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

Primary Purpose

Irritable Bowel Syndrome With Subthreshold Depression

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
Lactobacillus containing cultured milk drink
Placebo cultured milk drink
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Subthreshold Depression focused on measuring irritable bowel syndrome, subthreshold depression, probiotics, IBS, subclinical depression

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts 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.

Sites / Locations

  • Universiti Kebangsaan MalaysiaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Placebo Comparator

Experimental

Arm Label

Irritable bowel syndrome with normal mood receiving placebo

Irritable bowel syndrome with normal mood receiving probiotics

Irritable bowel syndrome with subthreshold depression receiving placebo

Irritable bowel syndrome with subthreshold depression receiving probiotics

Arm 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.

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.

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.

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.

Outcomes

Primary Outcome Measures

Depression score
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
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity scale for the patients.

Secondary Outcome Measures

Quality of life score
The life quality of patients will be measured using the Irritable bowel syndrome Quality of Life Questionnaire (IBS-QOL).
IBS severity score
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
Morning blood sample will be collected to measure serum cortisol level among patients with IBS.
Depression biomarker
Blood samples collected will be analysed to measure the serum serotonin level of patients with IBS.

Full Information

First Posted
February 23, 2022
Last Updated
February 23, 2022
Sponsor
National University of Malaysia
Collaborators
Cotra Enterprises Sdn. Bhd.
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1. Study Identification

Unique Protocol Identification Number
NCT05266443
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 22, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia
Collaborators
Cotra Enterprises Sdn. Bhd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Subthreshold Depression
Keywords
irritable bowel syndrome, subthreshold depression, probiotics, IBS, subclinical depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
Both investigators and subjects will be blinded to the treatment products.
Allocation
Randomized
Enrollment
140 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Irritable bowel syndrome with normal mood receiving placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Irritable bowel syndrome with normal mood receiving probiotics
Arm Type
Active Comparator
Arm 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.
Arm Title
Irritable bowel syndrome with subthreshold depression receiving placebo
Arm Type
Placebo Comparator
Arm 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.
Arm Title
Irritable bowel syndrome with subthreshold depression receiving probiotics
Arm Type
Experimental
Arm 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus containing cultured milk drink
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo cultured milk drink
Intervention Description
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.
Primary Outcome Measure Information:
Title
Depression score
Description
The Centre for Epidemiologic Studies Depression Scale Revised Version (CESD-R) will be used to classify the patients according to their depression status.
Time Frame
12 weeks
Title
Depression severity scale
Description
The Patient Health Questionnaire-9 (PHQ-9) will be used to assess the severity scale for the patients.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Quality of life score
Description
The life quality of patients will be measured using the Irritable bowel syndrome Quality of Life Questionnaire (IBS-QOL).
Time Frame
12 weeks
Title
IBS severity score
Description
Any changes in gastrointestinal symptoms severity related to IBS will be quantify using the Irritable bowel syndrome Severity Scoring System (IBS-SSS).
Time Frame
12 weeks
Title
Acute stress biomarker
Description
Morning blood sample will be collected to measure serum cortisol level among patients with IBS.
Time Frame
12 weeks
Title
Depression biomarker
Description
Blood samples collected will be analysed to measure the serum serotonin level of patients with IBS.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Dr. Norfilza Mohd Mokhtar
Phone
+60391458424
Email
norfilza@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Prof. Dr. Raja Affendi Raja Ali
Phone
+60391455022
Email
draffendi@ppukm.ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Raja Affendi Raja Ali
Organizational Affiliation
Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universiti Kebangsaan Malaysia
City
Bandar Tun Razak
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Norfilza Mohd Mokhtar
Phone
+60391458424
Email
norfilza@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Prof. Dr. Raja Affendi Raja Ali
Phone
+60391455022
Email
draffendi@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Marlynna Sarkawi

12. IPD Sharing Statement

Plan to Share IPD
No

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

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