Probiotic yogurt on chemotherapy-induced diarrhea
Ontology highlight
ABSTRACT:
DISEASE(S): Diarrhea, Unspecified,Chemotherapy-induced Diarrhea
PROVIDER: 2475794 | ecrin-mdr-crc |
REPOSITORIES: ECRIN MDR
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Project description: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.
| 2485704 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group A: 20 patients randomly selected and placed in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site were resected then anastomosed. Intervention 2: Intervention group B : 20 patients randomly selected and placed in the anterior repair group. Anterior intestinal defect within the ileostomy site was repaired.
Primary outcome(s): The first day of defecation. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of flatus. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of oral feeding. Timepoint: daily up to one week. Method of measurement: stariting of oral diet based on surgeons decision.;Post operation early complications. Timepoint: daily up to one month. Method of measurement: question from the patient in daily ward visits.;Post operation late complications. Timepoint: monthly up to 6 months. Method of measurement: question from the patient in monthly clinic visits.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly assigned into two groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com, Blinding description: In this double-blind study, participants, collectors of results and analyzers, were blind to the study.
| 2492823 | ecrin-mdr-crc
Project description:Interventions: .;Lifestyle
Primary outcome(s): Body image nurturance. Timepoint: first admission,Dispensing from the hospital, after tow week followup. Method of measurement: Standard questionnaire.;Basic need satisfaction. Timepoint: first admission,Dispensing from the hospital, after tow week followup. Method of measurement: Standard questionnaire.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive, Other design features: By using random number patient divided in two group .( control and intervention).
| 2493809 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: The intervention is Polypill V, which includes aspirin (81 mg), valsartan (40 mg), atrostatin (20 mg) and hydrochlorothiazide (5.12 mg). This pill is produced Alborzl Company and is taken once a day after dinner. Intervention 2: Control group: patients are followed for cardiovascular events.
Primary outcome(s): Systolic and diastolic heart failure. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Symptomatic arrhythmia. Timepoint: 6 months and one year after the intervention. Method of measurement: Clinical symptoms, Ecocardiography.;Acute coronary syndromes. Timepoint: 6 months and one year after the intervention. Method of measurement: Ecocardiography.;Stroke. Timepoint: 6 months and one year after the intervention. Method of measurement: Brain CT scan.;Cardiovascular mortality. Timepoint: 6 months and one year after the intervention. Method of measurement: Death certificate.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Prevention, Randomization description: Stratified randomization is used for random allocation ofpatients. In breast cancer patients have three stratum : 1- The group that take anthracycline alone (60%) in which 78 people take drug and 78 people take usual care, 2- The group that take anthracycline and bevacizumab (20%) In this group, 26 people take drug and 26 people take usual care. 3 - The group that does not take anthracycline (20%) In this group, 26 people take drug and 26 people take usual care. In colon cancer patients have two stratum : 1 - Group that take chemotherapy (80%) In this group, 72 people take drug and 72 usual care. 2- Group that only undergoes surgery (20%) In this group, 18 people take drug and 18 people take usual care. Randomization is done using randomization software, the output of the software is from number 1 to 440, which indicates that each person who
| 2503026 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group receives mindfulness-based stress reduction(MBSR). This is an eight-week group training program, Whit a meeting held every week for two hours, in which patients experientially practice body scan, sitting media, mindful walking, hatta yoga, mindful eating. Intervention 2: Control group doesn’t receive any intervention. The group to the questionnaires in Pre test and post test.
Primary outcome(s): Cancer related fatigue. Timepoint: Pre test and post test. Method of measurement: Fatigue questionnaire.;Cancer related cognitive impairment. Timepoint: Pre and post test. Method of measurement: Wechsler memory scale-Revised.;Fear of cancer recurrence. Timepoint: Pre and post test. Method of measurement: Fear of cancer recurrence inventory.;Self management strategies. Timepoint: Pre and post test. Method of measurement: Smart.
Study Design: Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: One methods of randomization in studies is random blocking, in this way, the number of people assigned to each group is usually approximately the same. In this method, blocks are formed based on the desired variables, and within each block, half of the intervention and half as the control are considered.The main object of this method is to balance the number of participants in each group.
| 2496134 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: 1-Patients will take two capsules (daily) containing several probiotic strains from one week before the start of treatment until 10 days after the end of radiotherapy. Intervention 2: Intervention group: 2-Patients will take two capsules (daily) containing several probiotic strains from one week after the start of treatment to 10 days after the end of radiotherapy. Intervention 3: Control group: Two placebo capsules daily for ten days after the end of radiotherapy.
Primary outcome(s): Quality of life. Timepoint: At the beginning of the study and 8 weeks after the intervention. Method of measurement: Questionnaire.;Gastrointestinal disorders. Timepoint: At the beginning of the study and 6 months after the intervention. Method of measurement: Clinical examination by an oncologist.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Other design features: Participants will take probiotics for up to ten days after completing radiotherapy, Randomization description: Participants are randomly assigned to three groups to receive probiotics one week before the start of radiotherapy (n = 20), one week after the start of radiotherapy (n = 20) or placebo (n = 20), Blinding description: Randomization will be hidden from researchers and participants until the statistical analysis is completed.Another person who has no role in this clinical trial and is not aware of random allocation gives the capsules to participants.
| 2504274 | ecrin-mdr-crc
Project description:Intervention 1: Group A: In the intervention group, patients will receive lactocare capsules 500mg (zist takhmir pharmaceutical company) 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours. Intervention 2: Group B: In the control group, patients will receive placebo capsules 7 days before surgery and as soon as they start oral administration after surgery until their discharge or for a maximum of one week. The drug will be prescribed twice a day after meals and oral or intravenous antibiotics should not be taken for at least 2 hours.
Primary outcome(s): Postoperative ileus. Timepoint: From the day of operation to the day of discharge. Method of measurement: The first gas passing after surgery by day.;Number of days of hospitalization after surgery. Timepoint: From the day of operation to the day of discharge. Method of measurement: By day.;Time to start oral feeding. Timepoint: From the day of operation to the day of discharge. Method of measurement: The patient’s first day of oral feeding after surgery.;Postoperative infection / Abdominal abscess / Wound infection. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Postoperative pneumonia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and chest radiography at the discretion of the physician.;Anastomosis leak. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Heart failure / Kidney failure / Liver disfunction. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request laboratory tests if there are clinical signs.;Nausea and vomiting. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints.;Pain and dyspepsia. Timepoint: From the day of operation to the day of discharge. Method of measurement: Clinical examination and patient complaints.;Fever. Timepoint: From the day of operation to the day of discharge. Method of measurement: Physical examination.;Mortality in 30 days after surgery. Timepoint: From the day of surgery to 30 days after surgery. Method of measurement: Death report by physician.;SIRS. Timepoint: From the day of operation to the day of discharge. Method of measurement: Request tests if there are clinical signs.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person resp
| 2727544 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: performing 6 week chemotherapy with mFOLFOX 6 or CapeOx and then carry out surgery and continue chemotherapy for 18 weeks. Intervention 2: Control group: Initial surgery followed by chemotherapy with mFOLFOX 6 or CapeOx for 24 weeks.
Primary outcome(s): Disease Free Survival. Timepoint: One year after intervention. Method of measurement: No relapse of cancer.;Histological response and down staging of tumor. Timepoint: After surgery. Method of measurement: Pathological and radiological examination.
Study Design: Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization on individuals was performed using a table of random numbers. Allocation concealment was carried out, Blinding description: The surgeon, pathologist and radiologist are unaware of allocated groups. Besides, the outcome assessor who evaluates the quality of life is unaware of the allocated groups. The data analyser will be blinded to the intervention groups.
| 2481605 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group A: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then hand sewn anastomosis will be done. Intervention 2: Intervention group B : 32 patients randomly select and place in the anterior repair group. Anterior intestinal defect within the ileostomy site will be repaired. Intervention 3: Intervention group C: 32 patients randomly select and place in the resection and anastomosis group. Proximal and distal of the intestine within the ileostomy site are resected then anastomosis will be done by the stapler.
Primary outcome(s): The first day of defecation. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of flatus. Timepoint: daily up to one week. Method of measurement: question from the patient in daily ward visits.;The first day of oral feeding. Timepoint: daily up to one week. Method of measurement: stariting of oral diet based on surgeons decision.;Post operation early complications. Timepoint: daily up to one month. Method of measurement: question from the patient in daily ward visits.;Post operation late complications. Timepoint: monthly up to 6 months. Method of measurement: question from the patient in monthly clinic visits.
Study Design: Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomly assigned into three groups using randomly permuted blocks method. random allocation sequence was generated by the online platform www.randomization.com, Blinding description: In this double-blind study, participants, Investigator and Outcome assessor , were blind to the study.Before the surgery, the patients are randomly divided into three groups, which the patients and investigators do not know about it, and then the surgeon in the operating room is informed about the type of surgery of each patient, and the surgery is performed, and then the patients are transferred to the surgery ward. The patients are visited by the another surgeon ( investigator and outcome assessor) who is blind with the type of surgery of each patient and the information and data of the patients are collected and then the information is se
| 23569 | ecrin-mdr-crc
Project description:Intervention 1: Intervention group: The intervention group is subjected to peer support interventions for one month, at least twice a week by phone, and at least weekly by the Internet (virtual network) at least once a week. Intervention 2: The control group receives the same routine care and there is no intervention in it.
Primary outcome(s): Subjective well-being Score, in the Warwick Edinburgh Questionnaire. Timepoint: Before the intervention and one month after the end of the intervention. Method of measurement: Warwick Edinburgh subjective well-being Questionnaire.
Study Design: Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients are randomly assigned to two groups of intervention and control (using the random numbers table at www.randomization.com), Blinding description: The analyst will be unaware of the intervention and control groups and the data collected and which group it relates to.
| 2498403 | ecrin-mdr-crc