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IRCT20180527039866N1 IRCT 2018-08-02 Mashhad University of Medical Sciences The effect of probiotics in the treatment of prediabetic Effect of probiotic on control of glucose and lipid index in pre-diabetic patients 2018-07-23 anticipated 70 Complete https://irct.ir/trial/31525 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into two groups, one group being treated with probiotic pills and another group being treated with placebo. The method of randomization is that two cards are prepared and numerical coding 1 and 2 are recorded on it. Group 1 is related to probiotics and group 2 to placebo. Each patient is drawn with one of the cards without inserting the cards. We provide the conditions that both the patient and the doctor are unaware of the type of card and the treatment received, and blindness will occur, Blinding description: All participants in the study are unaware of the use of placebo or probiotics. They are grouped into a group based on the drawing of the card and provided with explanations that they may be in groups 1 and 2. The program Food, exercise, and how to use medication or placebo for everyone is the same. Care provider does not know that each participant is in which groups. Randomization is done by another one, outside the clinic room. The investigator or outcome assessor is also unaware of the status of the participants. Participants are referred to care provider after the randomization, and the questionnaire and the necessary explanations for the plan are given to them. Data analyser also does not contact the participants and does not know which group 1 and 2 are taking placebo or medication. 3 Prediabetes. Intervention 1: Intervention group: Pre-diabetes patients with a standard definition, are treated with probiotic capsule is given at a rate of more than 109 CFUs equivalent to 500 mg of capsules, daily. The lactacactor contains lactate and lactobacillus acidophilus. Intervention 2: Control group: Pre-diabetes patients with a standard definition are are treated with placebo daily. Yes - There is a plan to make this available What will be shared: Information on the main consequence of participants' data after being unidentifiable is shared If authorized by Mashhad University of Medical Sciences. When: Six months after printing results To whom: Researchers working in scientific institutions Conditions: If the type of analysis is relevant to general health. Where to obtain: By email address:MDS resaerch@mums.ac.ir How to obtain: Contact with the vice chancellor for research at Mashhad University of Medical Sciences by email mentioned the above. If the university agrees, the information will be sent by email. Comments:
public Somayeh sadat Shariatmaghani
No 9,Rahnamaii Ave 13,Rahnamaii street.,Mashhad
Mashhad Iran (Islamic Republic of) 1475815944 +98 51 3845 8779 shariatmaghanis@mums.ac.ir Mashhad University of Medical Sciences scientific Somayeh sadat Shariatmaghani
No 9,Rahnamaii Ave 13,Rahnamaii street.,Mashhad
Mashhad Iran (Islamic Republic of) 1475815944 +98 51 3845 8779 shariatmaghanis@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) All pre diabetic patients 30 to 65 years old 30 years 65 years Both Patients with previous diagnosis of diabetes Pre-diabetic patients that are under medical treatment GFR<60 A history of known digestive malformations or chronic diarrhea Receive probiotics, antibiotics, aspirin or B vitamins during the last three months R73.0 Abnormal glucose tolerance test Treatment - Drugs Placebo Intervention group: Pre-diabetes patients with a standard definition, are treated with probiotic capsule is given at a rate of more than 109 CFUs equivalent to 500 mg of capsules, daily. The lactacactor contains lactate and lactobacillus acidophilus. Control group: Pre-diabetes patients with a standard definition are are treated with placebo daily. Fasting Blood sugar. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Blood sampling. HbA1c. Timepoint: Before the intervention and three months after the intervention began. Method of measurement: Blood sampling. Mashhad University of Medical Sciences Approved 2017-11-01 Ethics committee of Mashhad Univercity of Medical Science Daneshgah Street.,in front of 18 Ave.,Mashhad Univercity of Medical Science Mashhad Razavi Khorasan Iran (Islamic Republic of)