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IRCT20090901002394N49 IRCT 2023-07-31 Iran University of Medical Sciences The effect of synbiotic in painful diabetic neuropathy The effect of synbiotic on quality of life, sleep interference, pain, and metabolic indices of patients with painful diabetic neuropathy 2023-07-28 anticipated 60 Complete https://irct.ir/trial/70360 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to randomize the samples, first, a list of 60 items is generated by computer random number generation using random allocation software version 1.0.0 that is publicly available, into two groups of 30 items labeled as A or B. This list is provided to the researcher. eligible participants are allocated to either group A or B. The manufacturer of the placebo is asked to put one of the labels A or B on the synbiotics and the other on the placebo by throwing a coin and keeping this confidential until the end of the data analysis. Therefore the synbiotics are indicated with one of the letters A or B, and the placebos by the other letter. According to the randomization table, the researcher will distribute the synbiotic and placebo according to the order of reference of the samples from packages A or B, Blinding description: This research is a triple-blind clinical trial study in which participants, researchers, and data analysts will not know the type of intervention (placebo and synbiotic) received by the participants during the study. blinding of the participants will be done by using indistinguishable synbiotic and placebo. participants in the placebo group will be provided with placeboes identical to those in synbiotic group that are identical in terms of color, scent, and taste but filled with Lactose monohydrate, talc, magnesium stearate, maltodextrin, Avicel, sodium starch, and aerosol. in order to blind the researcher and data analyst, The manufacturer of the placebo is asked to put one of the labels A or B on the drug and the other on the placebo by throwing a coin and keep this confidential until the end of the data analysis. 3 Painful diabetic neuropathy. Intervention 1: Intervention group: 30 patients with painful diabetic neuropathy receiving FamiLact synbiotic containing 10 to 9 CFU of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium lactis, Streptococcus thermophilus species as probiotics. and Fructooligosaccharides (FOS) as prebiotics, manufactured by ZIST TAKHMIR Company for 8 weeks. Intervention 2: Control group: 30 participants in the placebo group (capsules completely similar to the synbiotic group in terms of color, smell, and taste, but filled with lactose monohydrate, talc, magnesium stearate, maltodextrin, Avicel, sodium starch, and aerosol), manufactured by the ZIST TAKHMIR company for 8 weeks. Yes - There is a plan to make this available What will be shared: Information about primary and secondary outcomes will be available upon request from the researcher. When: The data will be available 6 months after the results are published. To whom: The data will be available to all researchers. Conditions: The data will be available for research purposes only. Where to obtain: Manoochehr Amin Amlashi: Email: ManoochehrAminAmlashi@gmail.com Shima Jazayeri: Email: sh_jazayeri@tums.ac.ir How to obtain: The request should be made via email to the researchers. The data will be available after the request is reviewed. Comments:
public Manoochehr Amin Amlashi
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 ManoochehrAminAmlashi@gmail.com Iran University of Medical Sciences scientific Shima Jazayeri
Iran University of Medical Sciences, Faculty of Health, Hemat Highway, next to Milad Tower, Tehran
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4805 sh_jazayeri@tums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosing diabetes based on the patient's record according to the doctor's diagnosis based on the criteria of the American Diabetes Association for at least one year before the start of the study. Diagnosing peripheral diabetic neuropathy based on the patient's record according to the doctor's diagnosis based on the criteria of the American Diabetes Association for at least three months before the start of the study (based on the results of small fiber function, including the feeling of temperature or pinprick, as well as the results of large-fiber function including vibration feeling using 128 Hz tuning fork and 10-g monofilament) Patients aged 35 to 70 years No pregnancy or breastfeeding Stable blood sugar control with an HbA1C level of less than 8% based on the patient's record stably receiving antidiabetic drugs without changing their type and dosage for 30 days before randomization NRS score of at least 4 out of ten averaged over 24 hours per day for at least one week before the start of the study No other chronic diseases such as kidney and liver failure, cancer, etc. Not taking supplements or receiving a special diet in the three months before the start of the study Willingness, contentment, and ability to carry out and complete the study and cooperate with the researcher 35 years 70 years Both People with immunodeficiency, short bowel syndrome (SBS), inflammatory bowel disease People with central venous catheters or heart valve disease People with hypothyroidism and other thyroid disorders People with non-diabetic neuropathies, including drug-induced neuropathy (such as isoniazid and chemotherapy), paraneoplastic neuropathy, spinal cord diseases such as intervertebral disc herniation People with pregnancy or expect to be pregnant during the study, as well as Breastfeeding Mother People receiving drugs or supplements or antibiotics not determined in the research People who, according to the researcher, have psychological, medical, and medicinal characteristics that put their mental and physical health at risk during the study (such as people with severe anxiety, severe depression, mania, dementia, history of drug and alcohol addiction) Inadequate education and/or ability to interview G63 Polyneuropathy in diseases classified elsewhere Treatment - Other Placebo Intervention group: 30 patients with painful diabetic neuropathy receiving FamiLact synbiotic containing 10 to 9 CFU of Lactobacillus rhamnosus, Lactobacillus casei, Lactobacillus acidophilus, Lactobacillus plantarum, Bifidobacterium breve, Bifidobacterium longum, Bifidobacterium bifidum, Bifidobacterium lactis, Streptococcus thermophilus species as probiotics. and Fructooligosaccharides (FOS) as prebiotics, manufactured by ZIST TAKHMIR Company for 8 weeks. Control group: 30 participants in the placebo group (capsules completely similar to the synbiotic group in terms of color, smell, and taste, but filled with lactose monohydrate, talc, magnesium stearate, maltodextrin, Avicel, sodium starch, and aerosol), manufactured by the ZIST TAKHMIR company for 8 weeks. Fasting blood sugar. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: laboratory test. INSULIN. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: laboratory test. HOMA-IR. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: calculation. Type and intensity of pain. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: short form McGill pain questionnaire-2 (SF-MPQ2). Pain intensity. Timepoint: Before intervention and at the end of each week until the end of the Eighth week. Method of measurement: numeric rating scale questionnaire. Insomnia Severity. Timepoint: 8 weeks. Method of measurement: Insomnia Severity index questionnaire. Sleep Interference Scale. Timepoint: Before intervention and at the end of each week until the end of the Eighth week. Method of measurement: Sleep Interference Scale questionnaire. Quality of life. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: SF-36 quality of life questionnaire. Weight. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: scale. Body mass index. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: calculation. Waist circumference. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: متر نواری. Systolic blood pressure. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: blood pressure monitor. Diastolic blood pressure. Timepoint: Before intervention and after 8 weeks of intervention. Method of measurement: blood pressure monitor. Iran University of Medical Sciences Approved 2023-05-23 Ethics committee, Iran University of Medical Sciences Iran University of Medical Sciences-near Milad Hospital-between the intersection of Sheikh Fazlollah Nouri and Shahid Chamran-Shahid Hemmat Highway tehran Tehran Iran (Islamic Republic of)