Prostate Cancer (Adenocarcinoma)EVENTIDENCT06661044
Understanding the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer
An observational study of Prostate Cancer (Adenocarcinoma), run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
The digestive tract (large intestine) contains microorganisms that digest complex carbohydrates in food to produce chemical substances which are beneficial to human health. The population of these microorganisms in faeces (stool samples) could be used to diagnose the health status of a person and this can be changed… Read more about this study
- Who is it for?
- Ages 60 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer (Adenocarcinoma)
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Nov 2024to 31 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The investigators will also invite men over 60 years who are staff at the University of Aberdeen, via All Staff mailing lists (including SMMSN and Rowett) and the University's weekly News Update and small ads.
Who may be able to join
- Men (biologically male) over 60 years old.
- Regularly pass a bowel motion at least daily.
- Able to attend the Rowett Institute for consent procedure and able to arrange delivery of fresh faecal sample to the Rowett Institute on the required study day.
Who cannot join
- Living with cancer/on active cancer treatment.
- Active ulcerative colitis or Crohn's disease.
- Antibiotic therapy within previous 3 months.
- Diarrhoea from recent foreign travel.
- Known HIV or Hepatitis B positive.
- Working directly on specific study for which samples are required.
- Line managed or supervised by PI of study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Aberdeen
Aberdeen, Scotland, AB25 2ZD
About this study
Official title: Exploiting Human Microbiota-associated in Vivo Models for Mechanistic Studies to Understand the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer
The digestive tract (large intestine) contains microorganisms that digest complex carbohydrates in food to produce chemical substances which are beneficial to human health. The population of these microorganisms in faeces (stool samples) could be used to diagnose the health status of a person and this can be changed with the use of antibiotics, diet, radiotherapy or infection.
Dietary fibre supplements can help provide nutrients for the beneficial bacteria from the large intestine to produce useful chemicals that may delay growth or even shrink prostate cancer in patients.
Read more
The investigators will feed mice diets containing several dietary fibres (including inulin, pectin and hemp hull) and also faeces from healthy male human volunteers over 60 years old to see what effect this has on the makeup of the bacteria in their gut and the resulting beneficial metabolites (chemicals). For this work, the research team need to obtain four to six fresh faecal samples on the same day, so that these can be mixed fresh and stored for use as faecal microbiota transplant (FMT) in the mice.
The researchers will then test how altering the gut microorganisms with faeces and dietary fibre supplements can influence the growth of prostate cancer cell tumours in mice. The investigators expect to see an effect of the fibres in promoting beneficial bacteria and in shrinking the tumours.
This work will allow the investigators to identify dietary fibres that could be used in nutritional therapies for management of prostate cancer patients in future.
Read the detailed description
Prostate cancer is the commonest cancer in men and the fifth most common cause of cancer-related deaths globally. Increased prostate-specific antigen (PSA) screening and longer life expectancies in men have resulted in a substantial increase in the incidence and prevalence of prostate cancer in older men. Between 2021 and 2022, over 50,000 newly diagnosed cases of prostate cancer were reported in the UK, representing a 27% increase in incidence compared to 2019 and causing over 16,000 deaths.
Prostate cancer in its initial stages maybe asymptomatic and progresses slowly, meaning that some men do not need immediate active treatment but can be monitored on 'active surveillance'. Active surveillance was developed as an approach to addressing overtreatment; by delaying or preventing unnecessary definitive treatment, typically surgical removal of the prostate (radical prostatectomy, RP) or radical radiotherapy to the prostate (RT), and their related complications. It involves routine monitoring of PSA levels, medical imaging, digital rectal exams, and prostate biopsies and is recommended for prostate cancer patients with a low risk of developing aggressive tumours.
The process of active surveillance can be quite stressful for some patients and many of these patients are eager to do everything they can to slow the progression of their disease, including making lifestyle changes such as changing their diet and doing physical exercise.
Diet influences the diversity of the microbiota (archaea, bacteria, fungi and viruses) in the gastrointestinal tract. The gut microbiota play crucial functions in metabolic and regulatory processes that impact the body's immunity and disease development. One can increase the consumption of dietary fibre by providing supplements in powder or capsule form, where the dose administered can be controlled. When these dietary fibres are eaten, commensal colonic bacteria ferment them to produce metabolites, including short-chain fatty acids (SCFAs) which can have anti-tumour effects.
This study team and other researchers have reported the effect of the soluble dietary fibre inulin in delaying tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including bladder and colorectal cancers). Pectin has also been reported to have health benefits such as maintaining the intestinal barrier, improving physical bowel function and reducing glucose and cholesterol absorption. Apple pectin has also been shown to induce apoptosis in colorectal cancer cells.
UK fibre intake at a population level is well below the recommended levels of 30 g per day, with only 9% of adults meeting recommended intakes.
According to a US population-based study, higher fibre intake was inversely associated with prostate cancer aggressiveness and in an intervention study with modified citrus pectin, 78% of men with non-metastatic prostate cancer who had biochemically relapsed responded to therapy: 58% showed decreased PSA and 75% showed improvement in PSA doubling time (p=0.003).
Inulin and pectin are purified soluble fibres from chicory root, citrus, apple and other plants; in contrast, hemp hull is a rich source of whole fibre which also contains bioactive chemicals including flavonoids, proanthocyanidins and phenolic acids. It has been previously reported to have biological activities such as immune-modulating, anti-inflammatory and antineoplastic properties in different cancer cells. Furthermore, hemp hull is a rich source of phytic acid which releases myo-inositol in the human intestine by the activity of microbial phytases. Myoinositol supplementation significantly decreased triglycerides; men with elevated triglycerides might be at increased risk of developing prostate cancer or recurrence following surgery. Therefore, the consumption of whole fibres would bring additional benefits in the prevention of prostate cancer. Preliminary animal studies demonstrated that dietary phytic acid increased the production of microbial short-chain fatty acids (SCFA), including propionate and butyrate, with changes in microbial composition.
Hemp hull is a sustainable fibre source, from a carbon-neutral crop promoting agricultural biodiversity which can help meet dietary fibre intake recommendations. Hemp hulls (obtained after seed decortication) contain 74% fibre which can be milled into hemp hull flour.
Another method to improve tumour control by modifying the gut microbiota, which could be combined with dietary fibre supplementation, is via faecal microbiota transplantation (FMT). This method involves transferring faecal bacteria and other microorganisms from a healthy individual into another person to directly alter the recipient's microbial composition and provide a health benefit. There is increasing interest in the use of FMT for gastrointestinal infections and inflammatory diseases, as well as extraintestinal conditions including autoimmune and metabolic disorders such as cancer, diabetes and non-alcoholic fatty liver disease. In another study, FMT was administered with cancer immunotherapy drugs (nivolumab or pembrolizumab) to mice and enhanced the activity of these drugs in controlling the growth of MCA-205 sarcoma tumours. Also, in a phase I trial, 65% of all patients who received a faecal transplant successfully acquired similarity to the donor microbiomes and experienced an enrichment of immunogenic bacteria and a loss of deleterious bacteria following FMT.
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Prostate cancer, Dietary fibre, Faecal microbiota transplant, Radiotherapy
- Medical subject headings
- Prostatic Neoplasms, Adenocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
16S rRNA gene sequencing
The investigators will extract bacterial DNA for 16S rRNA gene sequencing analysis to compare the baseline microbial community of volunteers to that of the mice microbiota after faecal microbiota transplantation.
Measured: December 2024 to October 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2024
- Study start15 Nov 2024
- Primary completion31 Dec 2024
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for Prostate Cancer (Adenocarcinoma)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- NHS Grampian
- Responsible party
- Sponsor
- Investigators
- Anne E Kiltie, MA, DN, DSc, Principal investigator, University of Aberdeen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06661044
- Sponsor's protocol ID
- 2-054-24
- Other IDs
- 556
- Acronym
- EVENTIDE
- Status last verified
- Dec 2024
- First submitted
- 24 Oct 2024
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not appropriate
Publications
Routy B, Lenehan JG, Miller WH Jr, Jamal R, Messaoudene M, Daisley BA, Hes C, Al KF, Martinez-Gili L, Puncochar M, Ernst S, Logan D, Belanger K, Esfahani K, Richard C, Ninkov M, Piccinno G, Armanini F, Pinto F, Krishnamoorthy M, Figueredo R, Thebault P, Takis P, Magrill J, Ramsay L, Derosa L, Marchesi JR, Parvathy SN, Elkrief A, Watson IR, Lapointe R, Segata N, Haeryfar SMM, Mullish BH, Silverman MS, Burton JP, Maleki Vareki S. Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial. Nat Med. 2023 Aug;29(8):2121-2132. doi: 10.1038/s41591-023-02453-x. Epub 2023 Jul 6.
PubMed 37414899Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
PubMed 24018052Bui TPN, Manneras-Holm L, Puschmann R, Wu H, Troise AD, Nijsse B, Boeren S, Backhed F, Fiedler D, deVos WM. Conversion of dietary inositol into propionate and acetate by commensal Anaerostipes associates with host health. Nat Commun. 2021 Aug 10;12(1):4798. doi: 10.1038/s41467-021-25081-w.
PubMed 34376656Allott EH, Howard LE, Cooperberg MR, Kane CJ, Aronson WJ, Terris MK, Amling CL, Freedland SJ. Serum lipid profile and risk of prostate cancer recurrence: Results from the SEARCH database. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2349-56. doi: 10.1158/1055-9965.EPI-14-0458. Epub 2014 Oct 10.
PubMed 25304929Zhu S, Hu X, Fan Y. Association of triglyceride levels and prostate cancer: a Mendelian randomization study. BMC Urol. 2022 Oct 31;22(1):167. doi: 10.1186/s12894-022-01120-6.
PubMed 36316671Tabrizi R, Ostadmohammadi V, Lankarani KB, Peymani P, Akbari M, Kolahdooz F, Asemi Z. The effects of inositol supplementation on lipid profiles among patients with metabolic diseases: a systematic review and meta-analysis of randomized controlled trials. Lipids Health Dis. 2018 May 24;17(1):123. doi: 10.1186/s12944-018-0779-4.
PubMed 29793496Ligresti A, Moriello AS, Starowicz K, Matias I, Pisanti S, De Petrocellis L, Laezza C, Portella G, Bifulco M, Di Marzo V. Antitumor activity of plant cannabinoids with emphasis on the effect of cannabidiol on human breast carcinoma. J Pharmacol Exp Ther. 2006 Sep;318(3):1375-87. doi: 10.1124/jpet.106.105247. Epub 2006 May 25.
PubMed 16728591Keizman D, Frenkel M, Peer A, Kushnir I, Rosenbaum E, Sarid D, Leibovitch I, Mano R, Yossepowitch O, Margel D, Wolf I, Geva R, Dresler H, Rouvinov K, Rapoport N, Eliaz I. Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Results of a Prospective Phase II Study. Nutrients. 2021 Nov 28;13(12):4295. doi: 10.3390/nu13124295.
PubMed 34959847Tabung F, Steck SE, Su LJ, Mohler JL, Fontham ET, Bensen JT, Hebert JR, Zhang H, Arab L. Intake of grains and dietary fiber and prostate cancer aggressiveness by race. Prostate Cancer. 2012;2012:323296. doi: 10.1155/2012/323296. Epub 2012 Nov 13.
PubMed 23213538Blanco-Perez F, Steigerwald H, Schulke S, Vieths S, Toda M, Scheurer S. The Dietary Fiber Pectin: Health Benefits and Potential for the Treatment of Allergies by Modulation of Gut Microbiota. Curr Allergy Asthma Rep. 2021 Sep 10;21(10):43. doi: 10.1007/s11882-021-01020-z.
PubMed 34505973Ewaschuk JB, Dieleman LA. Probiotics and prebiotics in chronic inflammatory bowel diseases. World J Gastroenterol. 2006 Oct 7;12(37):5941-50. doi: 10.3748/wjg.v12.i37.5941.
PubMed 17009391Li Y, Elmen L, Segota I, Xian Y, Tinoco R, Feng Y, Fujita Y, Segura Munoz RR, Schmaltz R, Bradley LM, Ramer-Tait A, Zarecki R, Long T, Peterson SN, Ronai ZA. Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. Cell Rep. 2020 Feb 11;30(6):1753-1766.e6. doi: 10.1016/j.celrep.2020.01.035.
PubMed 32049008Then CK, Paillas S, Wang X, Hampson A, Kiltie AE. Association of Bacteroides acidifaciens relative abundance with high-fibre diet-associated radiosensitisation. BMC Biol. 2020 Aug 19;18(1):102. doi: 10.1186/s12915-020-00836-x.
PubMed 32811478de Vos II, Luiting HB, Roobol MJ. Active Surveillance for Prostate Cancer: Past, Current, and Future Trends. J Pers Med. 2023 Apr 3;13(4):629. doi: 10.3390/jpm13040629.
PubMed 37109015Siegel DA, O'Neil ME, Richards TB, Dowling NF, Weir HK. Prostate Cancer Incidence and Survival, by Stage and Race/Ethnicity - United States, 2001-2017. MMWR Morb Mortal Wkly Rep. 2020 Oct 16;69(41):1473-1480. doi: 10.15585/mmwr.mm6941a1.
PubMed 33056955
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploiting Human Microbiota-associated in Vivo Models for Mechanistic Studies to Understand the Benefits of Dietary Fibre Supplementation in Patients With Prostate Cancer
- ClinicalTrials.gov ID
- NCT06661044
- Acronym / sponsor ID
- EVENTIDE / 2-054-24
- Conditions
- Prostate Cancer (Adenocarcinoma)
- Keywords
- Prostate cancer, Dietary fibre, Faecal microbiota transplant, Radiotherapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- NHS Grampian
- Study start
- 15 Nov 2024 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 28 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The digestive tract (large intestine) contains microorganisms that digest complex carbohydrates in food to produce chemical substances which are beneficial to human health. The population of these microorganisms in faeces (stool samples) could be used to diagnose the health status of a person and this can be changed with the use of antibiotics, diet, radiotherapy or infection.
Dietary fibre supplements can help provide nutrients for the beneficial bacteria from the large intestine to produce useful chemicals that may delay growth or even shrink prostate cancer in patients.
The investigators will feed mice diets containing several dietary fibres (including inulin, pectin and hemp hull) and also faeces from healthy male human volunteers over 60 years old to see what effect this has on the makeup of the bacteria in their gut and the resulting beneficial metabolites (chemicals). For this work, the research team need to obtain four to six fresh faecal samples on the same day, so that these can be mixed fresh and stored for use as faecal microbiota transplant (FMT) in the mice.
The researchers will then test how altering the gut microorganisms with faeces and dietary fibre supplements can influence the growth of prostate cancer cell tumours in mice. The investigators expect to see an effect of the fibres in promoting beneficial bacteria and in shrinking the tumours.
This work will allow the investigators to identify dietary fibres that could be used in nutritional therapies for management of prostate cancer patients in future.
Detailed description
Prostate cancer is the commonest cancer in men and the fifth most common cause of cancer-related deaths globally. Increased prostate-specific antigen (PSA) screening and longer life expectancies in men have resulted in a substantial increase in the incidence and prevalence of prostate cancer in older men. Between 2021 and 2022, over 50,000 newly diagnosed cases of prostate cancer were reported in the UK, representing a 27% increase in incidence compared to 2019 and causing over 16,000 deaths.
Prostate cancer in its initial stages maybe asymptomatic and progresses slowly, meaning that some men do not need immediate active treatment but can be monitored on 'active surveillance'. Active surveillance was developed as an approach to addressing overtreatment; by delaying or preventing unnecessary definitive treatment, typically surgical removal of the prostate (radical prostatectomy, RP) or radical radiotherapy to the prostate (RT), and their related complications. It involves routine monitoring of PSA levels, medical imaging, digital rectal exams, and prostate biopsies and is recommended for prostate cancer patients with a low risk of developing aggressive tumours.
The process of active surveillance can be quite stressful for some patients and many of these patients are eager to do everything they can to slow the progression of their disease, including making lifestyle changes such as changing their diet and doing physical exercise.
Diet influences the diversity of the microbiota (archaea, bacteria, fungi and viruses) in the gastrointestinal tract. The gut microbiota play crucial functions in metabolic and regulatory processes that impact the body's immunity and disease development. One can increase the consumption of dietary fibre by providing supplements in powder or capsule form, where the dose administered can be controlled. When these dietary fibres are eaten, commensal colonic bacteria ferment them to produce metabolites, including short-chain fatty acids (SCFAs) which can have anti-tumour effects.
This study team and other researchers have reported the effect of the soluble dietary fibre inulin in delaying tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including bladder and colorectal cancers). Pectin has also been reported to have health benefits such as maintaining the intestinal barrier, improving physical bowel function and reducing glucose and cholesterol absorption. Apple pectin has also been shown to induce apoptosis in colorectal cancer cells.
UK fibre intake at a population level is well below the recommended levels of 30 g per day, with only 9% of adults meeting recommended intakes.
According to a US population-based study, higher fibre intake was inversely associated with prostate cancer aggressiveness and in an intervention study with modified citrus pectin, 78% of men with non-metastatic prostate cancer who had biochemically relapsed responded to therapy: 58% showed decreased PSA and 75% showed improvement in PSA doubling time (p=0.003).
Inulin and pectin are purified soluble fibres from chicory root, citrus, apple and other plants; in contrast, hemp hull is a rich source of whole fibre which also contains bioactive chemicals including flavonoids, proanthocyanidins and phenolic acids. It has been previously reported to have biological activities such as immune-modulating, anti-inflammatory and antineoplastic properties in different cancer cells. Furthermore, hemp hull is a rich source of phytic acid which releases myo-inositol in the human intestine by the activity of microbial phytases. Myoinositol supplementation significantly decreased triglycerides; men with elevated triglycerides might be at increased risk of developing prostate cancer or recurrence following surgery. Therefore, the consumption of whole fibres would bring additional benefits in the prevention of prostate cancer. Preliminary animal studies demonstrated that dietary phytic acid increased the production of microbial short-chain fatty acids (SCFA), including propionate and butyrate, with changes in microbial composition.
Hemp hull is a sustainable fibre source, from a carbon-neutral crop promoting agricultural biodiversity which can help meet dietary fibre intake recommendations. Hemp hulls (obtained after seed decortication) contain 74% fibre which can be milled into hemp hull flour.
Another method to improve tumour control by modifying the gut microbiota, which could be combined with dietary fibre supplementation, is via faecal microbiota transplantation (FMT). This method involves transferring faecal bacteria and other microorganisms from a healthy individual into another person to directly alter the recipient's microbial composition and provide a health benefit. There is increasing interest in the use of FMT for gastrointestinal infections and inflammatory diseases, as well as extraintestinal conditions including autoimmune and metabolic disorders such as cancer, diabetes and non-alcoholic fatty liver disease. In another study, FMT was administered with cancer immunotherapy drugs (nivolumab or pembrolizumab) to mice and enhanced the activity of these drugs in controlling the growth of MCA-205 sarcoma tumours. Also, in a phase I trial, 65% of all patients who received a faecal transplant successfully acquired similarity to the donor microbiomes and experienced an enrichment of immunogenic bacteria and a loss of deleterious bacteria following FMT.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The investigators will also invite men over 60 years who are staff at the University of Aberdeen, via All Staff mailing lists (including SMMSN and Rowett) and the University's weekly News Update and small ads.
Key inclusion criteria (3 listed)
- Men (biologically male) over 60 years old.
- Regularly pass a bowel motion at least daily.
- Able to attend the Rowett Institute for consent procedure and able to arrange delivery of fresh faecal sample to the Rowett Institute on the required study day.
Key exclusion criteria (7 listed)
- Living with cancer/on active cancer treatment.
- Active ulcerative colitis or Crohn's disease.
- Antibiotic therapy within previous 3 months.
- Diarrhoea from recent foreign travel.
- Known HIV or Hepatitis B positive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
16S rRNA gene sequencing
Time frame: December 2024 to October 2025
The investigators will extract bacterial DNA for 16S rRNA gene sequencing analysis to compare the baseline microbial community of volunteers to that of the mice microbiota after faecal microbiota transplantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Results publication: PubMed 37414899Routy B, Lenehan JG, Miller WH Jr, Jamal R, Messaoudene M, Daisley BA, Hes C, Al KF, Martinez-Gili L, Puncochar M, Ernst S, Logan D, Belanger K, Esfahani K, Richard C, Ninkov M, Piccinno G, Armanini F, Pinto F, Krishnamoorthy M, Figueredo R, Thebault P, Takis P, Magrill J, Ramsay L, Derosa L, Marchesi JR, Parvathy SN, Elkrief A, Watson IR, Lapointe R, Segata N, Haeryfar SMM, Mullish BH, Silverman MS, Burton JP, Maleki Vareki S. Fecal microbiota transplantation plus anti-PD-1 immunotherapy in advanced melanoma: a phase I trial. Nat Med. 2023 Aug;29(8):2121-2132. doi: 10.1038/s41591-023-02453-x. Epub 2023 Jul 6.
- Results publication: PubMed 24018052Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
- Results publication: PubMed 34376656Bui TPN, Manneras-Holm L, Puschmann R, Wu H, Troise AD, Nijsse B, Boeren S, Backhed F, Fiedler D, deVos WM. Conversion of dietary inositol into propionate and acetate by commensal Anaerostipes associates with host health. Nat Commun. 2021 Aug 10;12(1):4798. doi: 10.1038/s41467-021-25081-w.
- Results publication: PubMed 25304929Allott EH, Howard LE, Cooperberg MR, Kane CJ, Aronson WJ, Terris MK, Amling CL, Freedland SJ. Serum lipid profile and risk of prostate cancer recurrence: Results from the SEARCH database. Cancer Epidemiol Biomarkers Prev. 2014 Nov;23(11):2349-56. doi: 10.1158/1055-9965.EPI-14-0458. Epub 2014 Oct 10.
- Results publication: PubMed 36316671Zhu S, Hu X, Fan Y. Association of triglyceride levels and prostate cancer: a Mendelian randomization study. BMC Urol. 2022 Oct 31;22(1):167. doi: 10.1186/s12894-022-01120-6.
- Results publication: PubMed 29793496Tabrizi R, Ostadmohammadi V, Lankarani KB, Peymani P, Akbari M, Kolahdooz F, Asemi Z. The effects of inositol supplementation on lipid profiles among patients with metabolic diseases: a systematic review and meta-analysis of randomized controlled trials. Lipids Health Dis. 2018 May 24;17(1):123. doi: 10.1186/s12944-018-0779-4.
- Results publication: PubMed 16728591Ligresti A, Moriello AS, Starowicz K, Matias I, Pisanti S, De Petrocellis L, Laezza C, Portella G, Bifulco M, Di Marzo V. Antitumor activity of plant cannabinoids with emphasis on the effect of cannabidiol on human breast carcinoma. J Pharmacol Exp Ther. 2006 Sep;318(3):1375-87. doi: 10.1124/jpet.106.105247. Epub 2006 May 25.
- Results publication: PubMed 34959847Keizman D, Frenkel M, Peer A, Kushnir I, Rosenbaum E, Sarid D, Leibovitch I, Mano R, Yossepowitch O, Margel D, Wolf I, Geva R, Dresler H, Rouvinov K, Rapoport N, Eliaz I. Modified Citrus Pectin Treatment in Non-Metastatic Biochemically Relapsed Prostate Cancer: Results of a Prospective Phase II Study. Nutrients. 2021 Nov 28;13(12):4295. doi: 10.3390/nu13124295.
- Results publication: PubMed 23213538Tabung F, Steck SE, Su LJ, Mohler JL, Fontham ET, Bensen JT, Hebert JR, Zhang H, Arab L. Intake of grains and dietary fiber and prostate cancer aggressiveness by race. Prostate Cancer. 2012;2012:323296. doi: 10.1155/2012/323296. Epub 2012 Nov 13.
- Results publication: PubMed 34505973Blanco-Perez F, Steigerwald H, Schulke S, Vieths S, Toda M, Scheurer S. The Dietary Fiber Pectin: Health Benefits and Potential for the Treatment of Allergies by Modulation of Gut Microbiota. Curr Allergy Asthma Rep. 2021 Sep 10;21(10):43. doi: 10.1007/s11882-021-01020-z.
- Results publication: PubMed 17009391Ewaschuk JB, Dieleman LA. Probiotics and prebiotics in chronic inflammatory bowel diseases. World J Gastroenterol. 2006 Oct 7;12(37):5941-50. doi: 10.3748/wjg.v12.i37.5941.
- Results publication: PubMed 32049008Li Y, Elmen L, Segota I, Xian Y, Tinoco R, Feng Y, Fujita Y, Segura Munoz RR, Schmaltz R, Bradley LM, Ramer-Tait A, Zarecki R, Long T, Peterson SN, Ronai ZA. Prebiotic-Induced Anti-tumor Immunity Attenuates Tumor Growth. Cell Rep. 2020 Feb 11;30(6):1753-1766.e6. doi: 10.1016/j.celrep.2020.01.035.
- NDNS: results from years 9 to 11 (2016 to 2017 and 2018 to 2019)Link provided by the sponsor.
- National Prostate Cancer Audit (NPCA), NPCA State of the Nation ReportLink provided by the sponsor.
- Individual participant dataSharing planned: No. Not appropriate
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne E Kiltie, MA, DN, DSc principal investigator
University of Aberdeen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer (Adenocarcinoma), run by University of Aberdeen at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
16S rRNA gene sequencing (time frame: December 2024 to October 2025). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06661044, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.