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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-10-31

Study Completion Date

2026-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Constipation Gastrointestinal Discomfort

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Data encoder, Statistician

Study Groups

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Probiotic

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

Group Type EXPERIMENTAL

Experimental: Probiotic with LcS

Intervention Type OTHER

Probiotic drink with LcS will be consumed once per day for four weeks

Control

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

Group Type PLACEBO_COMPARATOR

Control

Intervention Type OTHER

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

Interventions

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Experimental: Probiotic with LcS

Probiotic drink with LcS will be consumed once per day for four weeks

Intervention Type OTHER

Control

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

59 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes