Lactobacillus-containing Cultured Milk Drink Alleviates Depression Score Among Adults With Irritable Bowel Syndrome

Not Applicable

• Conditions: Irritable Bowel Syndrome With Subthreshold Depression
• Interventions: Dietary Supplement: Placebo cultured milk drink; Dietary Supplement: Lactobacillus containing cultured milk drink

• Registration Number: NCT05266443
• Lead Sponsor: National University of Malaysia

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).

Study Timeline

• Study Start: 2019-11-22
• Status Verified: 2022-02
• Study First Submitted: 2022-02-23
• Study First Submitted QC: 2022-02-23
• Last Update Submitted: 2022-02-23
• Study First Posted: 2022-03-04
• Last Update Posted: 2022-03-04
• Primary Completion: 2022-06-30
• Study Completion: 2022-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Irritable bowel syndrome with normal mood receiving placebo	Placebo cultured milk drink	A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be supplemented with placebo drinks.
Irritable bowel syndrome with normal mood receiving probiotics	Lactobacillus containing cultured milk drink	A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R less than 16 will be given lactobacillus-containing cultured milk drinks.
Irritable bowel syndrome with subthreshold depression receiving probiotics	Lactobacillus containing cultured milk drink	A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be given lactobacillus-containing cultured milk drinks.
Irritable bowel syndrome with subthreshold depression receiving placebo	Placebo cultured milk drink	A total of 35 patients diagnosed with IBS as per Rome IV criteria who scored CESD-R of 16 or above will be supplemented with placebo drinks.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
Depression biomarker	12 weeks	Blood samples collected will be analysed to measure the serum serotonin level of patients with IBS.
Acute stress biomarker	12 weeks	Morning blood sample will be collected to measure serum cortisol level among patients with IBS.

Trial Locations

Locations (1)

Universiti Kebangsaan Malaysia; 🇲🇾 Bandar Tun Razak, Kuala Lumpur, Malaysia