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NCT Number: NCT07529457

Adults With Constipation

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 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 Akk09 supplementation.

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Key information

Conditions

Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Jin

CONTACT

[email protected]

18336086291

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 14, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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