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IRCT20211226053534N1 IRCT 2022-02-19 Islamic Azad University Evaluation the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer Evaluation the effect of probiotics on gastrointestinal symptoms in patients with gastric cancer 2022-02-20 anticipated 60 Complete https://irct.ir/trial/60945 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this way, the allocation of samples to test or control groups will be done by random allocation (using blocking). The use of blocking will be done on different days due to the allocation of samples. In this method, the groups are first identified by giving the code to the groups that will be group A: intervention and B: control. 5 blocks of 6 are specified: 1- AABBAB, 2- BBAABA, 3-AABABB, 4-BABABA, 5-BBBAAA, 6- AAABBB. Finally, they are included in the study and placed in the intervention and control groups, respectively. After completing the first 5 blocks, the second block will be sampled, Blinding description: Participants will not be informed about which group they will be in. 2-3 Gasteric cancer. Intervention 1: Intervention group: Probiotic capsule containing three strains of probiotic bacteria including Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium longum and is one the products of Gostaresh Milad Pharmed Company will be provided to them and it is recommended that they take one capsule a day in the first two weeks. Intervention 2: Control group: participants will receive capsules containing maltodextrin prepared in both color and shape of the product capsules. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no more information
public Elham Mokhtari Amirmajdi
School of Medicine,Imam khomeini14 Aven, Mashhad
Mashhad Iran (Islamic Republic of) 9178673799 +98 915 316 5096 Emokhtaria@gmail.com Islamic Azad University scientific Elham Mokhtari Amirmajdi
School of Medicine,Imam khomeini14 Aven, Mashhad
Mashhad Iran (Islamic Republic of) 9178673799 +98 915 316 5096 Emokhtaria@gmail.com Islamic Azad University Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 18 to 70 years Endoscopically confirmed gastric cancer and pathology that are in the recovery phase (their treatment is over) Refer to the gastroenterology clinic of Azad University of mashhad educational hospitals Informed consent to enter the study 18 years 70 years Both Obvious neurological disease Probiotic consumption in the past month Dissatisfaction with inclusion in the study Lack of patient cooperation Lack of proper use of the Probiotic in both groups Sensitivity to the studied Probiotic Pregnant or lactating women Chronic users of non-steroidal anti-inflammatory drugs C16.9 Malignant neoplasm of stomach, unspecified Treatment - Drugs Placebo Intervention group: Probiotic capsule containing three strains of probiotic bacteria including Lactobacillus acidophilus, Bifidobacterium lactis and Bifidobacterium longum and is one the products of Gostaresh Milad Pharmed Company will be provided to them and it is recommended that they take one capsule a day in the first two weeks. Control group: participants will receive capsules containing maltodextrin prepared in both color and shape of the product capsules. VAS visual scale for Gastrointestinal symptoms such as abdominal pain, diarrhea, constipation and bloating. Timepoint: Before the intervention and at the end of the fourth and eighth weeks. Method of measurement: VAS visual scale. . Timepoint: . Method of measurement: . Islamic Azad University Approved 2021-06-23 Islamic Azad University - Mashhad Branch (Research Ethics Committee) Islamic Azad University School of Medicine,Imam khomeini14 Aven, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)