To Evaluate the Safety and Efficacy of Pediococcus Acidilactici PA53 in Relieving Constipation in Adults

ConditionConstipation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorWecare Probiotics Co., Ltd.

About this trial

To study the improvement of constipation symptoms, quality of life and mental state, intestinal function, intestinal hormones, inflammation and immunity, and intestinal flora of constipation subjects after 8-week intervention with Pediococcus acidilactici PA53.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Short-term use of items with similar functions to the subject, which affects the judge of the result;

Those who changed their diet type during the study period;

People with severe allergies and immune deficiencies;

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Probiotic

    Dietary supplement

    The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

  • Maltodextrin

    Dietary supplement

    The experimental phase of this study had last 8 weeks and each patient will make 3 visits (week 0, week 4, week 8).

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: ProbioticExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Constipation symptom improvement

Assessing the improvement of constipation in patients using the Bristol Stool Form Scale (BSFS) . In this scale, higher scores indicate softer stool textures, closer to liquid consistency. Scores of 4, 5, and 6 are generally considered ideal stool characteristics.

Time frame
8 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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