Clinical trial · Interventional
Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Pts(Get Pelvic/Abdominal Rtx)
Double Blind Placebo Controled Randomized Trial, Effects of Probiotics Supplementation on Intestinal Microbiome in Malignancy Patients Who Get Pelvic/Abdominal Radiotherapy
NCT01706393CI-TRIAL-00010087RTxIMprobiounknownN/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 purpose of this study is to evaluate the effect of probiotics to improve the intestinal microbiome in malignancy patients who get pelvic/abdominal radiotherapy.
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 |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Dietary Supplement | — | UNRESOLVED |
| probiotics (six probiotic cultures) | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- probiotics
- description
- Probiotics supplementation group. Probiotics intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Probiotics is composed of Lactobacillus acidophilus, Streptococcus thermophilus, Bifidobacterium lactis, L. rhamnosus, B. longum and B. bifidum.
- interventionNames
- Dietary Supplement: probiotics (six probiotic cultures)
- type
- PLACEBO_COMPARATOR
- label
- placebo
- description
- Placebo group. Placebo intake for 6 weeks(including 5weeks of Rtx) and it take one tablet twice a day. Placebo is composed of starch.Probiotics and placebo were similar in appearance, taste.
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients who current diagnosis of gynecologic cancer or rectal cancer and never previously received radiation therapy and will use for the first time radiotherapy at department of radiation oncology, Seoul National University Hospital. * ECOG performance status (PS) of 0, 1, or 2. * signed written informed consent. * Patients who get pelvic/abdominal radiotherapy. Exclusion Criteria: * People who use antibiotics that can affect intestinal microorganism growth within one month before the study. * Patients who use probiotics within one month before the study. * Patients received neoadjuvant chemotherapy. * Acute enteritis symptoms (diarrhea, abdominal pain, nausea, vomiting) for the patient. * Patients diagnosed with inflammatory bowel disease. * Patients suspected gastrointestinal infections and other infectious diseases. * Suspected infections from blood tests : Excessive rise in WBC, ESR, CRP * Suspected renal insufficiency from blood tests
References
Publications (0)
Data not yet available
No reference posted for this study.