The effect of synbiotic in painful diabetic neuropathy

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

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