Probiotic Intervention in 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: GUT99 1, Placebo, GUT99 2.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Function. 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
- Center list to be confirmed — check the primary protocol.
- 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
To evaluate the effects of probiotic intervention on gastrointestinal function in patients with constipation after 4 weeks of treatment, and to explore its potential effects on immune status and bone metabolism.
Interventions
- Dietary supplement GUT99 1
Taken orally once daily for 8 weeks (120B). - Dietary supplement Placebo
Taken orally once daily for 8 weeks. - Dietary supplement GUT99 2
Taken orally once daily for 8 weeks (1000B).
Primary outcome measures
- Changes in stool consistency [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- Aged 18-65 years.
- Patients with constipation, defined as fewer than three bowel movements per week and/or Bristol Stool Form Scale (BSFS) types 1-2.
- Able to comply with the study protocol and complete the study procedures.
- Participants who have voluntarily signed the informed consent form.
- Participants (including male participants) must have no plans for pregnancy from 14 days before screening until 6 months after the end of the study and must agree to use effective contraception during this period.
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Exclusion criteria
- Individuals who have recently taken products with similar functions to the investigational product that may affect the evaluation of study outcomes.
- Participants who plan to change their dietary habits during the study period.
- Patients with severe allergies or immunodeficiency.
- Women who are pregnant, breastfeeding, or planning to become pregnant.
- Patients with severe diseases of major organs such as the cardiovascular system, lungs, liver, or kidneys, or those with severe metabolic diseases (e.g., diabetes or thyroid disorders), malignant tumors, or severe immune system diseases.
- Individuals who have used antibiotics within the past two weeks.
- Individuals with severe psychological or psychiatric disorders.
- Participants who fail to take the investigational product as required or fail to attend scheduled follow-up visits, resulting in an inability to determine treatment efficacy.
- Any other participants considered unsuitable for participation in the study by the investigator.
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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
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07462494 · WK20260304