NCT07529457

Akk09 in Adults With Constipation

Effects of Akk09 Supplementation on Gastrointestinal Function, Inflammatory and Immune Responses, Gut Microbiota, Gut-Brain Axis, and Metabolic Profiles in Adults With Functional Constipation: A Randomized, Double-Blind, Placebo-Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 70 (estimated)
• Sponsor: Wecare Probiotics Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Constipation

Interventions

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

Timeline

• Start date: 2026-05-01
• Primary completion: 2027-03-01
• Completion: 2027-05-20
• First posted: 2026-04-14
• Last updated: 2026-04-14

Locations

1 site across 1 country: China