Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After DrinkingNCT06883760
Intervention Study on Probiotic Combination Tableted Candy Hangover
A study testing Probiotic tablet candy group in people with Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking and The Potential of the Probiotics Combination Tablet on Alcohol Metabolism, run by Zhejiang University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking, The Potential of the Probiotics Combination Tablet on Alcohol Metabolism
- What is being tested?
- Probiotic tablet candy group
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2023to 6 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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 products or drugs that relieve alcohol, etc.
- Those who suffer from severe acute or chronic diseases such as cardiovascular disease, metabolic disease, hepatobiliary disease, pancreatic disease, muscle disease, nervous system disease, mental disorder, endocrine disease, immune disease, kidney disease, malignant tumor, lung disease and other diseases that require treatment
- Those who have received or are receiving clinically significant treatment for gastrointestinal diseases such as gastric or duodenal ulcers
- Those who have donated blood within 2 months from the date of screening
- Those whose serum AST, ALT or creatine kinase levels are higher than the reference range or twice the serum upper limit, and the creatinine level in the diagnostic test exceeds 2.0 mg/dL
- Those who are considered unsuitable due to diagnostic test results or other reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intervention Study on Probiotic Composite Compressed Candy Tablets for Alleviation of Alcohol-Induced Symptoms
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:
Read more
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
Read the detailed description
A randomized, blinded, placebo-controlled, crossover trial was conducted. Forty participants were divided into two groups (n=20). Then, for each block, randomization was performed by minimization by matching age and body mass index (BMI). The two groups received different sequences of Probiotic combination intervention and maltodextrin intervention (placebo), coded as A and B to conceal their identities. Participants, data collectors, and data analysts were blinded throughout the study. Different researchers performed randomization, data collection, and data analysis.
The 40 volunteers recruited were randomly divided into two groups (n=20) after signing the informed consent form, namely the Probiotic combination intervention group (Group A, probiotic intake → flushing → placebo intake) and the maltodextrin (placebo) group (Group B, placebo intake → flushing → probiotic intake). Group A tried the compressed tablet product for 1 week, and Group B tried the placebo for 1 week; after a 2-week washout period, Group A tried the placebo for 1 week, and Group B tried the compressed tablet product for 1 week. During the intervention period, volunteers took 1g of the compressed tablets twice a day (0.5g/tablet, 2 tablets) in the morning, noon and evening, and during the intervention period, volunteers took 1g of the placebo twice a day (0.5g/tablet, 2 tablets) in the morning and evening. Feces of all volunteers were collected one week before the alcohol experiment (first time), and the second and third feces were collected on the 7th and 28th days, respectively. Alcohol tests were performed on the 7th and 28th days after an overnight fast. Body weight was measured on the test day, and liquor was provided according to body weight. Participants ate a meal (standard diet) containing alcohol (alcohol content: 40% v/v, 1 mL/kg body weight), and serum and saliva of volunteers were collected at different time points after the meal. During the intervention period, all subjects followed their original dietary habits and stopped taking other alcohol-detoxifying and liver-protecting drugs or drugs that may affect alcohol metabolism. The medication method during the alcohol test was: 2 pills before the alcohol tolerance test after lunch (the first time point); 2 pills before drinking (i.e., before the hangover test at two time points); and 2 pills after waking up.
- Conditions
- Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking, The Potential of the Probiotics Combination Tablet on Alcohol Metabolism
- Being tested
- Probiotic tablet candy group
- Keywords
- probiotics, medicine and food homologous substances, bioactive peptides, alcohol consumption
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic tablet candy groupCombination product
40 volunteers were randomly divided into two groups (n=20): Group A (probiotic → washout → placebo) and Group B (placebo → washout → probiotic). Each group took 1g of tablets (0.5g/tablet, 2 tablets) twice daily for 1 week, followed by a 2-week washout, then switched interventions. Fecal samples were collected at baseline, Day 7, and Day 28. Alcohol tests were conducted on Days 7 and 28 after fasting; participants consumed alcohol (1 mL/kg, 40% v/v) with a standard meal. Serum and saliva were collected post-meal. Body weight was measured, and alcohol dosage was adjusted accordingly. Participants maintained their usual diet and avoided alcohol-detoxifying or liver-protecting drugs. Medication during alcohol tests: 2 pills before tolerance test (after lunch), 2 pills before drinking, and 2 pills after waking.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Not described Receives: Combination Product: Probiotic tablet candy group |
| Probiotic tablet candy | Experimental | Not described Receives: Combination Product: Probiotic tablet candy group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes from baseline blood alcohol during alcohol test at 1 month
Determination of the change of blood alcohol of the participants during alcohol test at 1 months.
Measured: Baseline (Day 0), Intervention end point (Day 28)
Secondary outcomes (3)
Changes in serum acetaldehyde during alcohol test at 1 month
Determination of the changes of serum acetaldehyde during alcohol test at 1 month
Measured: Baseline (Day 0), Intervention end point (Day 28)
Changes of saliva acetaldehyde during alcohol test from baseline at 1 month
Determination of the changes of saliva acetaldehyde during alcohol test from baseline at 1 month
Measured: Baseline (Day 0), Intervention end point (Day 28)
Change from baseline fecal microbiota at 1 month
Determination of the change from baseline fecal microbiota at 1 month
Measured: Baseline (Day 0), Intervention end point (Day 28)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2025
- Study start17 Oct 2023
- Primary completion23 Dec 2023
- Study completion6 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After DrinkingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengqin Feng, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06883760
- Sponsor's protocol ID
- LL2023-X27
- Status last verified
- Mar 2025
- First submitted
- 6 Mar 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Privacy and Ethical Concerns: IPD often contains sensitive personal information, and sharing it may violate privacy protection regulations or the requirements of ethical review boards, especially if the data is not fully de-identified. Data Ownership and Control: The research team may retain ownership of the data and wish to maintain control over its use to ensure it is utilized in alignment with the original research objectives. Intellectual Property and Commercial Interests: Certain research may involve potential commercial value or intellectual property, and sharing IPD could impact future patent applications or commercialization efforts. Resource Constraints: Preparing and sharing IPD in a usable and compliant format can be time-consuming and resource-intensive, which may not be feasible for the research team. Risk of Misinterpretation: Shared data might be misinterpreted or misused by others, potentially leading to incorrect conclusions or misuse of the findings.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Study on Probiotic Composite Compressed Candy Tablets for Alleviation of Alcohol-Induced Symptoms
- ClinicalTrials.gov ID
- NCT06883760
- Acronym / sponsor ID
- LL2023-X27
- Conditions
- Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking, The Potential of the Probiotics Combination Tablet on Alcohol Metabolism
- Keywords
- probiotics, medicine and food homologous substances, bioactive peptides, alcohol consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Study start
- 17 Oct 2023 (actual)
- Primary completion
- 23 Dec 2023 (actual)
- Study completion
- 6 Feb 2024 (actual)
- First posted
- 19 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
A randomized, blinded, placebo-controlled, crossover trial was conducted. Forty participants were divided into two groups (n=20). Then, for each block, randomization was performed by minimization by matching age and body mass index (BMI). The two groups received different sequences of Probiotic combination intervention and maltodextrin intervention (placebo), coded as A and B to conceal their identities. Participants, data collectors, and data analysts were blinded throughout the study. Different researchers performed randomization, data collection, and data analysis.
The 40 volunteers recruited were randomly divided into two groups (n=20) after signing the informed consent form, namely the Probiotic combination intervention group (Group A, probiotic intake → flushing → placebo intake) and the maltodextrin (placebo) group (Group B, placebo intake → flushing → probiotic intake). Group A tried the compressed tablet product for 1 week, and Group B tried the placebo for 1 week; after a 2-week washout period, Group A tried the placebo for 1 week, and Group B tried the compressed tablet product for 1 week. During the intervention period, volunteers took 1g of the compressed tablets twice a day (0.5g/tablet, 2 tablets) in the morning, noon and evening, and during the intervention period, volunteers took 1g of the placebo twice a day (0.5g/tablet, 2 tablets) in the morning and evening. Feces of all volunteers were collected one week before the alcohol experiment (first time), and the second and third feces were collected on the 7th and 28th days, respectively. Alcohol tests were performed on the 7th and 28th days after an overnight fast. Body weight was measured on the test day, and liquor was provided according to body weight. Participants ate a meal (standard diet) containing alcohol (alcohol content: 40% v/v, 1 mL/kg body weight), and serum and saliva of volunteers were collected at different time points after the meal. During the intervention period, all subjects followed their original dietary habits and stopped taking other alcohol-detoxifying and liver-protecting drugs or drugs that may affect alcohol metabolism. The medication method during the alcohol test was: 2 pills before the alcohol tolerance test after lunch (the first time point); 2 pills before drinking (i.e., before the hangover test at two time points); and 2 pills after waking up.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Combination Product: Probiotic tablet candy group |
| Probiotic tablet candy | Experimental | Combination Product: Probiotic tablet candy group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic tablet candy group40 volunteers were randomly divided into two groups (n=20): Group A (probiotic → washout → placebo) and Group B (placebo → washout → probiotic). Each group took 1g of tablets (0.5g/tablet, 2 tablets) twice daily for 1 week, followed by a 2-week washout, then switched interventions. Fecal samples were collected at baseline, Day 7, and Day 28. Alcohol tests were conducted on Days 7 and 28 after fasting; participants consumed alcohol (1 mL/kg, 40% v/v) with a standard meal. Serum and saliva were collected post-meal. Body weight was measured, and alcohol dosage was adjusted accordingly. Participants maintained their usual diet and avoided alcohol-detoxifying or liver-protecting drugs. Medication during alcohol tests: 2 pills before tolerance test (after lunch), 2 pills before drinking, and 2 pills after waking. | Combination product | Placebo, Probiotic tablet candy |
Primary outcome
Changes from baseline blood alcohol during alcohol test at 1 month
Time frame: Baseline (Day 0), Intervention end point (Day 28)
Determination of the change of blood alcohol of the participants during alcohol test at 1 months.
3 secondary outcomes
Changes in serum acetaldehyde during alcohol test at 1 month
Time frame: Baseline (Day 0), Intervention end point (Day 28)
Changes of saliva acetaldehyde during alcohol test from baseline at 1 month
Time frame: Baseline (Day 0), Intervention end point (Day 28)
Change from baseline fecal microbiota at 1 month
Time frame: Baseline (Day 0), Intervention end point (Day 28)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No. Privacy and Ethical Concerns: IPD often contains sensitive personal information, and sharing it may violate privacy protection regulations or the requirements of ethical review boards, especially if the data is not fully de-identified. Data Ownership and Control: The research team may retain ownership of the data and wish to maintain control over its use to ensure it is utilized in alignment with the original research objectives. Intellectual Property and Commercial Interests: Certain research may involve potential commercial value or intellectual property, and sharing IPD could impact future patent applications or commercialization efforts. Resource Constraints: Preparing and sharing IPD in a usable and compliant format can be time-consuming and resource-intensive, which may not be feasible for the research team. Risk of Misinterpretation: Shared data might be misinterpreted or misused by others, potentially leading to incorrect conclusions or misuse of the findings.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic tablet candy group in people with Probiotic Combination Have the Potential to Improve Alcohol and Acetaldehyde in the Body After Drinking and The Potential of the Probiotics Combination Tablet on Alcohol Metabolism, run by Zhejiang University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes from baseline blood alcohol during alcohol test at 1 month (time frame: Baseline (Day 0), Intervention end point (Day 28)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2025.