LcS-fermented milk for constipation in Filipino adults
The Efficacy of Fermented Milk Drink With Lacticaseibacillus Paracasei Strain Shirota (LcS) on Relieving Constipation-Related Symptoms of Filipino Adults
This trial will test whether a daily probiotic drink containing Lacticaseibacillus paracasei strain Shirota (LcS) helps Filipino adults with constipation get softer stools and more regular bowel movements and reduce gastrointestinal discomfort.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 59 Years |
| Sex | All |
| Sponsor | University of Santo Tomas Academic / other |
| Locations | 1 site (Manila, Manila) |
| Trial ID | NCT07083596 on ClinicalTrials.gov |
What this trial studies
Adults aged 18–59 with constipation-related symptoms will be enrolled at the University of Santo Tomas and assigned to either a daily LcS probiotic drink or a control group for four weeks. Participants will keep their usual physical activity and consume the study drink once a day while researchers track stool consistency (Bristol Stool Form Scale), stool frequency and duration, and gastrointestinal discomfort. Key exclusions include recent antibiotic use, high-fiber diets, dairy allergy or lactose intolerance, pregnancy, and chronic diseases that could affect results. Outcomes after four weeks in the probiotic group will be compared to the control group to see if there are meaningful differences.
Who should consider this trial
Good fit: Filipino men and women aged 18–59 who are otherwise apparently healthy and have hard or lumpy stools (Bristol 1–2) in at least 25% of weekly bowel movements and can store the product cold at home are ideal candidates.
Not a fit: People with constipation from organic or neurologic causes, recent antibiotic use, high habitual fiber intake, dairy allergy or lactose intolerance, pregnancy or major chronic illnesses are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the probiotic drink could provide a simple daily option to soften stools, increase bowel frequency, and reduce gastrointestinal discomfort in adults with constipation.
How similar studies have performed: Previous studies of probiotics, including formulations with LcS, have shown mixed but sometimes positive effects on stool frequency and consistency in adults with constipation.
Eligibility criteria
Show full inclusion / exclusion 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: 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
Where this trial is running
Manila, Manila
- University of Santo Tomas — Manila, Manila, Philippines (Recruiting)
Study contacts
- Principal investigator: Diane S MENDOZA-SARMIENTO, Ph.D in Health Research — University of Santo Tomas
- Study coordinator: Diane S Mendoza-Sarmiento, Ph.D
- Email: dsmendoza@ust.edu.ph
- Phone: +639088738336
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.