Clinical trial · Interventional
Study to Prevent Radiation Induced Damage to Bowel Using a Prebiotic Enhanced Diet.
A Double-blind Placebo-controlled Trial of Dietary Supplementation With 15g/Day FOS for Five Weeks in Patients With Endometrial/Cervical Carcinoma or 7.5 Weeks in Patients With Prostate Carcinoma Undergoing Pelvic Radiotherapy.
- 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)
The study will consist of pair of double-blind placebo-controlled trials of dietary supplementation with 15g/day FructoOligoSaccharide (FOS) for 7.5 weeks in patients with prostate carcinoma or 5 weeks in patients with cervical or endometrial carcinoma who are to undergo pelvic radiotherapy with intent to cure.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Radiation Enteritis | — | UNRESOLVED | — |
| Radiation Proctitis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| FructoOligoSaccharide | Dietary Supplement | — | UNRESOLVED |
| Maltodextrin | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- FOS
- description
- Prebiotic (FructoOligoSaccharide-FOS.
- interventionNames
- Dietary Supplement: FructoOligoSaccharide
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Maltodextrin (non-prebiotic carbohydrate).
- interventionNames
- Dietary Supplement: Maltodextrin
Primary outcomes (1)
- measure
- Gastrointestinal Status
- timeFrame
- 5 weeks or 7.5 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * The study group will comprise men and women aged 18 years or older with a histologically proven diagnosis of carcinoma of the prostate or carcinoma of the cervix or endometrium in whom radical radiotherapy has been selected in their treatment plan following assessment by the prostate oncology or gynecological oncology multidisciplinary team Exclusion Criteria: * Exclusion criteria will preclude the recruitment of those having radiotherapy for purely palliative reasons. Patients known to have a current infection with an enteric pathogen, or who have used antibiotics within the past month, consumed any probiotic or prebiotic within the last month, or used any rectal/topical therapy within the last month will also be ineligible. Those known or suspected to have inflammatory bowel disease (ulcerative colitis or Crohn's disease) will be ineligible. Patients requiring hospitalisation, and those considered by the chief investigator (CI) to have important hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease will also be ineligible.
References
Publications (0)
Data not yet available