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Lactobacillus acidophil probiotic effects in rectum cancer patients

Lactobacillus acidophil probiotic effects as an adjunctive therapy together standard drugs on side effects, treatment response and quality of life in patients with rectum cancer: Double Blind Randomized Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2014092118745N3
Enrollment
300
Registered
2014-11-08
Start date
2014-10-01
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Malignant neoplasms of digestive organs. Malignant neoplasm of rectum, anus and anal canal whose point of origin cannot be classified to any one of the categories C20-C21.2

Interventions

Intervention 1: Patients will receive Lactobacillus acidophilus probiotic (capsules 500 mg, three times a day, before each meal) for at least 5 months before to two months after surgery and radiothera
Treatment - Drugs
Placebo
Patients will receive Lactobacillus acidophilus probiotic (capsules 500 mg, three times a day, before each meal) for at least 5 months before to two months after surgery and radiotherapy.
Patients will receive the placebo capsules of Lactobacillus acidophilus probiotic (three times a day, before each meal) for at least 5 months before to two months after surgery and radiotherapy.

Sponsors

Tehran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 70 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Randomized; with obtaining written consent; rectum cancer in neoadjuvant stage. Exclusion criteria: Patients with kidney problems or liver problems; patients with serious heart problems; patients with metastatic lung and brain cancer; patients with intestinal obstruction; patients with GFR less 30; patients with immunodeficiency.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Response to treatment. Timepoint: Before and after drug therapy, 5 months. Method of measurement: CT scan.

Secondary

MeasureTime frame
The assesment of quality of life. Timepoint: Befor and after of treatment, 5 months. Method of measurement: Questionnaires of FACT and CARES.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Mohammad Alizadeh

Tehran University of Medical Sciences

aalizadeh@razi.tums.ac.ir+98 21 6119 2501

Outcome results

None listed

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