The effects of Lactobacillus acidophilus probiotic capsule administration on the immune system and treatment efficacy in patients with rectal cancer

Effects of Lactobacillus acidophilus probiotic as an adjuvant therapy with the standard treatments on the immune system and treatment efficacy in patients with locally advanced rectal cancer: Phase III randomized clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT2016061118745N8

Enrollment

150

Registered

2016-06-28

Start date

2016-06-21

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

locally advanced rectal cancer. Malignant neoplasm of rectum

Interventions

Intervention 1: Intervention group: The case group will receive Lactobacillus acidophilus capsule (1.5 g/daily, produced by Zist Takhmir Co) from one day before chemo-radiation to one week before surg

Treatment - Drugs

Intervention group: The case group will receive Lactobacillus acidophilus capsule (1.5 g/daily, produced by Zist Takhmir Co) from one day before chemo-radiation to one week before surgery for 13 weeks

Control group will receive the placebo capsules from one day before chemo-radiation to one week before surgery for 13 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria : Patient with locally advanced rectal cancer ; Patient with non-metastatic rectal cancer; Voluntary participation in the study and informed consent form fulfilling; Lack of swallowing disorder. Exclusion criteria : Patients with other cancers; Patients with renal and hepatic disorders; Patients with intestinal obstruction; Patients with low level of white blood cells (less than 1000 cells per mm3); Patients with drug intolerance or drug sensitivity to probiotics.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Destroy of tumor or decrease of tumor size. Timepoint: The beginning and end of the study. Method of measurement: CT.	—

Secondary

Measure	Time frame
STAT4 gene expression. Timepoint: The beginning and end of the study. Method of measurement: Real-time PCR.;The serum levels of cytokines. Timepoint: The beginning and end of the study. Method of measurement: ELISA technique.;CDs measurement. Timepoint: The beginning and end of the study. Method of measurement: Flowcytometry.	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Ali Mohammad Alizadeh

Cancer Research Center, Cancer Institute of IR. Iran, Imam Khomeini Hospital

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

Outcome results

None listed

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