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

NCT05266443 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2022-03-04

No results posted yet for this study

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.

Conditions

  • Irritable Bowel Syndrome With Subthreshold Depression

Interventions

DIETARY_SUPPLEMENT

Lactobacillus 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_SUPPLEMENT

Placebo 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 & Collaborators

  • Cotra Enterprises Sdn. Bhd.

    collaborator UNKNOWN

  • National University of Malaysia

    lead OTHER

Principal Investigators

  • Prof. Dr. Raja Affendi Raja Ali · Gastroenterology Unit, Faculty of Medicine, Universiti Kebangsaan Malaysia, Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-22
Primary Completion
2022-06-30
Completion
2022-07-31

Countries

  • Malaysia

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05266443 on ClinicalTrials.gov