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Investigating the preventive effect of metronidazole and probiotics on intestinal complications caused by radiotherapy

Investigating the preventive effect of metronidazole and probiotics on intestinal complications caused by radiotherapy with tumor therapy in patients with prostate cancer

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20200825048515N86
Enrollment
75
Registered
2025-10-28
Start date
2025-11-22
Completion date
Unknown
Last updated
2025-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate cancer. Malignant neoplasm of prostate

Interventions

Intervention 1: First intervention group: In addition to radiotherapy, this group will be administered a probiotic sachet orally daily for one week. They will also receive placebo tablets orally for o

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with prostate cancer, requiring radiotherapy with tumor therapy Age group 18 years and above No concurrent radiotherapy with chemotherapy No deep ulcer or rectal stenosis and fistula formation No chronic diarrhea before starting radiotherapy No inflammatory bowel diseases such as IBD, Crohn's, ulcerative colitis No use of narcotics Consent to enter the study

Exclusion criteria

Exclusion criteria: Use of antibiotics before entering the study Having history of previous pelvic radiotherapy Having allergy to the study drugs

Design outcomes

Primary

MeasureTime frame
Acute intestinal complications. Timepoint: Before intervention, 8 and 12 weeks after intervention. Method of measurement: Based on the criteria of European Organisation for Research and Treatment of Cancer/Radiation Therapy Oncology Group (RTOG/EORTC).;Digestive symptoms. Timepoint: Before intervention, 8 and 12 weeks after intervention. Method of measurement: Scale of gastrointestinal symptom rating scale (GSRS).

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNadia Najafizade

Esfarayen University of Medical Sciences

nadianajafizade@yahoo.com+98 31 3235 0210

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026