the Effect of Probiotic on Sleep Quality Management

NCT06107049 | Completed

• 1 other identifier: WK2023006
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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. 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".

Conditions

Poor Quality Sleep

Outcome Measures

Primary Outcomes (1)

• 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.）

  8 weeks

Study Arms (2)

Probiotic group

ACTIVE COMPARATOR

Participants in the probiotic group received 3g of BLa80 product per day.

Dietary Supplement: BLa80

Placebo group

PLACEBO COMPARATOR

Participants in the placebo group received 3g of maltodextrin per day.

Dietary Supplement: BLa80

Interventions

BLa80 DIETARY_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.

Placebo group; Probiotic group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• PSQI Pittsburgh Sleep Quality Index score \> 6 and \< 18;
• ISI insomnia Severity Index score \> 8 and \< 23.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Technology

Zhengzhou, Henan, 450001, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2023
• First Posted: October 30, 2023
• Study Start: November 1, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)