Probiotics for Alleviating Functional Constipation in Adults
NCT ID: NCT06637397
Last Updated: 2024-10-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-05-30
2024-11-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Probiotic Group
Participants receive one sachet per day containing probiotic BC99 and maltodextrin (Week 0 to Week8).
Probiotic
During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
Placebo Group
Participants receive one sachet per day containing maltodextrin only, serving as the placebo(Week 0 to Week8).
Placebo
During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
Interventions
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Probiotic
During the intervention, participants can consume BC99 daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
Placebo
During the intervention, participants can consume maltodextrin daily and any adverse reactions were noted. Stool and serum samples were collected for analysis of 16S rRNA and serum inflammatory markers. Changes in intestinal flora and inflammatory factors before and after supplementation were assessed.
Eligibility Criteria
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Inclusion Criteria
2. Patients with chronic constipation (disease duration exceeding 6 months, with fewer than 3 bowel movements per week and/or Bristol stool form scale types 1 and 2);
3. Able to complete the study according to the requirements of the experimental protocol;
4. Patients who have signed the informed consent form;
5. Research participants (including male participants) who do not have fertility plans from 14 days before screening to 6 months after the end of the trial and are willing to take effective contraceptive measures voluntarily.
Exclusion Criteria
2. Patients who have changed their diet during the study period;
3. Patients with severe allergies and immune deficiencies;
4. Female patients who are pregnant, breastfeeding, or have plans to become pregnant;
5. Patients with severe diseases in vital organs such as cardiovascular, lung, liver, and kidney, as well as severe metabolic diseases such as diabetes, thyroid disease, malignant tumors, and severe immune system diseases;
6. Individuals who have used antibiotics within the past two weeks;
7. Individuals with severe psychological or mental illnesses;
8. Participants who have not consumed the tested samples as required or failed to follow up on time, resulting in an inability to determine the effectiveness;
9. Other research participants deemed unsuitable for participation by the researchers.
18 Years
70 Years
ALL
Yes
Sponsors
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Wecare Probiotics Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Henan University of Science and Technology
Luoyang, Henan, China
The School of Food and Bioengineering, Henan University of Science and Technolog
Luoyang, Henan, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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WK2024007
Identifier Type: -
Identifier Source: org_study_id
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