Adults With Constipation

ConditionConstipation

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorWecare Probiotics Co., Ltd.

About this trial

This randomized, double-blind, placebo-controlled trial will assess the clinical effects of Akk09 in adults with functional constipation. Participants will receive Akk09 or placebo for 4 weeks. The study will evaluate changes in bowel habits and symptom burden, as well as alterations in host inflammatory status, immune modulation, microbial ecosystem dynamics, neuroendocrine signaling related to the gut-brain axis, and systemic metabolic responses, to characterize the overall physiological impact of BC09 supplementation.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Men and women aged between 18 and 65 years;

Participants presenting with constipation, characterized by <3 spontaneous bowel movements per week or BSFS stool types 1-2;

Capable of following the study protocol and completing all required assessments; Individuals who have voluntarily signed the informed consent form;

No plans for pregnancy from at least 14 days prior to screening through 6 months after the study, with agreement to use reliable contraception methods.

Disqualifiers

Intake of similar functional products within a short period prior to enrollment that could influence study results;

Participants who significantly alter their habitual diet during the trial;

Individuals with severe allergic conditions or impaired immune function;

Women who are pregnant, lactating, or intending to conceive;

Trial design

Design model

Parallel

Treatments tested in this trial

Probiotic
Dietary supplement
Akk09 will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.
Maltodextrin
Dietary supplement
Maltodextrin will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.

Treatment groups

70 Participants

are divided into 2 treatment groups

Group A: Probiotic groupExperimental treatment 1 intervention

Group B: Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Improvement in bowel function

Bowel function will be assessed using the Bristol Stool Form Scale (BSFS), with emphasis on the transition of stool types from harder forms (types 1-2) to softer, more normal forms (types 3-4) during the intervention period.

Time frame

8 weeks

Sponsors and contacts

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

Wecare Probiotics Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: