Prostate CancerDEFINITENCT07790003
Dietary Fibre Supplementation to Delay Disease Progression in Early Prostate Cancer
An observational study of Prostate Cancer and Prostatic Neoplasm, run by University of Aberdeen at 1 site in United Kingdom.
Trial summary
This qualitative research study, based on semi-structured interviews and a focus group, aims to explore the attitudes of prostate cancer patients on active surveillance (AS) towards dietary fibre supplementation, given the potential benefits demonstrated in previous research. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer, Prostatic Neoplasm, Dietary Fibre Modification
- What is being tested?
- Qualitative semi-structured interviews and Focus group
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Jul 2024to 22 Oct 2024
- 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 18 years and older
- Men only
- Adult, Older adult
Study population: Men on active surveillance for prostate cancer from North-East Scotland.
Who may be able to join
- Participants over 18 years of age.
- Participants with residence in North-East Scotland.
- Participants must be fluent in the English language.
- Participants on active surveillance.
Who cannot join
- Participants who do not speak fluent English will be excluded from this study.
- Participants who were treated with surgery, radiotherapy, chemotherapy or anti-androgen therapy for their prostate cancer.
- Vulnerable participants, classified as adults who do not have the capacity to consent for themselves, will not be included in the study. If the research team are made aware that someone has lost capacity then they will be withdrawn from the study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, Aberdeen City, AB25 2ZD
About this study
This qualitative research study, based on semi-structured interviews and a focus group, aims to explore the attitudes of prostate cancer patients on active surveillance (AS) towards dietary fibre supplementation, given the potential benefits demonstrated in previous research. Prostate cancer patients on AS, often overlooked in the literature, experience cyclical anxiety, particularly regarding disease progression. Lifestyle modifications, including dietary changes, are pursued by a number of these patients as a preventative measure. Dietary fibre such as inulin and psyllium have promising results in studies of pelvic cancers. However, it is important to note that these findings do not directly apply to patients who are currently undergoing AS for prostate cancer. Despite potential side effects, these dietary fibres may contribute to anti-inflammatory and antitumorigenic effects.
Building on this evidence, the investigators aim to explore patient perspectives on the feasibility and acceptability of dietary fibre supplementation during AS. The insights gained will guide the development of a feasibility and/or pilot studies and, subsequently, a multicentre randomised controlled trial. If successful, this intervention could potentially reshape clinical practice for patients with prostate cancer on AS.
Read the detailed description
Active surveillance (AS) is commonly recommended for men diagnosed with localised prostate cancer who have a low risk of tumour spread. If the prostate cancer progresses to a more aggressive form, this will require active treatment - typically surgical removal of the prostate (radical prostatectomy) or radical radiotherapy to the prostate.
At Aberdeen Royal Infirmary (ARI) Urological unit, the AS protocol involves repeat MRI scans and biopsies being performed at the end of year 1, followed by subsequent radiological and histological investigations every two years, accompanied by either 3- or 6-monthly routine monitoring of specific biochemical (i.e. prostate-specific antigen) levels. In other words, AS is a clinical pathway that aims to monitor early prostate cancer, rather than treating it straight away.
Men undergoing AS, an often-overlooked group in the literature, experience certain levels of cyclical anxiety. This cohort may experience persistent apprehension regarding disease progression, with the fear lingering in the background of their thoughts. Anxiety intensifies around routine appointments with the AS protocol, and new concerns may emerge, particularly relating to fluctuations in their PSA levels. In a recent descriptive analysis, it was found that out of the 43.6% of men who discontinued AS after five years, roughly 12.8% of dropouts occurred because they converted to active treatment without any evidence of disease progression. Therefore, a considerable number of patients exhibit a strong inclination to actively engage in lifestyle modifications in an effort to attempt the prevention of disease progression. This approach includes an interest in modifying their dietary habits.
Dietary fibre, such as psyllium and inulin, are non-digestible carbohydrates that are found in fruits, vegetables, whole grains and legumes. The gut microbiota anaerobically ferments dietary fibre, producing short-chain fatty acids (SCFAs), including acetate, propionate and butyrate. SCFAs play a pivotal role in the intricate relationship between food, gut microbiota and health, exhibiting notable anti-inflammatory and anti-tumorigenic properties.
In a population-based case-only study conducted in the USA, higher fibre intake was inversely associated with prostate cancer aggressiveness (odds ratios 0.70, 95% confidence interval 0.50-0.97 and 0.61 95% CI 0.40-0.93, for 2nd and 3rd tertiles of total fibre intake, respectively). Additionally, a prospective phase II dietary intervention study, using the fibre supplement modified citrus pectin in men with non-metastatic prostate cancer who had biochemically relapsed, showed promising results. 78% of men responded to the therapy, with 58% having a decreased or stable PSA and 75% an improvement in PSA doubling time (PSADT), and median PSADT was significantly improved (p=0.003).
The Kiltie Lab and others have demonstrated the benefit of the rapidly fermented, soluble dietary fibre inulin in controlling tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including prostate, colorectal cancer and bladder cancer). However, this can come at the expense of side effects in humans including flatulence and bloatedness. Psyllium is another fibre which is commonly used to treat constipation but it is also widely used to treat the diarrhoea caused by radiotherapy to the prostate region. Recently, the addition of psyllium was found to significantly reduce gas production in the colon from the fermentation of inulin, in human subjects with irritable bowel syndrome.
Given this body of evidence, the investigators would like to explore and evaluate the attitudes of patients regarding the potential of dietary fibre supplementation during AS. It is hoped that this qualitative research will provide valuable insights that will support and inform the development of a pilot and feasibility studies on dietary fibre supplementation for prostate cancer patients on AS, delaying the time to active treatment or obviating its use. Subsequently, the intention is to establish a UK multicentre, randomised controlled trial. This may subsequently change clinical practice for patients with prostate cancer on AS.
- Being tested
- Qualitative semi-structured interviews, Focus group
- Keywords
- Active Surveillance, Dietary Fibre Modification, Prostate Cancer
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative semi-structured interviewsOther
The research fellow will conduct a total of 12 semi-structured individual interviews, either via video (MS Teams) or telephone format, based on participant preference. The investigators will employ a semi-structured interview methodology as it collects richer data and allows for in-depth exploration of the participant's insights. Interviews will be conducted at a time convenient to the participant. The topic guide will structure the interview format. Each participant will be interviewed only once.
Focus groupOther
Subsequently, the investigators will hold one focus group online via video (MS Teams) with six participants, which will be run by the research fellow and one of the academic supervisors. The topic guide will structure the interview format.
| Study group | Role | What they receive |
|---|---|---|
| Patients with prostate cancer on active surveillance. | Qualitative semi-structured interviews and a focus group with patients who have prostate cancer and are currently on active surveillance.
Intervention: Other: Qualitative interviews and focus group. Receives: Other: Qualitative semi-structured interviews; Other: Focus group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attitudes and preferences of men on active surveillance for prostate cancer regarding dietary supplementation.
Semi-structured interviews will explore men's views on incorporating dietary fibre supplementation (inulin with or without psyllium), into active surveillance for prostate cancer. Responses will be analysed thematically using the Theoretical Framework of Acceptability.
Measured: At a single interview following enrolment (approximately 30-45 minutes)
Secondary outcomes (1)
Barriers/facilitators to dietary fibre adherence during active surveillance
Same semi-structured interviews will explore the practical and personal factors that may make it easier or more difficult for men to regularly take dietary fibre supplements during active surveillance. Responses will be analysed thematically using the Theoretical Framework of Acceptability.supplementation among men on active surveillance, including any physical, emotional or psychological effects.
Measured: At a single interview following enrolment (approximately 30-45 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2026
- Study start3 Jul 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Prostate CancerStudies 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
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aberdeen
- Sponsor type
- University, hospital or other
- Collaborators
- Friends of ANCHOR
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07790003
- Sponsor's protocol ID
- 1234567890
- Acronym
- DEFINITE
- Status last verified
- May 2026
- First submitted
- 11 Mar 2024
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Van Hemelrijck M, Ji X, Helleman J, Roobol MJ, van der Linden W, Nieboer D, Bangma CH, Frydenberg M, Rannikko A, Lee LS, Gnanapragasam VJ, Kattan MW; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium. Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium. Eur Urol. 2019 Mar;75(3):523-531. doi: 10.1016/j.eururo.2018.10.025. Epub 2018 Oct 29.
PubMed 30385049Daubenmier JJ, Weidner G, Marlin R, Crutchfield L, Dunn-Emke S, Chi C, Gao B, Carroll P, Ornish D. Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance. Urology. 2006 Jan;67(1):125-30. doi: 10.1016/j.urology.2005.07.056.
PubMed 16413347Dovey Z, Horowitz A, Waingankar N. The influence of lifestyle changes (diet, exercise and stress reduction) on prostate cancer tumour biology and patient outcomes: A systematic review. BJUI Compass. 2023 Apr 6;4(4):385-416. doi: 10.1002/bco2.237. eCollection 2023 Jul.
PubMed 37334023Bishehsari F, Engen PA, Preite NZ, Tuncil YE, Naqib A, Shaikh M, Rossi M, Wilber S, Green SJ, Hamaker BR, Khazaie K, Voigt RM, Forsyth CB, Keshavarzian A. Dietary Fiber Treatment Corrects the Composition of Gut Microbiota, Promotes SCFA Production, and Suppresses Colon Carcinogenesis. Genes (Basel). 2018 Feb 16;9(2):102. doi: 10.3390/genes9020102.
PubMed 29462896Carretta MD, Quiroga J, Lopez R, Hidalgo MA, Burgos RA. Participation of Short-Chain Fatty Acids and Their Receptors in Gut Inflammation and Colon Cancer. Front Physiol. 2021 Apr 8;12:662739. doi: 10.3389/fphys.2021.662739. eCollection 2021.
PubMed 33897470Tan J, McKenzie C, Potamitis M, Thorburn AN, Mackay CR, Macia L. The role of short-chain fatty acids in health and disease. Adv Immunol. 2014;121:91-119. doi: 10.1016/B978-0-12-800100-4.00003-9.
PubMed 24388214Kruse HP, Kleessen B, Blaut M. Effects of inulin on faecal bifidobacteria in human subjects. Br J Nutr. 1999 Nov;82(5):375-82. doi: 10.1017/s0007114599001622.
PubMed 10673910Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.
PubMed 34353864Li 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 32811478Murphy J, Stacey D, Crook J, Thompson B, Panetta D. Testing control of radiation-induced diarrhea with a psyllium bulking agent: a pilot study. Can Oncol Nurs J. 2000 Summer;10(3):96-100. doi: 10.5737/1181912x10396100.
PubMed 11894282
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Fibre Supplementation to Delay Disease Progression in Early Prostate Cancer
- ClinicalTrials.gov ID
- NCT07790003
- Acronym / sponsor ID
- DEFINITE / 1234567890
- Keywords
- Active Surveillance, Dietary Fibre Modification, Prostate Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of AberdeenUniversity, hospital or other
- Collaborators
- Friends of ANCHOR
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 2024 (actual)
- First posted
- 27 Aug 2026 (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.
This qualitative research study, based on semi-structured interviews and a focus group, aims to explore the attitudes of prostate cancer patients on active surveillance (AS) towards dietary fibre supplementation, given the potential benefits demonstrated in previous research. Prostate cancer patients on AS, often overlooked in the literature, experience cyclical anxiety, particularly regarding disease progression. Lifestyle modifications, including dietary changes, are pursued by a number of these patients as a preventative measure. Dietary fibre such as inulin and psyllium have promising results in studies of pelvic cancers. However, it is important to note that these findings do not directly apply to patients who are currently undergoing AS for prostate cancer. Despite potential side effects, these dietary fibres may contribute to anti-inflammatory and antitumorigenic effects.
Building on this evidence, the investigators aim to explore patient perspectives on the feasibility and acceptability of dietary fibre supplementation during AS. The insights gained will guide the development of a feasibility and/or pilot studies and, subsequently, a multicentre randomised controlled trial. If successful, this intervention could potentially reshape clinical practice for patients with prostate cancer on AS.
Detailed description
Active surveillance (AS) is commonly recommended for men diagnosed with localised prostate cancer who have a low risk of tumour spread. If the prostate cancer progresses to a more aggressive form, this will require active treatment - typically surgical removal of the prostate (radical prostatectomy) or radical radiotherapy to the prostate.
At Aberdeen Royal Infirmary (ARI) Urological unit, the AS protocol involves repeat MRI scans and biopsies being performed at the end of year 1, followed by subsequent radiological and histological investigations every two years, accompanied by either 3- or 6-monthly routine monitoring of specific biochemical (i.e. prostate-specific antigen) levels. In other words, AS is a clinical pathway that aims to monitor early prostate cancer, rather than treating it straight away.
Men undergoing AS, an often-overlooked group in the literature, experience certain levels of cyclical anxiety. This cohort may experience persistent apprehension regarding disease progression, with the fear lingering in the background of their thoughts. Anxiety intensifies around routine appointments with the AS protocol, and new concerns may emerge, particularly relating to fluctuations in their PSA levels. In a recent descriptive analysis, it was found that out of the 43.6% of men who discontinued AS after five years, roughly 12.8% of dropouts occurred because they converted to active treatment without any evidence of disease progression. Therefore, a considerable number of patients exhibit a strong inclination to actively engage in lifestyle modifications in an effort to attempt the prevention of disease progression. This approach includes an interest in modifying their dietary habits.
Dietary fibre, such as psyllium and inulin, are non-digestible carbohydrates that are found in fruits, vegetables, whole grains and legumes. The gut microbiota anaerobically ferments dietary fibre, producing short-chain fatty acids (SCFAs), including acetate, propionate and butyrate. SCFAs play a pivotal role in the intricate relationship between food, gut microbiota and health, exhibiting notable anti-inflammatory and anti-tumorigenic properties.
In a population-based case-only study conducted in the USA, higher fibre intake was inversely associated with prostate cancer aggressiveness (odds ratios 0.70, 95% confidence interval 0.50-0.97 and 0.61 95% CI 0.40-0.93, for 2nd and 3rd tertiles of total fibre intake, respectively). Additionally, a prospective phase II dietary intervention study, using the fibre supplement modified citrus pectin in men with non-metastatic prostate cancer who had biochemically relapsed, showed promising results. 78% of men responded to the therapy, with 58% having a decreased or stable PSA and 75% an improvement in PSA doubling time (PSADT), and median PSADT was significantly improved (p=0.003).
The Kiltie Lab and others have demonstrated the benefit of the rapidly fermented, soluble dietary fibre inulin in controlling tumour growth in mice compared to low dietary fibre intake, in a range of tumour types (including prostate, colorectal cancer and bladder cancer). However, this can come at the expense of side effects in humans including flatulence and bloatedness. Psyllium is another fibre which is commonly used to treat constipation but it is also widely used to treat the diarrhoea caused by radiotherapy to the prostate region. Recently, the addition of psyllium was found to significantly reduce gas production in the colon from the fermentation of inulin, in human subjects with irritable bowel syndrome.
Given this body of evidence, the investigators would like to explore and evaluate the attitudes of patients regarding the potential of dietary fibre supplementation during AS. It is hoped that this qualitative research will provide valuable insights that will support and inform the development of a pilot and feasibility studies on dietary fibre supplementation for prostate cancer patients on AS, delaying the time to active treatment or obviating its use. Subsequently, the intention is to establish a UK multicentre, randomised controlled trial. This may subsequently change clinical practice for patients with prostate cancer on AS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with prostate cancer on active surveillance. | – | Other: Qualitative semi-structured interviews, Other: Focus groupQualitative semi-structured interviews and a focus group with patients who have prostate cancer and are currently on active surveillance. Intervention: Other: Qualitative interviews and focus group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Age groups
- Adult, Older adult
- Study population
- Men on active surveillance for prostate cancer from North-East Scotland.
Key inclusion criteria (4 listed)
- Participants over 18 years of age.
- Participants with residence in North-East Scotland.
- Participants must be fluent in the English language.
- Participants on active surveillance.
Key exclusion criteria (3 listed)
- Participants who do not speak fluent English will be excluded from this study.
- Participants who were treated with surgery, radiotherapy, chemotherapy or anti-androgen therapy for their prostate cancer.
- Vulnerable participants, classified as adults who do not have the capacity to consent for themselves, will not be included in the study. If the research team are made aware that someone has lost capacity then they will be withdrawn from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualitative semi-structured interviewsThe research fellow will conduct a total of 12 semi-structured individual interviews, either via video (MS Teams) or telephone format, based on participant preference. The investigators will employ a semi-structured interview methodology as it collects richer data and allows for in-depth exploration of the participant's insights. Interviews will be conducted at a time convenient to the participant. The topic guide will structure the interview format. Each participant will be interviewed only once. | Other | Patients with prostate cancer on active surveillance. |
| Focus groupSubsequently, the investigators will hold one focus group online via video (MS Teams) with six participants, which will be run by the research fellow and one of the academic supervisors. The topic guide will structure the interview format. | Other | Patients with prostate cancer on active surveillance. |
Primary outcome
Attitudes and preferences of men on active surveillance for prostate cancer regarding dietary supplementation.
Time frame: At a single interview following enrolment (approximately 30-45 minutes)
Semi-structured interviews will explore men's views on incorporating dietary fibre supplementation (inulin with or without psyllium), into active surveillance for prostate cancer. Responses will be analysed thematically using the Theoretical Framework of Acceptability.
1 secondary outcome
Barriers/facilitators to dietary fibre adherence during active surveillance
Time frame: At a single interview following enrolment (approximately 30-45 minutes)
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 31 Aug 2026.
- Background: PubMed 30385049Van Hemelrijck M, Ji X, Helleman J, Roobol MJ, van der Linden W, Nieboer D, Bangma CH, Frydenberg M, Rannikko A, Lee LS, Gnanapragasam VJ, Kattan MW; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium; Members of the Movember Foundation's Global Action Plan Prostate Cancer Active Surveillance GAP3 consortium. Reasons for Discontinuing Active Surveillance: Assessment of 21 Centres in 12 Countries in the Movember GAP3 Consortium. Eur Urol. 2019 Mar;75(3):523-531. doi: 10.1016/j.eururo.2018.10.025. Epub 2018 Oct 29.
- Background: PubMed 16413347Daubenmier JJ, Weidner G, Marlin R, Crutchfield L, Dunn-Emke S, Chi C, Gao B, Carroll P, Ornish D. Lifestyle and health-related quality of life of men with prostate cancer managed with active surveillance. Urology. 2006 Jan;67(1):125-30. doi: 10.1016/j.urology.2005.07.056.
- Background: PubMed 37334023Dovey Z, Horowitz A, Waingankar N. The influence of lifestyle changes (diet, exercise and stress reduction) on prostate cancer tumour biology and patient outcomes: A systematic review. BJUI Compass. 2023 Apr 6;4(4):385-416. doi: 10.1002/bco2.237. eCollection 2023 Jul.
- Background: PubMed 29462896Bishehsari F, Engen PA, Preite NZ, Tuncil YE, Naqib A, Shaikh M, Rossi M, Wilber S, Green SJ, Hamaker BR, Khazaie K, Voigt RM, Forsyth CB, Keshavarzian A. Dietary Fiber Treatment Corrects the Composition of Gut Microbiota, Promotes SCFA Production, and Suppresses Colon Carcinogenesis. Genes (Basel). 2018 Feb 16;9(2):102. doi: 10.3390/genes9020102.
- Background: PubMed 33897470Carretta MD, Quiroga J, Lopez R, Hidalgo MA, Burgos RA. Participation of Short-Chain Fatty Acids and Their Receptors in Gut Inflammation and Colon Cancer. Front Physiol. 2021 Apr 8;12:662739. doi: 10.3389/fphys.2021.662739. eCollection 2021.
- Background: PubMed 24388214Tan J, McKenzie C, Potamitis M, Thorburn AN, Mackay CR, Macia L. The role of short-chain fatty acids in health and disease. Adv Immunol. 2014;121:91-119. doi: 10.1016/B978-0-12-800100-4.00003-9.
- Background: PubMed 10673910Kruse HP, Kleessen B, Blaut M. Effects of inulin on faecal bifidobacteria in human subjects. Br J Nutr. 1999 Nov;82(5):375-82. doi: 10.1017/s0007114599001622.
- Background: PubMed 34353864Gunn D, Abbas Z, Harris HC, Major G, Hoad C, Gowland P, Marciani L, Gill SK, Warren FJ, Rossi M, Remes-Troche JM, Whelan K, Spiller RC. Psyllium reduces inulin-induced colonic gas production in IBS: MRI and in vitro fermentation studies. Gut. 2022 May;71(5):919-927. doi: 10.1136/gutjnl-2021-324784. Epub 2021 Aug 5.
- Background: 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.
- Background: PubMed 32811478Then 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.
- Background: PubMed 11894282Murphy J, Stacey D, Crook J, Thompson B, Panetta D. Testing control of radiation-induced diarrhea with a psyllium bulking agent: a pilot study. Can Oncol Nurs J. 2000 Summer;10(3):96-100. doi: 10.5737/1181912x10396100.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 and Prostatic Neoplasm, 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 4 inclusion and 3 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 31 Aug 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?
Attitudes and preferences of men on active surveillance for prostate cancer regarding dietary supplementation. (time frame: At a single interview following enrolment (approximately 30-45 minutes)). 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 NCT07790003, which also lists 11 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 31 Aug 2026.