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Evaluation of clinical intervention effect of probiotics in patients with metabolic diseases

Evaluation of clinical intervention effect of probiotics in patients with metabolic diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1800017868
Enrollment
Unknown
Registered
2018-08-18
Start date
2018-08-20
Completion date
Unknown
Last updated
2018-08-20

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

Conditions

metabolic diseases

Interventions

Experimental group of T2D:oral formula probiotics
Control group of T2D:oral placebo
Experimental group of hyperuricemia:oral formula probiotics
Control group of hyperuricemia:oral placebo

Sponsors

The Affiliated Sir Run Run Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 75 Years

Inclusion criteria

Inclusion criteria: This study recruit 120 patients with newly diagnosed type 2 diabetes and 120 patients with hyperuricemia in China within 3 years. The course of diseases are less than 1 year and the patients aged between 8 and 75 years old.

Exclusion criteria

Exclusion criteria: 1. Systemic application of glucocorticoids, other immunosuppressive drugs or biological immunomodulators, antibiotics, probiotics and other microecological preparations within 6 months prior to enrollment; 2. Active infection (including human immunodeficiency virus (HIV), hepatitis B and hepatitis C virus infection or tuberculin test positive); 3. combined with irritable bowel syndrome, inflammatory bowel disease, celiac disease and other chronic gastrointestinal diseases, the condition failed to control; 4. Chronic systemic autoimmune disease gastrointestinal involvement; 5. High risk of gastrointestinal cancer or polyposis; 6. recent diarrhea, blood in the stool; 7. Pregnant and lactating women, as well as women and men who participate in research and observation period are reluctant to adopt reliable contraceptive methods; 8. suffering from mental diseases or unwilling to accept intestinal microflora treatment; 9. The course of diseases are more than 1 year.

Design outcomes

Primary

MeasureTime frame
BMI;blood lipid;blood uric acid;FBG;PBG;HbA1c;

Secondary

MeasureTime frame
liver function;insulin;C-peptide;

Countries

China

Contacts

Public ContactLiu Yu

The Affiliated Sir Run Run Hospital of Nanjing Medical University

drliuyu@njmu.edu.cn+86 18751896699

Outcome results

None listed

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