Status:
NOT_YET_RECRUITING
GUTPROH: Probiotic-Herbal Formula for Self-Reported Constipation in Community Adults
Lead Sponsor:
Beijing Hospital
Collaborating Sponsors:
Chinese Aging Well Association
Conditions:
Functional Constipation (FC)
Eligibility:
All Genders
35+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to evaluate the effects of probiotic combined with or without herbal powder on relieving constipation and improving the gut microbiota in community - dwelling people...
Eligibility Criteria
Inclusion
- Aged 35 years or older.
- Self - reported good comprehensive physical health status. Have complaints of irregular bowel movement frequency and a need for improved defecation, or have a spontaneous defecation frequency of less than 3 times per week in the 2 weeks before administration, or meet two or more of the following Rome IV criteria for functional constipation (FC): ① \>25% of defecations are difficult; ② \>25% of defecations are dry, hard, or pellet - shaped; ③ \>25% of defecations have a sense of incomplete evacuation; ④ \>25% of defecations have a feeling of anorectal obstruction or blockage; ⑤ \>25% of defecations require manual assistance; ⑥ Fewer than 3 spontaneous defecations per week.
- Provide written informed consent voluntarily before the study and be able to fill out the subject log card and research questionnaire as required by the trial protocol.
Exclusion
- Frail elderly people with a score of ≥3 on the FRAIL Frailty Screening Scale.
- Self - reported presence of loose stools.
- Those who have undergone surgery within 30 days, had an acute gastrointestinal disease within 30 days, or have been diagnosed with severe organic diseases causing defecation difficulties (such as colon cancer, intestinal obstruction, inflammatory bowel disease, etc.).
- Patients with severe systemic diseases in the acute phase of cardiovascular, liver, kidney, and hematopoietic systems.
- Patients with symptoms of yin deficiency and internal heat, such as dry mouth, night sweats, restlessness of the five centers (palms, soles, and chest), hard and dry stools with bad breath, red tongue with yellow coating.
- Those who have taken antibiotics within 30 days before the start of the trial.
- Those who have taken probiotics, fermented products, other laxative drugs, or health supplements within 14 days before the start of the trial (i.e., during the wash - out period).
- Those who have not signed the informed consent form. Other situations considered unsuitable for enrollment by the researchers.
Key Trial Info
Start Date :
July 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06955819
Start Date
July 10 2025
End Date
December 31 2025
Last Update
June 26 2025
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