Akk09 in Adults With Constipation

April 7, 2026 updated by: Wecare Probiotics Co., Ltd.

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215000
        • Suzhou Ninth People's Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Men and women aged between 18 and 65 years;
  2. Participants presenting with constipation, characterized by <3 spontaneous bowel movements per week or BSFS stool types 1-2;
  3. Capable of following the study protocol and completing all required assessments; Individuals who have voluntarily signed the informed consent form;
  4. 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:

  1. Intake of similar functional products within a short period prior to enrollment that could influence study results;
  2. Participants who significantly alter their habitual diet during the trial;
  3. Individuals with severe allergic conditions or impaired immune function;
  4. Women who are pregnant, lactating, or intending to conceive;
  5. Patients with serious underlying diseases affecting major organs or metabolic systems;
  6. Antibiotic treatment within 2 weeks before enrollment;
  7. Individuals with severe mental or psychological disorders;
  8. Non-compliance with study requirements, including improper intake or missed follow-ups;
  9. Other subjects considered inappropriate for participation by the investigator.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic group
Participants assigned to this group will be administered Akk09 on a daily basis for 8 weeks.
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.
Placebo Comparator: Placebo group
Participants in the control group will receive a maltodextrin-based placebo once daily for 8 weeks, identical in appearance and usage to the intervention.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in bowel function
Time Frame: 8 weeks
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.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wecare Probiotics Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

May 20, 2027

Study Registration Dates

First Submitted

March 27, 2026

First Submitted That Met QC Criteria

April 7, 2026

First Posted (Actual)

April 14, 2026

Study Record Updates

Last Update Posted (Actual)

April 14, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WK20260329

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Constipation

Clinical Trials on Probiotic

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mongolia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe