Clinical trial · Interventional
Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy Among Colorectal Cancer Patients
Effect of Probiotics Supplementation on the Side Effects of Radiation Therapy on the Immune System Among Colorectal Cancer Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): This study was closed without recruitment
Summary
Brief summary (as posted)
Colorectal cancer (CRC) is one of the most common types of cancer worldwide in general and in Jordan in specific. The studies that investigate the role of Probiotics supplementation in improving the inflammatory response, gastrointestinal toxicity and life quality of patients with colorectal cancer during radiotherapy are limited. So, this study aimed to study the effect of probiotics on the response of inflammatory markers, gastrointestinal toxicity, and quality of life in patients with colorectal cancer during radiation therapy. An interventional double-blind randomized clinical trial (RCT) design will be used in this study. Forty patients will be recruited and assigned either to receive 3 times a day probiotic supplement or to be control with no intervention. The demographic data, anthropometric measurements, Cancer Quality of Life Questionnaire and blood samples will be collected at baseline and at end of radiation therapy. Interleukin-6, interleukin-1,interleukin-10 IL-10, C-reactive protein, tumor necrosis factor-alpha and complete blood count (CBC) will be measured. The results will approve or disapprove the beneficial effect of using probiotics as adjuvant therapy for CRC patients and other types of cancer to reduce the side effects of radiotherapy and raise body weight as well as improving their quality of life.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Drug | — | UNRESOLVED |
| Probiotic Formula Capsule | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Probiotic Formula Capsule
- description
- In this intervention arm the patients will receive oral viable capsules of probiotic contain (1\*10 10 colony forming unit (CFU)/g) of lactobacillus (Lactobacillus rhamnosus , Lactobacillus acidophilus , Lactobacillus reuteri, Lactobacillus paracasei, Lactobacillus casei, Lactobacillus gasseri, Lactobacillus plantarum) and bifidobacteria (Bifidobacterium lactis, Bifidobacterium breve, Bifidobacterium bifidum, Bifidobacterium longum, Bifidobacterium infantis) species three times a per day
- interventionNames
- Dietary Supplement: Probiotic Formula Capsule
- type
- OTHER
- label
- Control
- description
- In this intervention arm, the control arm will receive normal treatment without any probiotic
- interventionNames
- Drug: Control
Primary outcomes (8)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 35 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: 1. Men or women, 2. Aged from 35- 65 years with histologically proven CRC and 3. Histologically proven CRC with stage I, II, III 4. Will exposed newly to radiotherapy with the absence of any psychological, sociological or geographical condition that potentially affects the compliance with the study protocol and follow-up schedule. Exclusion Criteria: 1. Active infection treated by antibiotic therapy or recent infection or recent antibiotic use; 2. Severe cardiovascular and cerebrovascular diseases that could not tolerate radical surgery; 3. Recent use of probiotics, prebiotics, or synbiotic; 4. Evidence of immunodeficiency; 5. Cancer stage IV 6. Pregnancy, 7. Recent/concurrent admission to ER 8. Co-existence of other malignant neoplasms, no other type of cancer in the past 5 years, any serious concomitant systemic disorders or diseases incompatible with the study.
References
Publications (10)
- BACKGROUNDAbayomi J, Kirwan J, Hackett A. The prevalence of chronic radiation enteritis following radiotherapy for cervical or endometrial cancer and its impact on quality of life. Eur J Oncol Nurs. 2009 Sep;13(4):262-7. doi: 10.1016/j.ejon.2009.02.007. Epub 2009 Jul 28. PMID 19640788
- BACKGROUNDAbdollahi H. Probiotic-based protection of normal tissues during radiotherapy. Nutrition. 2014 Apr;30(4):495-6. doi: 10.1016/j.nut.2013.09.006. No abstract available. PMID 24607309
- BACKGROUNDAbdollahi, H., Shiri, I., Atashzar, M., Sarebani, M., Moloudi, K., and Samadian, H. (2015), Radiation protection and secondary cancer prevention using biological radioprotectors in radiotherapy. International Journal of Cancer Therapy and Oncology, 3(3).
- BACKGROUNDAmbalam P, Raman M, Purama RK, Doble M. Probiotics, prebiotics and colorectal cancer prevention. Best Pract Res Clin Gastroenterol. 2016 Feb;30(1):119-31. doi: 10.1016/j.bpg.2016.02.009. Epub 2016 Feb 19. PMID 27048903
- BACKGROUNDBowen JM, Stringer AM, Gibson RJ, Yeoh AS, Hannam S, Keefe DM. VSL#3 probiotic treatment reduces chemotherapy-induced diarrhea and weight loss. Cancer Biol Ther. 2007 Sep;6(9):1449-54. doi: 10.4161/cbt.6.9.4622. Epub 2007 Jun 23. PMID 17881902
- BACKGROUNDCiernikova S, Mego M, Semanova M, Wachsmannova L, Adamcikova Z, Stevurkova V, Drgona L, Zajac V. Probiotic Survey in Cancer Patients Treated in the Outpatient Department in a Comprehensive Cancer Center. Integr Cancer Ther. 2017 Jun;16(2):188-195. doi: 10.1177/1534735416643828. Epub 2016 May 5. PMID 27151581
- BACKGROUNDCiorba MA, Hallemeier CL, Stenson WF, Parikh PJ. Probiotics to prevent gastrointestinal toxicity from cancer therapy: an interpretive review and call to action. Curr Opin Support Palliat Care. 2015 Jun;9(2):157-62. doi: 10.1097/SPC.0000000000000134. PMID 25872116