Akk09 in Adults With Constipation

NCT07529457 | Not Yet Recruiting

• 1 other identifier: WK20260329
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

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.

  8 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

Participants assigned to this group will be administered Akk09 on a daily basis for 8 weeks.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

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

Interventions

Maltodextrin DIETARY_SUPPLEMENT

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

Placebo group

Probiotic DIETARY_SUPPLEMENT

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

Probiotic group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Other subjects considered inappropriate for participation by the investigator.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Suzhou Ninth People's Hospital

Suzhou, Jiangsu, 215000, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Probiotics; maltodextrin

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Central Study Contacts

Ying Jin

CONTACT

18336086291; 1959643812@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2026
• First Posted: April 14, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): May 20, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-03

Locations

CN (1)