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

National University of Malaysia

Status: Unknown

Conditions: Irritable Bowel Syndrome With Subthreshold Depression

Treatments: Dietary Supplement: Placebo cultured milk drink; Dietary Supplement: Lactobacillus containing cultured milk drink

Study type: Interventional

Funder types: Other

Identifiers

NCT05266443

UKM PPI/111/8/JEP-2019-312

Details and patient eligibility

About

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.

Full 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).

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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140 participants in 4 patient groups, including a placebo group

Irritable bowel syndrome with normal mood receiving placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo cultured milk drink

Irritable bowel syndrome with normal mood receiving probiotics

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus containing cultured milk drink

Irritable bowel syndrome with subthreshold depression receiving placebo

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Placebo cultured milk drink

Irritable bowel syndrome with subthreshold depression receiving probiotics

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Lactobacillus containing cultured milk drink