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NCT Number: NCT07083596

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

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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Key information

Conditions

Constipation Gastrointestinal Discomfort Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Santo Tomas

Manila, 1015, Philippines

Location status: Recruiting

Location contact

Diane S Mendoza-Sarmiento, Ph.D in Health Research

CONTACT

[email protected]

+639088738336

Nicole Sison, MS in Food Science

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Experimental: Probiotic with LcS

Other

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

Control

Other

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

Primary outcomes

  1. Change in stool consistency

    Time frame: Four weeks

    Bristol Stool Consistency Score:

    Type 1: Separate hard lumps, like nuts (hard to pass); Severe Constipation. Type 2: Sausage-shaped, but lumpy; Mild Constipation. Type 3: Like a sausage, but with cracks on its surface; Normal. Type 4: Like a sausage or snake, smooth and soft; Normal. Type 5: Soft blobs with clear-cut edges (passed easily); Borderline Normal. Type 6: Fluffy pieces with ragged edges, a mushy stool; Mild diarrhea. Type 7: Watery, no solid pieces, entirely liquid; Severe diarrhea.

Secondary outcomes

  1. Change in the Frequency of Bowel Movement

    Time frame: four weeks

    Frequency of Bowel Movement- recorded as the number of bowel movements per day and reported as the daily average bowel movement in a week

  2. Change in the Duration of Bowel Movement

    Time frame: Four weeks

    Duration of Bowel movement will be recorded in minutes in the lavatory per bowel movement per day and reported as the daily average minutes in a week.

  3. Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms)

    Time frame: four weeks

    This includes measures of abdominal discomfort and pain, painful bowel movement, bloating, a sense of incomplete bowel movement, straining during bowel movement, and unsuccessful bowel movement using a five-point scale (PAC-SYM).

Study contacts

Contact information is provided by the study sponsor or research team.

Diane S Mendoza-Sarmiento, Ph.D

CONTACT

[email protected]

+639088738336

Nicole Kate D Sison, MS in Food Science

CONTACT

[email protected]

+639613634908

Sponsors and collaborators

Lead sponsor

University of Santo Tomas

Other

Collaborators

  • Yakult Honsha Co., LTD

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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