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Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Colorectal Cancer
Sponsor: University of Malaga
Summary
This prospective randomized, double-blind, placebo-controlled study evaluated the effects of multistrain probiotic supplementation in patients with stage II-III colorectal cancer undergoing neoadjuvant chemoradiotherapy. Participants received either a multistrain probiotic or placebo twice daily for five weeks during chemoradiotherapy. The study evaluated changes in gut microbiota composition and diversity, as well as fecal short-chain fatty acids, inflammatory cytokines, zonulin, gastrointestinal symptoms, and quality of life. Participants were assessed at baseline, during treatment, at the end of treatment, and seven weeks after completion of treatment.
Official title: Effects of Multistrain Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Patients With Colorectal Cancer: A Randomized Placebo-Controlled Study
Key Details
Gender
All
Age Range
35 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
58
Start Date
2015-11-01
Completion Date
2019-07-10
Last Updated
2026-10-07
Healthy Volunteers
No
Conditions
Interventions
Multistrain Probiotic Formulation
Multistrain probiotic formulation containing Saccharomyces boulardii 600 mg, Lactobacillus rhamnosus GG 6 × 10\^9 CFU, Lactobacillus helveticus 4 × 10\^9 CFU, Bifidobacterium longum 4 × 10\^9 CFU, fructooligosaccharides 500 mg, and vitamin D3 2.5 μg (100 IU). The probiotic was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
Placebo
Placebo containing fructooligosaccharides 500 mg and vitamin D3 2.5 μg (100 IU), without probiotic strains or yeast. The placebo was administered orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
Locations (1)
Virgen de la Victoria University Hospital
Málaga, Málaga, Spain