Adults With Constipation
ConditionConstipation
Trial statusRecruiting
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 probiotics in adults with functional constipation. Participants will receive probiotics or placebo for 8 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 probiotic supplementation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Probiotics
Dietary supplementProbiotics will be administered orally once daily for 8 weeks. Study visits are scheduled at baseline (Week 0), Week 4, and Week 8.
Placebo
Dietary supplementPlacebo 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 groupsGroup A: Probiotic groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov