre may protect from colorectal cancer (CRC). Dietary butyrylated high amylose maize starch (HAMSB) delivers butyrate to the large bowel. The objective of this clinical trial (AusFAP) is to evaluate potential chemoprotective effects of HAMSB on polyposis in individuals with a genetic form of colon cancer, Familial Adenomatous Polyposis (FAP). The study is a multi-site, double blind, randomised, placebo-controlled crossover trial undertaken at major hospitals in Australia. After a baseline endoscopy participants consume either 40g/day of HAMSB or placebo (low amylose maize) starch for 26 weeks. After another endoscopic examination participants consume the alternate starch for 26 weeks. A third endoscopy at 52 weeks is followed by 26 weeks' washout and a final endoscopy at 78 weeks. Primary outcome measure is the global large bowel polyp number. Secondary measures include global polyp size counts, and number and size of polyps at two tattoo sites: one cleared of polyps at baseline, and another safely chosen with polyps left in situ during the study. Other secondary outcome measures include the effects of intervention on cellular proliferation in colonic biopsies, faecal measures including short chain fatty acid concentrations, and participants' dietary intakes. Generalized linear mixed models analysis will be used to estimate differences in primary outcomes between intervention and placebo periods. This study represents the first clinical evaluation of the effects of increased colonic butyrate on polyp burden in FAP which, if effective, may translate to lower risk of sporadic CRC in the community. Australian New Zealand Clinical Trials Registry Number: 12612000804886.

Indexed as

ButyrateColorectal cancer (CRC)Familial adenomatous polyposis (FAP)Short chain fatty acids (SCFA)

Identifiers

PMID36852101
PMCPMC9958425
OpenAlexW4320717209

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.