Clinical trial · Observational
Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome
Investigating the Effect of Pelvic Radiotherapy on the Intestinal Microbiome and Metabolome to Improve the Detection and Management of Gastrointestinal (GI) Toxicity.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Eight in ten patients will develop bowel problems during radiotherapy, eg diarrhoea, pain and incontinence, half will develop difficult long-term bowel problems. It is not known why some people get bowel problems and others do not and there is no test to predict who will develop bowel problems following their treatment. There is a link between the changes in the number and type of gut bacteria (the microbiome) in some bowel conditions and it is possible to test for these different bacteria in a simple stool sample using genetic testing. Also gut bacteria produce different gases in the stool called "volatile organic compounds" (VOCs), which can be measured in stool samples. Specific VOC patterns have been seen in other bowel conditions and small studies suggesting that there are specific VOC and gut bacteria patterns in the stool of those undergoing pelvic radiotherapy which may help to identify people who will get difficult bowel problems. Diet can change the microbiome/VOCs so diet change could improve bowel symptoms after radiotherapy. The investigators would like to test stool samples of patients with womb, cervix or bladder cancer having pelvic radiotherapy to see if there are differences in the number/type of gut bacteria and VOCs between those who get severe bowel symptoms compared to those with mild bowel symptoms. They also want to see whether these differences in VOCs or gut bacteria can tell who will develop severe bowel symptoms during or after radiotherapy and determine the effect of diet. The first step is to run the study on a small scale to confirm that a larger study would work. This will make sure the investigators can recruit and consent people safely and will test the best ways of measuring bowels symptoms using several questionnaire options. They will collect the information needed to work out how many people would be needed in a large trial to fully test the theory. Ultimately, the investigators would like to use differences in the number/type of gut bacteria and VOCs to find ways to better prevent and treat bowel problems after pelvic radiotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Urinary Bladder Neoplasms | Bladder Neoplasm | ALIAS | 0.90 |
| Uterine Cervical Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- EPRIMM study participants
- description
- No intervention: Questionnaires, food diaries and stool sample.
Primary outcomes (6)
- measure
- Rate of recruitment
- timeFrame
- 12 months
- description
- Recruitment rates: can we achieve sufficient recruitment to the study? Are patients willing to participate?
- measure
- Acceptability of recruitment
- timeFrame
- 12 months
- description
- Acceptability of recruitment process to patient cohort measured using internally generated non-validated questionnaire led by the research nurse
- measure
- Patient experience of study
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pelvic radiotherapy-cervix/endometrial/bladder cancer. * ≥18 years. * Able to consent. * Able to complete questionnaires. Exclusion Criteria: * Pre-existing GI disease * Abdominopelvic surgery within preceding 4 weeks
References
Publications (23)
- BACKGROUNDWedlake L, Thomas K, McGough C, Andreyev HJ. Small bowel bacterial overgrowth and lactose intolerance during radical pelvic radiotherapy: An observational study. Eur J Cancer. 2008 Oct;44(15):2212-7. doi: 10.1016/j.ejca.2008.07.018. Epub 2008 Aug 27. PMID 18760593
- BACKGROUNDAndreyev J. Gastrointestinal symptoms after pelvic radiotherapy: a new understanding to improve management of symptomatic patients. Lancet Oncol. 2007 Nov;8(11):1007-17. doi: 10.1016/S1470-2045(07)70341-8. PMID 17976611
- BACKGROUNDGami B, Harrington K, Blake P, Dearnaley D, Tait D, Davies J, Norman AR, Andreyev HJ. How patients manage gastrointestinal symptoms after pelvic radiotherapy. Aliment Pharmacol Ther. 2003 Nov 15;18(10):987-94. doi: 10.1046/j.1365-2036.2003.01760.x. PMID 14616164
- BACKGROUNDNam YD, Kim HJ, Seo JG, Kang SW, Bae JW. Impact of pelvic radiotherapy on gut microbiota of gynecological cancer patients revealed by massive pyrosequencing. PLoS One. 2013 Dec 18;8(12):e82659. doi: 10.1371/journal.pone.0082659. eCollection 2013. PMID 24367534
- BACKGROUNDLam V, Moulder JE, Salzman NH, Dubinsky EA, Andersen GL, Baker JE. Intestinal microbiota as novel biomarkers of prior radiation exposure. Radiat Res. 2012 May;177(5):573-83. doi: 10.1667/rr2691.1. Epub 2012 Mar 23. PMID 22439602
- BACKGROUNDKim YS, Kim J, Park SJ. High-throughput 16S rRNA gene sequencing reveals alterations of mouse intestinal microbiota after radiotherapy. Anaerobe. 2015 Jun;33:1-7. doi: 10.1016/j.anaerobe.2015.01.004. Epub 2015 Jan 16. PMID 25600706
- BACKGROUNDManichanh C, Varela E, Martinez C, Antolin M, Llopis M, Dore J, Giralt J, Guarner F, Malagelada JR. The gut microbiota predispose to the pathophysiology of acute postradiotherapy diarrhea. Am J Gastroenterol. 2008 Jul;103(7):1754-61. doi: 10.1111/j.1572-0241.2008.01868.x. Epub 2008 Jun 28.