Evaluating the Potential of Probiotic Supplementation Sleep Quality

Launched by CHI-CHANG HUANG · Jun 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether certain probiotic supplements can help improve sleep quality for people who have trouble sleeping, as well as those dealing with anxiety, depression, or stress. The researchers will look at two specific types of probiotics to see if they can make a difference in sleep. They are looking for 90 participants aged 20 to 60 who have some sleep difficulties, as indicated by their scores on sleep quality questionnaires. To join the study, participants should have a regular daily routine, meaning no night shifts, and not be using antibiotics or other medications that could interfere with sleep.

If you decide to take part in this study, you will be assigned to receive either the probiotic supplement or a placebo (a non-active treatment) for eight weeks. Throughout this time, the researchers will check your blood, urine, and saliva, and you will fill out questionnaires about your sleep and overall well-being. It's important to know that certain health conditions and medications may disqualify you from participating, so please review the eligibility criteria carefully. This trial is currently recruiting, so if you're interested, it's a great opportunity to contribute to research that may help improve sleep for many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age 20 to 60 years old
• • Pittsburgh Sleep Quality Scale score is greater than or equal to 5
• • Insomnia Severity Scale (ISI less than 22 points)
• • Subjects need to have a regular daily routine (no night shift work)
• Exclusion Criteria:
• • Have used antibiotics or probiotic products in powder, capsule or tablet form within one month
• • Are taking drugs that may affect sleep (for example: sleeping pills, antipsychotic drugs, corticosteroids, antihistamines, stimulants, etc.) or undergoing hormonal treatment (including birth control pills)
• • Those who are taking traditional Chinese medicine or western medicine to treat serious acute diseases
• • Patients with uncontrolled high blood pressure or diabetes, a history of cancer, and mental illness
• • Those with a diagnosis of other sleep disorders besides insomnia (narcolepsy, restless legs, sleep apnea, etc.)
• • People who are allergic to probiotic products
• • Pregnant or breastfeeding
• • Alcohol, tobacco and coffee addicts
• • Have carried out long-distance travel or work across time zones in the past month and the next two months
• • Those who have participated in other interventional clinical studies in the past three months
• • Those who are judged by the moderator to be unsuitable to participate in the research