Effects of Probiotics on diarrhea

Intervention 1: group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night). Intervention 2: group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening. Intervention 3: group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening.;Treatment - Drugs;Treatment - Drugs;Treatment - Drugs;group two take a combination of probiotic and honey (two probiotic capsules and 30 grams honey per day, one capsule and 15 grams honey in the morning after breakfast and another one capsule in the evening, and 15 grams honey at night);group three are the control group receive two placebo capsules (containing 500 mg of corn starch) per day, one capsule in the morning after breakfast and another one in the evening;group one take probiotics )contained: Lactobacillus casei 1.5 × 109 CFU, Lactobacillus acidophilus 1.5 × 1010 CFU, Lactobacillus rhamnosus 3.5 × 109 CFU, Lactobacillus bulgaricus 2.5 × 108 CFU, Bifidobacterium breve 1 × 1010 CFU, Bifidobacterium longum 5 × 108 CFU and Streptococcus thermophilus 1.5 × 108 CFU per 500 mg(; two probiotic capsules per day, one capsule in the morning after breakfast and another one in the evening
Primary outcome(s): Diarrhea grade. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Common Toxicity Criteria system.;Stool consistency score. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Bristol scales.;Blood cell counts. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: cell counter machine.;Serum IgA level. Timepoint: Weekly from one week before radiotherapy until end of treatment. Method of measurement: Autoanalyzer machine.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment.

干预方案1：第2组接受益生菌联合蜂蜜干预：每日服用2粒益生菌胶囊与30克蜂蜜，具体用法为早餐后晨起服用1粒胶囊搭配15克蜂蜜，晚间再服用1粒胶囊，并于睡前追加15克蜂蜜。
干预方案2：第3组为对照组，每日服用2粒安慰剂胶囊（每粒含500mg玉米淀粉），早餐后晨起服用1粒，晚间再服用1粒。
干预方案3：第1组仅服用益生菌制剂，每500mg胶囊所含活菌菌株及数量如下：干酪乳杆菌（Lactobacillus casei）1.5×10⁹ CFU、嗜酸乳杆菌（Lactobacillus acidophilus）1.5×10¹⁰ CFU、鼠李糖乳杆菌（Lactobacillus rhamnosus）3.5×10⁹ CFU、保加利亚乳杆菌（Lactobacillus bulgaricus）2.5×10⁸ CFU、短双歧杆菌（Bifidobacterium breve）1×10¹⁰ CFU、长双歧杆菌（Bifidobacterium longum）5×10⁸ CFU及嗜热链球菌（Streptococcus thermophilus）1.5×10⁸ CFU；每日服用2粒益生菌胶囊，早餐后晨起服用1粒，晚间再服用1粒。
主要结局指标：
1. 腹泻等级：观察时点为放疗前1周至治疗结束，每周评估1次，评估方法为通用毒性标准（Common Toxicity Criteria）系统。
2. 粪便性状评分：观察时点为放疗前1周至治疗结束，每周评估1次，评估方法为布里斯托尔粪便分型量表（Bristol scales）。
3. 血细胞计数：观察时点为放疗前1周至治疗结束，每周评估1次，评估方法为血细胞计数仪检测。
4. 血清免疫球蛋白A（IgA）水平：观察时点为放疗前1周至治疗结束，每周评估1次，评估方法为全自动生化分析仪（Autoanalyzer machine）检测。
研究设计：采用随机分组方式，未设盲法，使用安慰剂对照，分组类型为平行对照，研究目的为治疗性研究。