Clinical trial NCT05266443: Lactobacillus-containing Cultured Milk Drink Alleviates Depression Score Among Adults With Irritable Bowel Syndrome
Official title: The Efficacy of Lactobacillus-containing Cultured Milk Drink in Alleviating Subthreshold Depression Among Adults With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome With Subthreshold Depression
Keywords: irritable bowel syndrome
subthreshold depression
probiotics
IBS
subclinical depression
Lead sponsor: National University of Malaysia
Sponsor class: OTHER
Collaborators: name: Cotra Enterprises Sdn. Bhd.
First posted: 2022-03-04
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Depression score
timeFrame: 12 weeks
measure: Depression severity scale
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life score
timeFrame: 12 weeks
measure: IBS severity score
timeFrame: 12 weeks
measure: Acute stress biomarker
timeFrame: 12 weeks
measure: Depression biomarker
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Bandar Tun Razak
country: Malaysia
facility: Universiti Kebangsaan Malaysia
state: Kuala Lumpur
Study officials:
affiliation: Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
name: Prof. Dr. Raja Affendi Raja Ali
role: PRINCIPAL_INVESTIGATOR
References: