NCT07083596

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress10%
Apr 2026Oct 2026

First Submitted

Initial submission to the registry

July 6, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 24, 2025

Completed
9 months until next milestone

Study Start

First participant enrolled

April 22, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2026

Expected
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

5 months

First QC Date

July 6, 2025

Last Update Submit

April 27, 2026

Conditions

ConstipationGastrointestinal Discomfort

Keywords

probioticLacticaseibacillus paracasei strain Shirotaconstipation

Outcome Measures

Primary Outcomes (1)

  • Change in stool consistency

    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.

    Four weeks

Secondary Outcomes (3)

  • Change in the Frequency of Bowel Movement

    four weeks

  • Change in the Duration of Bowel Movement

    Four weeks

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

    four weeks

Study Arms (2)

Probiotic

EXPERIMENTAL

Probiotic drink with Lacticaseibacillus paracasei strain Shirota will be consumed once per day for four weeks. Brochure containing recommendations to improve constipation will be provided at the start of study.

Other: Experimental: Probiotic with LcS

Control

PLACEBO COMPARATOR

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

Other: Control

Interventions

Experimental: Probiotic with LcSOTHER

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

Probiotic
ControlOTHER

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

Control

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Santo Tomas

Manila, Manila, 1015, Philippines

RECRUITING

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Diane S MENDOZA-SARMIENTO, Ph.D in Health Research

    University of Santo Tomas

    PRINCIPAL INVESTIGATOR

  • Leslie Michelle M Dalmacio, Ph.D in Molecular Biology

    University of the Philippines-Manila

    STUDY CHAIR

Central Study Contacts

Diane S Mendoza-Sarmiento, Ph.D

CONTACT

+639088738336dsmendoza@ust.edu.ph

Nicole Kate D Sison, MS in Food Science

CONTACT

+639613634908ndsison@ust.edu.ph

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Data encoder, Statistician
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 6, 2025

First Posted

July 24, 2025

Study Start

April 22, 2026

Primary Completion (Estimated)

September 30, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

May 4, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

PH(1)