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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
200
Patients receive the formula probiotic for consecutive 8 weeks ( one sachet per day ).
Patients receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
Nanjing, Jiangsu, China
Hamilton Depression Rating Scale
Depressive symptoms as measured with the Hamilton Rating Scale for Depression. The score rangs from 0 to 53. The higher score means severer depressive symptoms.
Time frame: Change from baseline score to intervention measurements at 4 and 8 weeks
Patient Assessment of Constipation Symptom
Constipation symptoms as measured with the Patient Assessment of Constipation Symptom. The score ranges from 0 to 48. The higher score means severer constipated symptoms.
Time frame: changes from baseline score to intervention measurements at 4 and 8 weeks
Serum Il-1β
Serum Il-1β levels before and after intervention assessed by ELISA.
Time frame: changes from baseline level to intervention measurements at 4 and 8 weeks
Serum Il-6
Serum Il-6 levels before and after intervention assessed by ELISA.
Time frame: changes from baseline level to intervention measurements at 4 and 8 weeks
Serum TNF-α
Serum TNF-α levels before and after intervention assessed by ELISA.
Time frame: changes from baseline level to intervention measurements at 4 and 8 weeks
Serum cortisol
Serum cortisol levels before and after intervention assessed by ELISA.
Time frame: changes from baseline level to intervention measurements at 4 and 8 weeks
Serum Brain-derived neurotrophic factor
Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA.
Time frame: changes from baseline level to intervention measurements at 4 and 8 weeks
Serum concentrations of tryptophan metabolites
Serum concentrations of tryptophan metabolites quantified by High-Performance Liquid Chromatography and Mass Spectrometry
Time frame: Changes from baseline level to intervention measurements at 4 and 8 weeks
Serum concentrations of bile acid
Quantification by High-Performance Liquid Chromatography and Mass Spectrometry
Time frame: Changes from baseline level to intervention measurements at 4 and 8 weeks
Fecal microbiome
Fecal microbiome measured by next generation sequencing
Time frame: Changes from baseline to intervention measurements at 4 and 8 weeks
Stool form
Stool form measured with the Bristol Stool Form Scale, which classify the form of human faeces into seven types, successively named type 1 to type 7. Types 1 and 2 indicate constipation, with 3 and 4 being the ideal stools as they are easy to defecate while not containing excess liquid, 5 indicating lack of dietary fiber, and 6 and 7 indicate diarrhoea.
Time frame: Change from baseline score to intervention measurements at 4 and 8 weeks
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