Status:
UNKNOWN
Lactobacillus-containing Cultured Milk Drink Alleviates Depression Score Among Adults With Irritable Bowel Syndrome
Lead Sponsor:
National University of Malaysia
Collaborating Sponsors:
Cotra Enterprises Sdn. Bhd.
Conditions:
Irritable Bowel Syndrome With Subthreshold Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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 imp...
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...
Eligibility Criteria
Inclusion
- Aged 18 to 65 years old,
- Meet ROME IV criteria for irritable bowel syndrome,
- Consented to participate in the study.
Exclusion
- 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.
Key Trial Info
Start Date :
November 22 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 31 2022
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05266443
Start Date
November 22 2019
End Date
July 31 2022
Last Update
March 4 2022
Active Locations (1)
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1
Universiti Kebangsaan Malaysia
Bandar Tun Razak, Kuala Lumpur, Malaysia, 56000