Probiotic Improve Constipation

ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWecare Probiotics Co., Ltd.

About this trial

To evaluate the efficacy and safety of probiotic as a food supplement in regulating bowel habits in patients with chronic constipation, and to compare it with placebo.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Those who have taken a substance with a similar function to the test subject in a short period of time, affecting their judgment of the results;

Patients who changed their diet during the study;

Patients with severe allergies and immunodeficiency;

Pregnant, breastfeeding, or women planning to become pregnant;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

  • Placebo

    Dietary supplement

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

  • High-activity probiotic probiotic

    Dietary supplement

    The intervention period of this study will last for 8 weeks (56 days), during which each participant will attend three study visits scheduled at baseline (Week 0), Week 4, and Week 8.

Treatment groups

105 Participants
are divided into 3 treatment groups
Group A: Probiotic GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention
Group C: High-activity probiotic groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Improvement of constipation symptoms

Improvement in constipation was assessed using the Bristol Stool Characteristics Scale (BSFS), primarily observing the shift in stool type from type 1-2 (hard stool/constipation) to type 3-4 (normal/ideal soft stool).

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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