Not Yet RecruitingNot Applicable

Akk09 in Adults With Constipation

China70 participantsStarted 2026-05-01

Plain-language summary

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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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;
✕. Patients with serious underlying diseases affecting major organs or metabolic systems;
✕. Antibiotic treatment within 2 weeks before enrollment;
✕. Individuals with severe mental or psychological disorders;
✕. Non-compliance with study requirements, including improper intake or missed follow-ups;

What they're measuring

Improvement in bowel function

Timeframe: 8 weeks

Trial details

NCT IDNCT07529457

SponsorWecare Probiotics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-03-01

Contact for this trial

Ying Jin

18336086291 1959643812@qq.com

View on ClinicalTrials.gov More Constipation trials