Probiotic Intervention in Constipation

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorWecare Probiotics Co., Ltd.

About this trial

To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Aged 18-65 years.

Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.

Able to comply with the study protocol and complete the study procedures.

Participants who have voluntarily signed the informed consent form.

Disqualifiers

Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.

Participants who plan to change their dietary habits during the study period.

Patients with severe allergies or immunodeficiency.

Women who are pregnant, breastfeeding, or planning to become pregnant.

Trial design

Design model

Parallel

Treatments tested in this trial

  • GUT99 1

    Dietary supplement

    Taken orally once daily for 8 weeks (120B).

  • Placebo

    Dietary supplement

    Taken orally once daily for 8 weeks.

  • GUT99 2

    Dietary supplement

    Taken orally once daily for 8 weeks (1000B).

Treatment groups

30 Participants
are divided into 3 treatment groups
Group A: Probiotic group AExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Group C: Probiotic group BExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Changes in stool consistency

Stool consistency will be evaluated using the Bristol Stool Form Scale (BSFS) to assess the improvement of constipation symptoms in patients receiving probiotic intervention.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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

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