Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:44 PM
Ignite Modification Date:
2025-12-24 @ 5:44 PM
NCT ID:
NCT06361368
Eligibility Criteria:
Inclusion Criteria:
1. aged 20-60 years old,
2. self-reported Insomnia (PSQI ≥ 7 \& 22 \> ISI ≥ 12),
3. 17.5 \< BMI \< 35 kg/m\^2, and
4. regular sleep cycle.
Exclusion Criteria:
1. used antibiotic, sleep aids, tranquilizers, or antipsychotic treatment within the last month,
2. used other probiotic products within the last month,
3. taking medications known to commonly induce sleep disorders (such as corticosteroids, antihistamines, and stimulants, etc.) or currently undergoing hormone therapy, including contraceptive pills,
4. have undergone hepatobiliary gastrointestinal tract surgery
5. lactic acid bacteria allergy,
6. with cancer, cardiovascular disease, psychiatric illness, or kidney disease,
7. with uncontrolled diabetes mellitus or hypertension,
8. with sleep disorders other than insomnia,
9. allergic to lactobacillus,
10. reported tobacco, alcohol, caffeine or drug addiction,
11. traveled to different time zone in long-distance trip within the last month,
12. participated in other interventional studies within the last three months, and
13. evaluated as unsuitable participant by PI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
60 Years
Study:
NCT06361368
Study Brief:
Protocol Section:
NCT06361368