Skip to content

he Effects of probiotic supplementation on related side effects after chemotherapy laboratory symptoms and in metastatic gastrointestinal cancer

The Effects of probiotic supplementation on related side effects after chemotherapy and laboratory symptoms in metastatic gastrointestinal cancer patients:A randomized control trial

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20240629062278N1
Enrollment
160
Registered
2024-07-03
Start date
2024-07-05
Completion date
Unknown
Last updated
2024-07-22

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

Conditions

GI Metastatic Cancer. Personal history of malignant neoplasm

Interventions

Intervention 1: Intervention group: Take one probiotic capsule (500 mg) containing casei, lactobacillus acidophilus, lactobacillus rhamnosus, lactobacillus bulgaricus, bifidobacterium breve, bifidobac

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 65-18 years old with metastatic GI cancer undergoing chemotherapy No lactose intolerance Did not have any symptoms of diarrhea, constipation, nausea, vomiting, or mucositis before receiving chemotherapy, Functional status 0 or 1 according to ECOG (Eastern Cooperative Oncology Group)

Exclusion criteria

Exclusion criteria: Reluctance of the patient to participate in the study Description of underlying diseases including IBD \History of Colectomy Taking any antibiotic or other drugs

Design outcomes

Primary

MeasureTime frame
Examination of gastrointestinal symptoms: examination of changes in the severity of symptoms up to three chemotherapy courses (equivalent to 3 months) compared to zero time. Timepoint: Zero time & 3 months later. Method of measurement: The severity of diarrhea is described using the CTCAE Common Terms for Adverse Events criteria (NCI, National Cancer Institute). The severity of mucositis according to the CTCAE criteria.The type and severity of constipation based on the criteria (BRISTOL BSFS).;Examining inflammatory factors and tumor markers: Examining the changes three and six months after the intervention compared to zero time. Timepoint: Zero time, 3 and 6 months later. Method of measurement: laboratory evaluation.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNiusha Nosrati

Shahid Beheshti University of Medical Sciences

niushanosrati72@gmail.com+98 21 7343 0000

Outcome results

None listed

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