Poor Quality SleepNCT06107049
the Effect of Probiotic on Sleep Quality Management
A study testing BLa80 in people with Poor Quality Sleep, run by Wecare Probiotics Co., Ltd. at 1 site in China.
Trial summary
The goal of this clinical trial is to learn about the improvement of sleep quality of probiotic BLa 80 in 110 healthy college students. The main question it aims to answer is whether probiotic BLa80 can effectively improve the sleep quality of college students. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Poor Quality Sleep
- What is being tested?
- BLa80
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2023to 30 Mar 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- PSQI Pittsburgh Sleep Quality Index score > 6 and < 18;
- ISI insomnia Severity Index score > 8 and < 23.
Who cannot join
- Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
- Mental or nervous system diseases, celiac disease, lactose intolerance, allergy;
- Have the following diseases: irritable bowel syndrome, diabetes, ulcerative colitis, etc.;
- Recent antibiotic treatment (i.e. < 3 months before study start);
- Participants who smoked more than 10 cigarettes per day were excluded;
- Other people with special circumstances are not recommended to participate, such as those who are allergic to probiotic products;
- Pregnant women, breastfeeding women and people under 19 years old and over 45 years old should not be tested.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Probiotics Improve Sleep Quality: a Randomized Placebo-controlled Trial
The goal of this clinical trial is to learn about the improvement of sleep quality of probiotic BLa 80 in 110 healthy college students. The main question it aims to answer is whether probiotic BLa80 can effectively improve the sleep quality of college students. The experiment commenced with participants continuously consuming the recommended amount of the probiotic powder for approximately 8 weeks. Simultaneously, they were required to fill out an "Effect Evaluation Form" every week and submit it to relevant department. At the end of the first and eighth weeks, participants underwent tests for five liver functions, four lipid profiles, blood sugar, and uric acid levels, as well as stool sample collection. They then completed the "Mid-Term Effect Evaluation Form".
Read the detailed description
Over the past few decades, the health benefits of probiotics have garnered extensive scientific attention. Particularly in the treatment of gastrointestinal and metabolic disorders, probiotics have shown potential therapeutic effects. The benefits of probiotics to the intestinal environment include improving intestinal barrier function, producing antimicrobial substances, competing with pathogenic bacteria, and regulating cavity acidity. However, research results on the benefits of probiotics for healthy adults are inconsistent. This may be due to variations in consumer sensitivity to the effects of probiotics and differences between probiotic products. The relationship between gut microbiota and human health has been widely recognized, especially in relation to diseases like obesity and diabetes. To verify the effects of the Bifidobacterium BLa80 product, a consumer test experiment was conducted, aiming to test and collect data on the changes in the gut microbiota of participants before and after using the product. The test plan lasted for 10 weeks, including a washout period at the beginning and end. During the experiment, participants consumed Bifidobacterium BLa80 and underwent multiple health checks and evaluations.
- Conditions
- Poor Quality Sleep
- Being tested
- BLa80
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLa80Dietary supplement
During the experiment, the subjects took a packet of probiotics every day, and the sleep condition, anxiety level and memory level of the subjects were evaluated by questionnaires and ability tests. The questionnaire included PSQI Pittsburgh Sleep Quality Index scale, ISI Insomnia Severity Index Scale and GSRS gastrointestinal symptom Score scale.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic group | Active comparator | Participants in the probiotic group received 3g of BLa80 product per day. Receives: Dietary Supplement: BLa80 |
| Placebo group | Placebo comparator | Participants in the placebo group received 3g of maltodextrin per day. Receives: Dietary Supplement: BLa80 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep quality
ISI insomnia Severity Index Scale questionnaire（It is divided into 7 items, with a total score of 28 points. 0 to 7 is divided into clinically insignificant insomnia, 8 to 14 is divided into mild insomnia, 15 to 21 is divided into moderate insomnia, and 22 to 28 is divided into severe insomnia.）
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2023
- Study start1 Nov 2023
- Primary completion30 Mar 2024
- Study completion30 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Poor Quality SleepStudies of the same condition, open and under way.
- More trials run by Wecare Probiotics Co., Ltd.The sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wecare Probiotics Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06107049
- Sponsor's protocol ID
- WK2023006
- Status last verified
- Apr 2024
- First submitted
- 24 Oct 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Improve Sleep Quality: a Randomized Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT06107049
- Acronym / sponsor ID
- WK2023006
- Conditions
- Poor Quality Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Wecare Probiotics Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Mar 2024 (actual)
- Study completion
- 30 Mar 2024 (actual)
- First posted
- 30 Oct 2023 (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.
The goal of this clinical trial is to learn about the improvement of sleep quality of probiotic BLa 80 in 110 healthy college students. The main question it aims to answer is whether probiotic BLa80 can effectively improve the sleep quality of college students. The experiment commenced with participants continuously consuming the recommended amount of the probiotic powder for approximately 8 weeks. Simultaneously, they were required to fill out an "Effect Evaluation Form" every week and submit it to relevant department. At the end of the first and eighth weeks, participants underwent tests for five liver functions, four lipid profiles, blood sugar, and uric acid levels, as well as stool sample collection. They then completed the "Mid-Term Effect Evaluation Form".
Detailed description
Over the past few decades, the health benefits of probiotics have garnered extensive scientific attention. Particularly in the treatment of gastrointestinal and metabolic disorders, probiotics have shown potential therapeutic effects. The benefits of probiotics to the intestinal environment include improving intestinal barrier function, producing antimicrobial substances, competing with pathogenic bacteria, and regulating cavity acidity. However, research results on the benefits of probiotics for healthy adults are inconsistent. This may be due to variations in consumer sensitivity to the effects of probiotics and differences between probiotic products. The relationship between gut microbiota and human health has been widely recognized, especially in relation to diseases like obesity and diabetes. To verify the effects of the Bifidobacterium BLa80 product, a consumer test experiment was conducted, aiming to test and collect data on the changes in the gut microbiota of participants before and after using the product. The test plan lasted for 10 weeks, including a washout period at the beginning and end. During the experiment, participants consumed Bifidobacterium BLa80 and underwent multiple health checks and evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic group | Active comparator | Dietary Supplement: BLa80Participants in the probiotic group received 3g of BLa80 product per day. |
| Placebo group | Placebo comparator | Dietary Supplement: BLa80Participants in the placebo group received 3g of maltodextrin per day. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- PSQI Pittsburgh Sleep Quality Index score > 6 and < 18;
- ISI insomnia Severity Index score > 8 and < 23.
Key exclusion criteria (7 listed)
- Those who have been diagnosed with diabetes or have high blood sugar are not recommended to participate in the test;
- Mental or nervous system diseases, celiac disease, lactose intolerance, allergy;
- Have the following diseases: irritable bowel syndrome, diabetes, ulcerative colitis, etc.;
- Recent antibiotic treatment (i.e. < 3 months before study start);
- Participants who smoked more than 10 cigarettes per day were excluded;
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 |
|---|---|---|
| BLa80During the experiment, the subjects took a packet of probiotics every day, and the sleep condition, anxiety level and memory level of the subjects were evaluated by questionnaires and ability tests. The questionnaire included PSQI Pittsburgh Sleep Quality Index scale, ISI Insomnia Severity Index Scale and GSRS gastrointestinal symptom Score scale. | Dietary supplement | Placebo group, Probiotic group |
Primary outcome
Changes in sleep quality
Time frame: 8 weeks
ISI insomnia Severity Index Scale questionnaire（It is divided into 7 items, with a total score of 28 points. 0 to 7 is divided into clinically insignificant insomnia, 8 to 14 is divided into mild insomnia, 15 to 21 is divided into moderate insomnia, and 22 to 28 is divided into severe insomnia.）
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 26 Apr 2024.
- Individual participant dataSharing planned: No
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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 BLa80 in people with Poor Quality Sleep, run by Wecare Probiotics Co., Ltd. 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 2 inclusion and 7 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 26 Apr 2024. 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 in sleep quality (time frame: 8 weeks). 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 26 Apr 2024.