Health TrialsbyHealthPanel

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

ConditionsConstipationGastrointestinal Discomfort
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-59
SponsorUniversity of Santo Tomas

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Experimental: Probiotic with LcS

    Other intervention

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

  • Control

    Other intervention

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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ProbioticExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

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.

Time frame
Four weeks

Secondary outcomes

1

Change in the Frequency of Bowel Movement

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

Time frame
four weeks
2

Change in the Duration of Bowel Movement

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.

Time frame
Four weeks
3

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

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).

Time frame
four weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Santo Tomas

Lead sponsor

Yakult Honsha Co., LTD

Collaborator

Source ClinicalTrials.gov
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