bone mass reduction
Conditions
Interventions
Experimental group:probiotics combined with vitamin D and calcium tablet
Control group:Placebo combined with vitamin D and calcium tablet
Sponsors
The First People's Hospital of Kunshan
Eligibility
Sex/Gender
Female
Age
50 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged from 50 to 70 years; 2. Menopause (defined as > 1 year since last menstrual period); 3. Body mass index (BMI) must be = 18 and = 32 kg/m2 at screening; 4. Bone mineral density (BMD) expressed by T value, >-2.5, <-1.0 in the lumbar spine (L1-L4), femoral neck or total hip, measured by DECA; 5. Promise not to use any products that may affect the results of the study; 6. Have lived in the local area for at least one year and have a fixed residence; 7. Have not participated in other drug clinical trials within 3 months before the trial; 8. Good compliance, eager to change their physical condition; 9. Sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Premenopausal state; 2. History of > 1 non-traumatic fractures; 3. Presence of established osteoporosis (T-score =-2.5 for lumbar, femoral neck or total hip measured by screening DECA); 4. History of immune or bone-related diseases, including: HIV infection, type I diabetes, bone marrow or organ transplantation; inflammatory bowel disease (ulcerative colitis, Crohn's disease); Multiple myeloma; Osteomalacia; Osteosarcoma; Rheumatoid arthritis; Systemic lupus erythematosus; Thyroid disease; 5. Uncontrolled type II diabetes (HgbA1c =7%) within the past 12 months; 6. History of bariatric surgery or other forms of malabsorption (including documented celiac disease or chronic diarrhea); 7. Have serious chronic diseases (coronary heart disease, immune deficiency, mental abnormalities, tumors, liver and kidney insufficiency, etc.) and complications; 8. Current (within the past 8 weeks) use of any drug known to have effects on the immune or skeletal system (e.g., immunomodulatory therapy, systemic corticosteroids, systemic steroid hormones); 9. Use of oral or injectable bisphosphonates for more than 1 year within the past 5 years; 10. Current or past (within 1 year) use of denosumab, teriparatide, raloxifene, hormone replacement therapy (HRT), calcitonin, or any other anti-resorbent other than bisphosphonates for the prevention and treatment of osteopenia; 11. Smoking or using nicotine-containing products within the past six months; 12. Uncontrolled thyroid disease (abnormal levels of blood thyroid-stimulating hormone (TSH) in the past 12 months and / or changes in the dose of thyroid replacement therapy in the past 12 months); 13. Antibiotic use in the past month; 14. Continuous use of probiotics, prebiotics or synbiotics in the past 14 days; 15. Alcoholism (drinking more than 5 times a week, with an average of 2 taels of liquor or half a kilogram of rice wine or more than 5 bottles of beer each time).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone metabolism related indicators ( CTX, P1NP, OC );pain rating scale;Gut microbiota analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum inflammatory factors ( C-reactive protein,TNF, IL-6 );serum 25-OH vitamin D;GSRS; | — |
Countries
CHINA
Contacts
Public ContactLiu Lei
The First People's Hospital of Kunshan
Outcome results
None listed