Efficacy of LcS-Fermented Milk on Constipation-Related Symptoms in Filipino Adults

University of Santo Tomas

Status: Enrolling

Conditions: Gastrointestinal Discomfort; Constipation

Treatments: Other: Experimental: Probiotic with LcS; Other: Control

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07083596

REC-2025-06-084-CT-AP

2025-06-084-CT-R1 (Other Identifier)

Details and patient eligibility

About

The primary purpose of this study is to investigate whether the consumption of a probiotic drink (with Lacticaseibacillus paracasei strain Shirota (LcS)) relieves constipation-related symptoms of Filipino adults, specifically its effect on stool consistency, frequency, and duration, and on gastrointestinal discomfort.

Full description

The goal of this clinical trial is to test if probiotic drink with LcS consumption can improve constipation-related symptoms. The main question[s] it aims to answer are:

• Will a probiotic drink with LcS improve stool consistency after four weeks?
• Will a probiotic drink with LcS improve stool frequency and duration after four weeks?
• Will a probiotic drink with LcS improve gastrointestinal discomfort after four weeks?

Participants will consume probiotic drink with LcS once a day for four weeks while maintaining their usual physical activity. Researchers will compare the control group and the probiotic group to see if there are differences in stool consistency, frequency and duration, and gastrointestinal symptoms.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Filipino adult male or female aged 18 to 59 years old
• Apparently healthy adults with constipation-related symptoms of hard to lumpy stools (Bristol Stool Form Scale 1-2) in 25% or more of defecations in a week
• With cold storage at home

Exclusion criteria

1. Habitual intake of food items containing probiotics and prebiotics as food supplements (previous 3 months, at least three times per week)
2. Constipation due to organic or neurologic origin
3. High fiber intake (>30 g/day)
4. Pregnant or lactating
5. Allergy to dairy products and/or lactose intolerance
6. Use of laxatives, anticholinergics and medications for constipation or diarrhea within the past three months
7. Use of antibiotics within the past two weeks
8. Presence of chronic diseases such as diabetes mellitus and its complications, cardiovascular diseases, kidney problems
9. GI condition that may interfere with the evaluation of the outcome such as hemorrhoids, intestinal obstruction and inflammatory bowel diseases
10. Recent history of any gastrointestinal surgery
11. Have pre-existing medical conditions like hypo- or hyperthyroidism and congenital abnormalities
12. Participation in another study with test product two months prior the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Probiotic

Experimental group

Description:

Probiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks

Treatment:

Other: Experimental: Probiotic with LcS

Control

Placebo Comparator group

Description:

Brochure containing recommendations to improve constipation will be provided at the end of study.

Treatment:

Other: Control