Constipation, Gastrointestinal Discomfort
Conditions
Keywords
probiotic, Lacticaseibacillus paracasei strain Shirota, constipation
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.
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
OTHERExperimental: Probiotic with LcS
Probiotic drink with LcS will be consumed once per day for four weeks
OTHERControl
Brochure containing recommendations to improve constipation will be provided at start of study.
Sponsors
University of Santo Tomas
Yakult Honsha Co., LTD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Data encoder, Statistician
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in stool consistency | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in the Frequency of Bowel Movement | 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 |
| Change in the Duration of Bowel Movement | 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. |
| Change in the Gastrointestinal Well-being (Patient Assessment of Constipation Symptoms) | 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). |
Countries
Philippines
Contacts
CONTACTDiane S Mendoza-Sarmiento, Ph.D
CONTACTNicole Kate D Sison, MS in Food Science
PRINCIPAL_INVESTIGATORDiane S MENDOZA-SARMIENTO, Ph.D in Health Research
University of Santo Tomas
STUDY_CHAIRLeslie Michelle M Dalmacio, Ph.D in Molecular Biology
University of the Philippines-Manila
Outcome results
None listed