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Evaluation of the clinical effect of Lactobacillus fermentum CCFM1126 on osteoporosis

Evaluation of the clinical effect of Lactobacillus fermentum CCFM1126 on osteoporosis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300076115
Enrollment
Unknown
Registered
2023-09-25
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

osteoporosis

Interventions

Probiotics group:Lactobacillus fermentans

Sponsors

Affiliated Hospital of Jiangnan University, Wuxi City, Jiangsu Province
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
50 Years to 75 Years

Inclusion criteria

Inclusion criteria: ? By bone mineral density CT and serum bone-related biochemical indicators (such as bone alkaline phosphatase, tartrate-resistant acid phosphatase, parathyroid hormone, etc.) examination, clinical diagnosis of osteopenia or osteoporosis patients; ? Postmenopausal women over 50 years old; ? The patient has no severe disease (such as a malignant tumor) or history of upper gastrointestinal tract (such as bradycardia); ? No secondary or idiopathic osteoporosis, no major illness or long-term medication history, and do not take any hormones, osteoporosis, or other drugs that will interfere with bone health during the study; ? Promise to cooperate with the research throughout the experiment, and be willing to provide written informed consent and basic information questionnaires ? For infectious diseases that do not need to be treated with antibiotics, antibiotics have not been used for nearly 1 month (except for local drugs), and probiotic drugs or foods containing probiotics have not been used for nearly 1 month (such as probiotic yogurt, pickles, etc.).

Exclusion criteria

Exclusion criteria: ? A history of gastrointestinal surgery (except appendectomy); ? Has secondary and idiopathic osteoporosis; ? Have a history of any serious disease (serious cardiovascular, endocrine, liver and kidney dysfunction, etc.); ? Patients were also excluded if they had taken antibiotics or probiotic products in the month prior to study inclusion; ? Participants in other clinical trials; ? Unwilling or unable to provide written informed consent to participate in the study after the researcher has notified the researcher of the purpose, process, and possible risks; ? Does not meet the requirements of the study or the researchers think that they should not participate in the study.

Design outcomes

Primary

MeasureTime frame
Bone mineral density;Serum 25 hydroxyvitamin D;Intestinal flora;

Secondary

MeasureTime frame
Serum biochemistry;Intestinal metabolites;

Countries

Chian

Contacts

Public ContactQixiao Zhai

School of Food Science, Jiangnan University

zhaiqixiao@jiangnan.edu.cn+86 159 6176 0920

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026