Evidence map›Paper›PMID 40947861›Full record

Trial reportCancer prevention research (Philadelphia, Pa.)2025

The Effect of Butyrylated Starch on Bowel Polyps in Familial Adenomatous Polyposis: Results of a Randomized, Double-blind, Placebo-Controlled Crossover Trial.

Julie M Clarke, Trevor J Lockett, Karen L Harrap, Brooke E Flanders, Virginia Bird, Alex Boussioutas, Mark Appleyard, David Williams, Sophie Zaloumis, Arun Gupta and 7 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Cancer prevention research (Philadelphia, Pa.), 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Review
  2. 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

17 authors.

Julie M ClarkeProject Leader, CSIRO Health and Biosecurity Adelaide, North Adelaide, Australia.ORCID 0000-0003-4676-0366
Trevor J LockettGroup Leader, CSIRO Health and Biosecurity, North Ryde, Australia.ORCID 0000-0002-8063-071X
Karen L HarrapSenior Engineer, CSIRO Health and Biosecurity, Herston, Australia.ORCID 0000-0002-6792-2910
Brooke E FlandersNational Study Co-ordinator, Department of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Victoria, Australia.ORCID 0009-0003-3985-8805
Virginia BirdStudy Coordinator, Department of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Victoria, Australia.ORCID 0009-0000-7506-2570
Alex BoussioutasProfessor Director of Clinical Genetics and Genomics, Alfred and Monash University, Victoria, Australia.ORCID 0000-0002-8109-6897
Mark AppleyardDirector of Gastroenterology and Hepatology, Royal Brisbane & Women's Hospital, Herston, Australia.ORCID 0000-0003-2714-8657
David WilliamsHead of Department of Gastroenterology and Hepatology, St Vincent's Hospital, Sydney, Australia.ORCID 0000-0002-0808-0311
Sophie ZaloumisSenior Research Fellow, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.ORCID 0000-0002-8253-8896
Arun GuptaHonorary Research Fellow, Department of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.ORCID 0000-0002-8742-2163
Suresh SivanesanConsultant Gastroenterologist, Department of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.ORCID 0009-0006-1595-6701
Aysha Al-AniIBD Fellow, Department of Gastroenterology, Royal Melbourne Hospital, Melbourne, Australia.ORCID 0000-0002-4735-5234
Ralley PrenticeGastroenterology Registrar, Department of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Melbourne, Australia.ORCID 0000-0002-4331-9295
Allan D SpigelmanFaculty of Medicine, University of New South Wales, Sydney, Australia.ORCID 0000-0002-7409-1684
Digsu N KoyeResearch Fellow, Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Australia.ORCID 0000-0002-8442-3048
Patrick M LynchProfessor of Gastroenterology, Hepatology and Nutrition, Division of Internal Medicine, MD Anderson Cancer Center, Houston, Texas.ORCID 0000-0003-0125-3109
Finlay A MacraeHead of Colorectal Medicine and Genetics, Royal Melbourne Hospital, Victoria, Australia.ORCID 0000-0003-4035-9678

Funding

Cancer Council NSW (Cancer Council New South Wales) APP1031108Cancer Council Queensland (CCQ) APP1031108Cancer Council South Australia (Cancer Council SA) APP1031108Cancer Council Victoria APP1031108
6 · The paper itself

Abstract

Butyrate may reduce the risk of colorectal cancer and can be delivered to the colon using butyrylated high-amylose maize starch (HAMSB). This trial evaluated the effects of HAMSB on polyp burden in participants with familial adenomatous polyposis. This study was a randomized, double-blind, placebo-controlled crossover trial. In three 6-month periods, participants ingested 40 g/day of HAMSB or low-amylose starch, followed by the alternative, and then a washout. Participants underwent four video-recorded colonoscopies to assess polyp burden as the primary endpoint. At baseline, two distal bowel tattoos were placed: tattoo one where polyps were cleared at each scope and tattoo two where polyps were left in situ. Generalized linear mixed models were used to estimate the ratio of mean polyp counts in intervention compared with placebo periods. Seventy-two participants were randomized (33 female), with 49 completing the study. In the intention-to-treat analysis, HAMSB did not reduce mean global [0.9 fold change (FC); 95% confidence interval (CI), 0.77-1.06; P = 0.218] or small (<2.4 mm) polyp numbers (0.88 FC; 95% CI, 0.71-1.1; P = 0.267). There was a trend for the reduction of small polyps in tattoo one (0.72 FC; 95% CI, 0.5-1.03; P = 0.074). In the per-protocol analysis, there was a strong trend for HAMSB to reduce mean global small polyp numbers (0.79 FC; 95% CI, 0.62-1; P = 0.051). HAMSB may reduce polyp initiation in the distal bowel without causing regression or growth of existing polyps. However, 95% CIs indicate large uncertainty to the true direction of the treatment effect, and the P values provide only weak evidence against the null hypothesis of no treatment effect. PREVENTION RELEVANCE: There is convincing evidence that dietary fiber reduces the risk of colorectal cancer possibly by production of butyrate during microbial fermentation of indigestible fiber. This study was designed to determine if a dietary supplement that delivers butyrate to the colon reduces polyp burden in participants with familial adenomatous polyposis.

Indexed as

Adenomatous Polyposis ColiIntestinal PolypsStarchAdultAmyloseColonoscopyCross-Over StudiesDouble-Blind MethodFemaleFollow-Up StudiesHumansMaleMiddle AgedAmyloseStarch

Identifiers

PMID40947861
PMCPMC12580826

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.