The effects of synbiotic supplementation on dietary intake?nutritional status, quality of life, serum Matrix Metalloproteinase enzymes,serum inflammatory markers levels(TNFa,IL-6) and side effects of treatment in rectal cancer patients undergoing neoadjuvant chemoradiotherapy

The effect of synbiotic supplementation on dietary intake, nutritional status, quality of life, serum matrix metalloproteinase, serum inflammatory factors(TNFa,IL-6) and side effect of treatments in rectal patients undergoing neoadjuvant chemoradiotherapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201503181197N18

Enrollment

Registered

2015-06-14

Start date

2015-05-22

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

Rectal cancer. Malignant neoplasm of rectum

Interventions

Intervention 1: Intervention group: Protexin synbiotic capsules ( 2 x 108 CFU Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus

Prevention

Placebo

Intervention group: Protexin synbiotic capsules ( 2 x 108 CFU Lactobacillus casei, Lactobacillus rhamnosus, Streptococcus thermophilus, Bifidobacterium breve, Lactobacillus acidophilus, Bifidobacteri

Control group: 2 placebo capsules a day for 6 weeks. The intervention begins 1 week before starting radiotherapy to the end of radiotherapy.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Inclusion criteria: patients with rectal cancer in stage 2 and 3 undergoing preoperative radiotherapy combined with chemotherapy. Exclusion criteria: clinically relevant pulmonary; cardiovascular; hepatic and kidney dysfunction; immunological disorders; pregnancy; lactation; ongoing or recent infections (within last 30 d); body mass index less than 18.5 ; treatment with anticoagulants; taking antibiotics in the last 3 week; usage of Probiotics or prebiotics or synbiotic and mineral supplements; intolerance of synbiotic supplement.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Serum inflammatory factor TNFa, serum inflammatory factor IL-6. Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: Immunoturbidimetry.	—

Secondary

Measure	Time frame
Dietary intake. Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: 24 hour food recall and dietary record questionnaire.;Quality of life. Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: QLQ-30 questionnaire.;Serum Matrix Metalloproteinases 2 ,9 (MMP-2,9). Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: MMP-2,9;kit.;Added at 2016-02-28: side effects of treatment?. Timepoint: Added at 2016-02-28: before radiotherapy and at the end of intervention. Method of measurement: Added at 2016-02-28: PG-SGA and WHO toxicity criteria questionnaire.	—

Measure

Time frame

Dietary intake. Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: 24 hour food recall and dietary record questionnaire.;Quality of life. Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: QLQ-30 questionnaire.;Serum Matrix Metalloproteinases 2 ,9 (MMP-2,9). Timepoint: Before radiotherapy and at the end of intervention(6 weeks). Method of measurement: MMP-2,9;kit.;Added at 2016-02-28: side effects of treatment?. Timepoint: Added at 2016-02-28: before radiotherapy and at the end of intervention. Method of measurement: Added at 2016-02-28: PG-SGA and WHO toxicity criteria questionnaire.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr. Reza Mahdavi

Facualty of Health and Nutrition

Mahdavir@tbzmed.ac.ir? mahdavirez@hotmail.com+98 41 3335 5282

Outcome results

None listed

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