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Recruiting NCT07083596

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

No phase Interventional Constipation Gastrointestinal Discomfort

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Experimental: Probiotic with LcS, Control.
Who it may be relevant to
Registry conditions: Constipation, Gastrointestinal Discomfort. Basic parameters: 18 years — 59 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Philippines
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

The Efficacy of Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota (LcS) on Relieving Constipation-Related Symptoms of Filipino Adults

Overview

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.

Detailed 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.

Interventions

  • Other Experimental: Probiotic with LcS
    Probiotic drink with LcS will be consumed once per day for four weeks
  • Other Control
    Brochure containing recommendations to improve constipation will be provided at start of study.

Primary outcome measures

  • Change in stool consistency [Time frame: Four weeks]
Secondary outcome measures (3)
  • Change in the Frequency of Bowel Movement [Time frame: four weeks]
  • Change in the Duration of Bowel Movement [Time frame: Four weeks]
  • Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms) [Time frame: four weeks]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Philippines · 1 center
  • University of Santo Tomas — Manila

Identifiers

NCT: NCT07083596 · REC-2025-06-084-CT-AP · 2025-06-084-CT-R1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗