Irritable Bowel Syndrome With Subthreshold Depression
Conditions
Keywords
irritable bowel syndrome, subthreshold depression, probiotics, IBS, subclinical depression
Brief summary
Irritable bowel syndrome (IBS) is frequently associated with any form of psychiatric comorbidities including subthreshold or subclinical depression. Modification of gut ecology with probiotics has implicitly improved IBS and depressive symptoms. However, the efficacy of probiotics on IBS with existing subthreshold depression remain elusive. Therefore, the aim of this study is to evaluate the effects of lactobacillus-containing cultured milk drink on depression scores in adults diagnosed with IBS.
Detailed description
A total of 140 subjects who fulfilled Rome IV criteria for IBS will be recruited from a tertiary medical centre and among public volunteers. The depression status and categories will be assessed using the Centre Epidemiologic Studies Depression Scale Revised questionnaire (CESD-R): normal mood (score\<16), or subthreshold depression (score\>16). The subjects are randomised and blinded into four groups: Group A (Normal mood with placebo, n=35), Group B (Normal mood with probiotics, n=35), Group C (Subthreshold depression with placebo, n=35) and Group D (Subthreshold depression with probiotics, n=35). The subjects will be instructed to consume two bottles of cultured milk drink daily for 12 weeks. The probiotic cultured milk drinks contained 10\^9 cfu L. CASEI-01 and LA-5. The severity of depression will be measured using Patient Health Questionnaire (PHQ-9) at pre- and post-12-week intervention. Secondary outcome on IBS symptoms severity will be assessed with IBS Symptoms Severity Score (IBS-SSS) and IBS Quality of Life (IBS-QOL).
Interventions
DIETARY_SUPPLEMENTLactobacillus containing cultured milk drink
Each bottle of 125ml cultured milk drink contains a billion colony forming unit (CFU) Lactobacillus acidophillus (LA-5) and Lactobacillus paracasei (L. CASEI-01). Each patient will be given 2 bottles to consume daily for a period of 12 weeks.
DIETARY_SUPPLEMENTPlacebo cultured milk drink
The placebo prepared was identical to the probiotic-containing product in terms of color, taste and packaging. However, there is no trace of live microorganism in this product.
Sponsors
Cotra Enterprises Sdn. Bhd.
National University of Malaysia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Both investigators and subjects will be blinded to the treatment products.
Intervention model description
This is a randomized and parallel study involving patients with IBS who attended gastroenterology clinics at Universiti Kebangsaan Malaysia Medical Center (UKMMC). The recruited subjects will be categorized according to their CESD-R scores and randomly allocated into receiving either placebo or probiotic-containing cultured milk drink for 12 weeks.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18 to 65 years old, * Meet ROME IV criteria for irritable bowel syndrome, * Consented to participate in the study.
Exclusion criteria
* Lactose intolerance, * Gastrointestinal disorders such as inflammatory bowel diseases, liver diseases, pancreatic diseases or malignancies, * Any neurological diseases or malignancies, * Pregnant and lactating mothers, * Any metabolic diseases such as hypertension, hypercholesterolaemia, diabetes mellitus, hyper- and hypothyroidism. * Known psychiatric diagnoses or/and consume psychotropic drugs, * Ongoing electroconvulsive therapy (ECT), * Consumption of antibiotics, probiotics, prebiotics, symbiotics products, laxatives, antispasmodics, and/or anticholinergics who refuse to consent for participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depression score | 12 weeks | The Centre for Epidemiologic Studies Depression Scale Revised Version (CESD-R) will be used to classify the patients according to their depression status. |
| Depression severity scale | 12 weeks | The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity scale for the patients. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life score | 12 weeks | The life quality of patients will be measured using the Irritable bowel syndrome Quality of Life Questionnaire (IBS-QOL). |
| IBS severity score | 12 weeks | Any changes in gastrointestinal symptoms severity related to IBS will be quantify using the Irritable bowel syndrome Severity Scoring System (IBS-SSS). |
| Acute stress biomarker | 12 weeks | Morning blood sample will be collected to measure serum cortisol level among patients with IBS. |
| Depression biomarker | 12 weeks | Blood samples collected will be analysed to measure the serum serotonin level of patients with IBS. |
Countries
Malaysia
Contacts
Primary ContactProf. Dr. Norfilza Mohd Mokhtar
Backup ContactProf. Dr. Raja Affendi Raja Ali
Outcome results
None listed