Effects of Multistrain Probiotic Supplementation During Neoadjuvant Chemoradiotherapy in Patients With Colorectal Cancer: A Randomized Placebo-Controlled Study
Sponsor study identifier
interventional
58
1 country
1
Study Start
November 1, 2015
Actual (reported)Primary Completion
July 10, 2019
Actual (reported)Study Completion
July 10, 2019
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 10, 2019
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2015
Actual (reported)July 10, 2019
Actual (reported)July 10, 2019
Actual (reported)October 1, 2026
Actual (reported)October 7, 2026
Actual (reported)Gut microbiota composition and diversity
Gut microbiota composition and diversity assessed in fecal samples using 16S rRNA gene sequencing, including alpha diversity, beta diversity, and taxonomic composition.
At baseline (T0), week 2 (T1), week 5/end of treatment (T2), and seven weeks after completion of treatment (T3).
Fecal short-chain fatty acid concentrations
Baseline (T0) and 7 weeks after treatment completion (T3).
Serum inflammatory cytokine concentrations
Baseline (T0) and 7 weeks after treatment completion (T3).
Circulating zonulin concentration as a marker of intestinal permeability
Baseline (T0) and 7 weeks after treatment completion (T3).
Health-related quality of life and gastrointestinal symptoms assessed using the EORTC QLQ-C30
7 weeks after treatment completion (T3).
Participants received a multistrain probiotic formulation orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
Participants received a placebo orally twice daily for five weeks during neoadjuvant chemoradiotherapy.
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 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.
Virgen de la Victoria University Hospital
Málaga, Málaga, 29010, Spain
Chitapanarux I, Chitapanarux T, Traisathit P, Kudumpee S, Tharavichitkul E, Lorvidhaya V. Randomized controlled trial of live lactobacillus acidophilus plus bifidobacterium bifidum in prophylaxis of diarrhea during radiotherapy in cervical cancer patients. Radiat Oncol. 2010 May 5;5:31. doi: 10.1186/1748-717X-5-31.
María Isabel Queipo Ortuño, PhD
University of Malaga
58 participants (actual enrollment reported by the registry).
First Submitted
October 1, 2026
First Posted
October 7, 2026
Study Start
November 1, 2015
Actual (reported)An Evaluation of Probiotic in the Clinical Course of Patients With Colorectal Cancer
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Primary Completion
July 10, 2019
Actual (reported)Study Completion
July 10, 2019
Actual (reported)Last Updated
October 7, 2026
Record last verified: 2026-10
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Source: ClinicalTrials.gov.
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