Probiotics Regulate Intestinal Health and Alleviate Anxiety

Wecare Probiotics

Status: Completed

Conditions: Anxiety Depression

Treatments: Dietary Supplement: probiotics group; Dietary Supplement: Placebo Group

Study type: Interventional

Funder types: Industry

Identifiers

NCT07353320

WK20251224

Details and patient eligibility

About

This study is a randomized, double-blind, placebo-controlled trial aimed primarily at investigating the effects of Weizmannia coagulans BC99 on alleviating anxiety and depression and the gut microbiota.

Enrollment: 79 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Adults aged 18-65 years.
2. Individuals experiencing scientific research, employment-related, or occupational stress, including graduate students or community-dwelling adults with job-related pressure.
3. A Hamilton Depression Rating Scale (HAMD-17) score ≥ 8 and/or a Hamilton 4) Anxiety Rating Scale (HAMA-14) score ≥ 7 at screening.

5)Ability and willingness to voluntarily participate in the study and to provide written informed consent prior to enrollment.

Exclusion criteria

1. A confirmed previous diagnosis of other psychiatric disorders, including intellectual disability, bipolar disorder, treatment-resistant depression, or suicidal ideation.
2. Pregnant or breastfeeding women.
3. Individuals with known food or drug allergies, or those with alcohol abuse or psychotropic substance abuse.
4. Use of antibiotics or probiotics known to affect gut microbiota for more than one week within one month prior to enrollment.
5. Participants who withdrew from the study, discontinued intervention, or were unable to complete the study for any reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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79 participants in 2 patient groups, including a placebo group

Experimental : probiotics group

Experimental group

Description:

5 billion CFU/day BC99 and protein powder; Storage: sealed, protected from light, placed in a cool and dry place.

Treatment:

Dietary Supplement: probiotics group

Placebo Comparator : placebo group

Placebo Comparator group

Description:

Dextrin powder, 1 bags per day; Storage: sealed, protected from light, placed in a cool and dry place.

Treatment:

Dietary Supplement: Placebo Group