Radiotherapy Induced DiarrheaPhase 1/2NCT06783153
Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
A Phase 1/2 study testing Rifaximin 550 MG in people with Radiotherapy Induced Diarrhea and Acute Radiation Enteritis, run by Mansoura University at 1 site in Egypt.
Trial summary
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiotherapy Induced Diarrhea, Acute Radiation Enteritis, Prostate Cancer
- What is being tested?
- Rifaximin 550 MG
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to Dec 2025
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
- Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.
Who cannot join
- Patients who have a record of intestinal resection in their medical history.
- Patients with a medical background of irritable bowel syndrome.
- Patients with a history of inflammatory bowel disease.
- Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
- Patients experiencing diarrhea at the outset of the study.
- Patients with compromised immune systems, such as those who are HIV positive or using immunosuppressive medications.
- Pregnant or lactating woman.
- Patients allergic to rifamycin.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Mansoura University
Al Mansurah, Province, 35516
Noha Mansour, 01221610667, nohamansaur@mans.edu.eg
Noha Mansour
About this study
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.
- Conditions
- Radiotherapy Induced Diarrhea, Acute Radiation Enteritis, Prostate Cancer, Cervical Adenocarcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Rectal Adenocarcinoma
- Being tested
- Rifaximin 550 MG, Standard Care Chemoradiation
- Medical subject headings
- Prostatic Neoplasms, Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rifaximin 550 MGDrug
Oral Rifaximin 550mg twice daily from the start of pelvic radiotherapy, with or without chemotherapy, as a preventive measure, and continuing every day until the end of the treatment up to 5 to seven weeks.
Standard Care ChemoradiationDrug
Patients will receive standard chemotherapy and/or radiation
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Not described Receives: Drug: Standard Care Chemoradiation |
| Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy | Experimental | Not described Receives: Drug: Rifaximin 550 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start20 Jan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiotherapy Induced DiarrheaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Mansour, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783153
- Sponsor's protocol ID
- 2023-238
- Status last verified
- Jan 2025
- First submitted
- 14 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Adjunctive Use of Rifaximin In Preventing Radiotherapy-induced Diarrhea in Cancer Patients
- ClinicalTrials.gov ID
- NCT06783153
- Acronym / sponsor ID
- 2023-238
- Conditions
- Radiotherapy Induced Diarrhea, Acute Radiation Enteritis, Prostate Cancer, Cervical Adenocarcinoma, Bladder (Urothelial, Transitional Cell) Cancer, Rectal Adenocarcinoma
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 20 Jan 2025 (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.
Preclinical data indicate that rifaximin could be repurposed as a novel strategy for preventing and reducing the severity of gastrointestinal damage, particularly diarrhea, that results from pelvic irradiation. So, The aim of the work is to investigate the impact of Rifaximin on the incidence and severity of radiotherapy-induced diarrhea in cancer patients undergoing pelvic irradiation with or without chemotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Drug: Standard Care Chemoradiation |
| Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy | Experimental | Drug: Rifaximin 550 MG |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals who are 18 years of age or older and have been diagnosed with non metastatic pelvic cancers.
- Patients who are undergoing curative intent radiotherapy with or without chemotherapy treatment.
Key exclusion criteria (8 listed)
- Patients who have a record of intestinal resection in their medical history.
- Patients with a medical background of irritable bowel syndrome.
- Patients with a history of inflammatory bowel disease.
- Patients who regularly take anti-diarrheal medications before commencing radiotherapy.
- Patients experiencing diarrhea at the outset of 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 |
|---|---|---|
| Rifaximin 550 MGOral Rifaximin 550mg twice daily from the start of pelvic radiotherapy, with or without chemotherapy, as a preventive measure, and continuing every day until the end of the treatment up to 5 to seven weeks. | Drug | Patients will receive Rifaximin 550 MG in addition to Pelvic Radiotherapy with/not chemotherapy |
| Standard Care ChemoradiationPatients will receive standard chemotherapy and/or radiation | Drug | Control Arm |
Primary outcome
The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation.
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2025.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Rifaximin 550 MG in people with Radiotherapy Induced Diarrhea and Acute Radiation Enteritis, run by Mansoura University at 1 site in Egypt.
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 2 inclusion and 8 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: opening soon, as of the sponsor's last update on 20 Jan 2025. 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 Egypt. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Mansour (01221611667, nohamansaur@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The difference in the incidence and severity of radiotherapy induced diarrhea grade 2 or more according to Common Terminology Criteria for Adverse Events (CTCAE)in cancer patients undergo pelvic irradiation. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2025.