Light therapy and taking 1 L. salivarius AP-32 probiotic capsule two times everyday for 7 days.

Light therapy and taking 1 B. Animalis subsp. Lactis CP-9 probiotic capsule two times everyday for 7 days.

Light therapy and taking 1 placebo capsule two times everyday for 7 days.

Hyperbilirubinemia, Neonatal

Taking 1 probiotic capsule two times everyday for 7 days.

Lactobacillus Salivarius AP-32

Bifidobacterium Animalis subspecies Lactis CP-9

Taking 1 placebo capsule two times everyday for 7 days.

Placebo

China Medical University Hospital

The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia

The study will be conducted for 7 days, the serum bilirubin level will be measured every day.

All babies are monitored for adverse events such as vomiting, diarrhea or bloating.

Ming-Luen Tsai

Attending physician

This group will receive standard nutritional guidance from the institutional routine and prebiotics in combination with probiotics, starting one week before the start of Ch-RT and daily throughout the treatment up to 6 to 8 weeks post Ch-RT at the time of evaluation response (primary outcome).

This group will lead nutritionally based just before starting Ch-RT.

Anal Cancer Squamous Cell

Administration of prebiotics in combination with probiotics before the start of Ch-RT

prebiotics in combination with probiotics

AC Camargo Cancer Center

Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)

A Randomized Phase II Study of the Administration of Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy for Patients With Squamous Cell Carcinoma of the Anal Canal (BISQUIT)

absence of visible disease at the clinical examination and magnetic resonance imaging (MRI) of the pelvis (or pelvic tomography, if contraindicated to MRI) and without disease at a distance, through tomography of the chest and abdomen.

Comparing the mean pre-and post-Ch-RT volume-capture measurements of each patient at 6-8 weeks post Ch-RT

defined as absence of disease visible to clinical and pelvic MRI (or pelvic tomography) exams and without disease at a distance, through tomography of the chest and abdomen;

defined as the time from day1 cycle 1 of Ch-RT treatment to local or remote relapse, or death from any cause, whichever occurs first.

Proportion of patients without colostomy 12 months after Ch-RT termination.

Adverse events of grade 2 or higher by the Common Adverse Event Toxicity Criteria (CTCAE) version 4.0.

Incidence of positivity for HPV screening in tumor tissue through genotyping

Defined by variation in total number of lymphocytes, neutrophil / lymphocyte ratio (NLR) and lymphocyte / monocyte ratio (LMR)

Rachel Riechelmann

Head of Departament of Clinical Oncology

Eligible patients who consent to participate in this study will be randomized 1: 1 in two groups: Group A or experimental and Group B or control

The researchers will identify the patients through a unique number and through the initials of the name. Randomization will be simple and conducted independently by clinical trial support staff who are not participating in the study. The random sequence will be generated by computer program.

After an 8-10 hour overnight fast, Group A will receive two soft capsules of TPGS (400mg) emulsified berberine. Following a 7 day wash out period, Group A participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Following another 7 day wash out period, Group A participants will then receive two hard shell capsules of the berberine reference powder 400mg. Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group B will receive four soft capsules of Quillaja extract emulsified berberine (400mg). Following a 7 day wash out period, Group B participants will then receive two hard shell capsules of the berberine reference powder (400mg). Following another 7 day wash out period, Group B participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

After an 8-10 hour overnight fast, Group C will receive two hard shell capsules of the berberine reference powder (400mg). Following a 7 day wash out period, Group C participants will then receive two soft gel capsules of TPGS emulsified berberine (400mg). Following another 7 day wash out period, Group C participants will then receive four capsules of the Quillaja extract emulsified berberine (200mg). Each TPGS and berberine reference powder capsules contains 400 mg berberine. Each Quillaja extract capsule contains 200mg berberine. The total amount of berberine throughout is 800 mg.

Healthy

Two capsules of berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

Berberine

Two capsules of TPGS/Quillaja extract emulsified berberine. Each capsule contains 400 mg berberine. The total amount of berberine throughout is 800 mg.

TPGS emulsified berberine

Four capsules of Quillaja extract emulsified berberine. Each capsule contains 200 mg berberine. The total amount of berberine throughout is 800 mg.

Quillaja extract emulsified berberine

Food Science and human nutrition department at University of Florida

The Absorption of Bioactive Berberine in Human

To Test the Efficacy of Novel Berberine Emulsification by TPGS or Quillaja Extract on the Absorption of Berberine Compared to Berberine Powder in Humans

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing the area under the concentration-time curve (AUC).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its plasma concentration peak concentration (Cmax).

To determine change in bioavailability of orally ingested berberine in human volunteers by increasing its the time point of maximum plasma concentration (Tmax).

To determine change in berberine metabolites concentrations.

University of Florida

Florida High Tech Corridor Council

Designs for Health, Inc.

Neoplasm

Diarrhea

See Detailed description section for treatment details.

Irinotecan, Cefpodoxime

St. Jude Children's Research Hospital

Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors

Phase I Study of Intravenous Irinotecan Using Selective Gastrointestinal Decontamination for Prevention of Diarrhea in Relapsed or Refractory Pediatric Solid Tumors

beta glucuronidase/caureja

The Efficacy of Oral Probiotics on Neonatal Hyperbilirubinemia

Prebiotics and Probiotics During Definitive Treatment With Chemotherapy-radiotherapy SCC of the Anal Canal (BISQUIT)

The Absorption of Bioactive Berberine in Human

Prevention of Diarrhea in Patients Taking IV Irinotecan for Relapsed or Difficult to Treat Pediatric Solid Tumors

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