Adults With Constipation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Probiotic, Maltodextrin.
- Who it may be relevant to
- Registry conditions: Constipation. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
To Evaluate the Efficacy and Safety of Probiotics in Alleviating Constipation in Adults Through a Randomized, Double-blind, Placebo-controlled Trial
Overview
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.
Interventions
- 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.
Primary outcome measures
- Improvement in bowel function [Time frame: 8 weeks]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Suzhou Ninth People's Hospital — Suzhou
Identifiers
NCT: NCT07529457 · WK20260329