Effect of Probiotic on Comorbidity of Depression and Constipation

China Agricultural University

Status: Unknown

Conditions: Comorbidity of Depression and Constipation

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT04570072

CAUDepression-02

Details and patient eligibility

About

Depressive disorder, also known as depression, is a type of mood disorder characterized by persistent low mood. The incidence of depression worldwide is about 6%. The high comorbidity rate between depression and constipation indicated the role of the gut-brain axis in depression. Growing evidence suggested that the gut microbiota plays a key role in the development of depression. Probiotics can effectively improve constipation and regulate gut microbiota, and showed potential in alleviating depression. This study investigated the effect of formula probiotic (containing Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum) on the comorbidity of depression and constipation.

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Normal body mass index ≥ 18.5 until ≤ 29.9
• Hamilton Rating Scale for Depression (HAMD-17) score not less than 8
• Meet the ROME III criteria for functional constipation
• Agreed to intake study product during the study period
• Agreed to sign written informed consent

Exclusion criteria

• Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study
• Investigator's uncertainty about the willingness or ability of subject to comply with the protocol requirements
• Persons with a milk protein allergy, lactose intolerance
• Pregnant or breastfeeding women
• Subject had other serious diseases

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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200 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Formula probiotic contains freeze-dried Lactobacillus paracasei, Bifidobacterium animals, Bifidobacterium longum, Bifidobacterium bifidum, and Lactobacillus plantarum, each at a dosage of 3.0 × 10\^10 colony forming unit per 2g sachet.

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Placebo made with only the excipients. The placebo sachet was matched to the study probiotic products for taste, color, and size.

Treatment:

Dietary Supplement: Placebo