NCT06639425

Efficacy of Lactobacillus Paracasei LC19 on Type 2 Diabetes

Efficacy of Lactobacillus Paracasei LC19 on Newly Diagnosed Type 2 Diabetes

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Beijing Chao Yang Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized, double-blind, placebo-controlled clinical trial. The objective of this trial is to determine whether Lactobacillus paracasei LC19 supplementation has a positive effect on glucose lowering in patients with type 2 diabetes (T2D).

Detailed description

In this trial, approximately 60 drug-naive patients with newly diagnosed Type 2 Diabetes (T2D) will be recruited. Laboratory evaluations will be conducted on the subjects to confirm their eligibility before randomization. After the screening, eligible subjects will be randomly assigned in a 1:1 ratio to either the Lactobacillus paracasei LC19 supplementation group or the placebo group during the randomization visit. They will then enter a 12-week double-blind treatment period.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lactobacillus paracasei LC19 supplementation	Orally administered Lactobacillus paracasei LC19 strain product, in addition to lifestyle intervention. This product is a probiotic milk powder, and the Lactobacillus paracasei LC19 strain is capable of producing high levels of tryptophan-conjugated cholic acid (Trp-CA)( 25g/packet, 2 packets/day).
DIETARY_SUPPLEMENT	Placebo probiotic milk powder	Orally administered placebo probiotic milk powder, in addition to lifestyle intervention. The placebo probiotic strain also belongs to Lactobacillus paracasei species, but does not produce Trp-CA. These products have the same color, odor, appearance, and packaging (25g/packet, 2 packets/day).

Timeline

• Start date: 2024-10-12
• Primary completion: 2026-10-14
• Completion: 2026-12-31
• First posted: 2024-10-15
• Last updated: 2025-02-07

Locations

1 site across 1 country: China