Please select the eligibility criteria that correspond to the clinical trial below.
Title: Effect of a Mixture of Inulin and Fructo-oligosaccharide on Lactobacillus and Bifidobacterium Intestinal Microbiota of Patients Receiving Radiotherapy: a Randomised, Double-blind, Placebo-controlled Trial.
Brief Summary: Abdominal and pelvic radiotherapy (RT) reduces the renewal capacity of the epithelium. Rectal biopsies obtained from patients receiving pelvic RT have revealed atrophy of surface epithelium, acute cryptitis, crypt abscesses, crypt distortion and atrophy, and stromal inflammation. Modifications in intestinal microbiota, such as an increase in the number of pathogens, may contribute to intestinal injury. The prebiotic effect of a carbohydrate is assessed by its capacity to stimulate the proliferation of healthy bacteria (Bifidobacterium, Lactobacillus) rather than pathogenic bacteria (Clostridium, E. coli).

The hypothesis of the study is that a mixture of inulin and fructooligosaccharide could modulate Lactobacillus and Bifidobacterium and reduce the intestinal injury in patients affected of gynaecological cancer and treated with abdominal radiotherapy.


Options:
A: Inclusion Criteria:

* female gender, age ≥ 18 years, and a diagnosis of gynaecologic cancer requiring postoperative pelvic RT.

Exclusion Criteria:

* previous RT, previous or adjuvant chemotherapy, other types of pelvic tumours or other gynaecologic malignancies, antibiotic or immunosuppressive treatment one week before inclusion or during treatment, and the presence of acute or chronic gastrointestinal disease contraindicating ingestion of the fibre
B: Inclusion Criteria:

histological proven carcinoma of the prostate with Gleason score risk of lymphe node involvement of \<15% calculated by the Yale-formula; Risk \[%\] = \[GS -5\] x \[PSA/3 + 1.5 x T\], mit T = 0, 1, and 2 for cT1c, cT2a, und cT2b/cT2c

* Karnofsky-Index ≥ 70%
* age between 40 and 80 years
* PSA

Exclusion Criteria:

Stadium IV (distant metastases) Lymphogenous Metastases hip replacement former irradiation of the pelvis pacemaker defibrillator
C: Inclusion Criteria:

* Histologically proven prostate cancer.
* Surgical candidate for prostatectomy.
* During study period, must agree not to take new supplements.
* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled prostatectomy.
* Must give written and informed consent in accordance with institutional and federal guidelines.

Exclusion Criteria:

During study period, must agree not to take new supplements.

* No concurrent chemotherapy, radiation or hormonal therapy.
* No history of prior allergy to soy based products.
* Must not have been taking soy supplements or soy isoflavones within 90 days prior to study enrollment.
* Must be able to safely be on study supplements for period of at least two weeks prior to scheduled
D: Inclusion Criteria:

* Advanced cervical cancer

Exclusion Criteria:

* Previously treated for cancer of the cervix
* Karnofsky Performance Score less than 50
* Renal dysfunction ( Serum creatinine \> 2.0mg/dl)
* Hepatic dysfunction (Serum bilirubin\> 2.0 mg/dl, transaminases \> 1.5 times normal)
* Pregnant or lactating women: Women will be tested by pregnancy test for possibility of existing pregnancy. Those that meet criteria of trial will be asked to promise that they don't become pregnant; barrier contraception will be recommended.

Answer: A