Comorbidity of Depression and Constipation
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Patients receive the formula probiotic for consecutive 8 weeks ( one sachet per day ).
DIETARY_SUPPLEMENTPlacebo
Patients receive the placebo identical to probiotic for consecutive 8 weeks ( one sachet per day ).
Sponsors
The Affiliated Nanjing Hospital of Nanjing University of Chinese Medicine
China Agricultural University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale | Change from baseline score to intervention measurements at 4 and 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Serum Il-1β | changes from baseline level to intervention measurements at 4 and 8 weeks | Serum Il-1β levels before and after intervention assessed by ELISA. |
| Serum Il-6 | changes from baseline level to intervention measurements at 4 and 8 weeks | Serum Il-6 levels before and after intervention assessed by ELISA. |
| Serum TNF-α | changes from baseline level to intervention measurements at 4 and 8 weeks | Serum TNF-α levels before and after intervention assessed by ELISA. |
| Serum cortisol | changes from baseline level to intervention measurements at 4 and 8 weeks | Serum cortisol levels before and after intervention assessed by ELISA. |
| Patient Assessment of Constipation Symptom | changes from baseline score to intervention measurements at 4 and 8 weeks | 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. |
| Serum concentrations of tryptophan metabolites | Changes from baseline level to intervention measurements at 4 and 8 weeks | Serum concentrations of tryptophan metabolites quantified by High-Performance Liquid Chromatography and Mass Spectrometry |
| Serum concentrations of bile acid | Changes from baseline level to intervention measurements at 4 and 8 weeks | Quantification by High-Performance Liquid Chromatography and Mass Spectrometry |
| Fecal microbiome | Changes from baseline to intervention measurements at 4 and 8 weeks | Fecal microbiome measured by next generation sequencing |
| Stool form | Change from baseline score to intervention measurements at 4 and 8 weeks | 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. |
| Serum Brain-derived neurotrophic factor | changes from baseline level to intervention measurements at 4 and 8 weeks | Serum Brain-derived neurotrophic factor levels before and after intervention assessed by ELISA. |
Countries
China
Contacts
Primary ContactFazheng Ren, PhD
Backup ContactXifan Wang, PHD
Outcome results
None listed