CompletedNot Applicable

Intervention Study on Probiotic Combination Tableted Candy Hangover

China40 participantsStarted 2023-10-17

Plain-language 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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Age: 18-60 years old * BMI: 18-25 kg/m2 * Healthy adults with experience of being drunk, fully understanding the experimental plan, and voluntarily agreeing to participate * Able to tolerate a certain amount of alcohol (calculated as 60 kg, about 60 mL of 40-proof liquor) * Must be able to swallow tablets Exclusion Criteria: * People who are very intolerant to alcohol, with aldehyde dehydrogenase activity of 2% * People with a history of allergic reactions or clinical allergic reactions to drugs, alcohol, products or other ingredients * People who have taken drugs that induce and inhibit drug metabolizing enzymes, such as barbiturates, within one month from the date of the screening test * People who have taken drugs that affect the results of clinical trials (alcohol metabolism) (aspirin, antipyretics, anti-inflammatory drugs, analgesics, antibiotics, herbal medicines, oral steroids, hormones, etc.) within 1 month from the screening population * People who have taken drugs, products and functional foods that affect the intestines (such as probiotics, yogurt, etc.) within 10 days before the test * People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test * People who have taken drugs, products or functional foods that have a functional effect on the stomach and liver within 10 days before the test. Those who have taken products that affect the test results, such as p…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Changes from baseline blood alcohol during alcohol test at 1 month

Timeframe: Baseline (Day 0), Intervention end point (Day 28)

Trial details

NCT IDNCT06883760

SponsorZhejiang University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-12-23

View on ClinicalTrials.gov More Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking trials