Clinical trial · Interventional
The Effects of Probiotics on Intestinal Permeability in Gastrointestinal Cancer Patients in Chemotherapy
NCT03704727CI-TRIAL-00038237completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to test the hypothesis that adjuvant administration of probiotics in cancer patients undergoing chemotherapy can reduce a chemo-induced increased intestinal permeability. Furthermore, we hypothesize that the use of probiotics may reduce the occurrence of gastrointestinal side effects such as diarrhea, abdominal pains, bacterial translocation and infections following chemotherapy.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastrointestinal Irritation | — | UNRESOLVED | — |
| Intestinal Permeability | — | UNRESOLVED | — |
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Probiotic | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- probiotic treatment
- description
- Probiotic: VSL#3 is a probiotic formula containing a mixture of 9x10\^10 CFU/g Lactobacilli strains (Lactobacillus acidophilus, Lactobacillus plantarum, Lactobacillus casei, and Lactobacillus bulgaricus), 8x10\^10 CFU/g Bifidum strains (Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium infantis) and 20x10\^10 CFU/g Streptococcus thermophilus. Administred orally
- interventionNames
- Dietary Supplement: Probiotic
Primary outcomes (1)
- measure
- Intestinal permeability
- timeFrame
- 4 hours
- description
- Urinary lactulose-mannitol test
Secondary outcomes (1)
- measure
- Gastrointestinal adverse events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * GI cancer (all types) patients undergoing chemotherapy in oncologic department at Rigshospitalet in Copenhagen * Age \>18 years * Patients with at least three planned chemo therapy sessions left Exclusion Criteria: * Pregnant * Patients who don't speak, write or understand Danish * Known inflammatory bowel diseases or malabsorption * Chronic kidney disease (2 x upper limit plasma creatinine) * Neutropenia (\< 1.5 x 109/L neutrophilic granulocytes in peripheral blood) * Use of antibiotics * Use of lactulose (laxative) and not able to discontinue three days prior to urin collection (lactulose/mannitol test) * Use of probiotics
References
Publications (0)
Data not yet available
No reference posted for this study.