drugset / Trial / NCT06883760

Intervention Study on Probiotic Combination Tableted Candy Hangover

NCT06883760 ↗

Completed 40 enrolled Zhejiang University
RandomizedParallel-groupOpen-labelPrevention

Summary

Study Design Type: Randomized, blinded, placebo-controlled, crossover trial Participants: 40 volunteers, divided into two groups (n=20) Grouping Method: Minimization randomization based on age and BMI matching Intervention Sequence: Group A: Probiotic intervention → washout → placebo intervention Group B: Placebo intervention → washout → probiotic intervention Blinding: Participants, data collectors, and data analysts were blinded Roles: Randomization, data collection, and data analysis were performed by different researchers Intervention Process Phase 1 (Week 1): Group A: Took probiotic tablets (1g twice daily, 0.5g/tablet) Group B: Took placebo tablets (1g twice daily, 0.5g/tablet) Washout Period: 2 weeks Phase 2 (Week 4): Group A: Took placebo tablets Group B: Took probiotic tablets Sample Collection Fecal Samples: Collected at three time points: Baseline (1 week before alcohol test) Day 7 (after Phase 1) Day 28 (after Phase 2) Alcohol Tests: Conducted on Day 7 and Day 28 after overnight fasting Body Weight: Measured on test days; alcohol dosage adjusted accordingly (1 mL/kg, 40% v/v) Serum and Saliva: Collected at multiple time points post-alcohol consumption

Timeline

Start
2023-10-17
Primary completion
2023-12-23
Completion
2024-02-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Probiotic tablet candy Unknown 1 g —

Indications

No indication recorded.