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
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
Treatments tested in this trial
- Probiotic
- Maltodextrin
Treatment groups
70 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov