Probiotics Alleviate Functional Constipation in Adults

Launched by WECARE PROBIOTICS CO., LTD. · Mar 10, 2025

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Eligibility criteria

• Inclusion Criteria:
• 1. Chinese adults aged 18-70 who meet the following Rome-IV diagnostic criteria for Functional constipation:
• i. If the following symptoms started at least 6 months ago and have been present for the past 3 months with two or more of the following:
• • 1. Straining during more than 25% of defecations
• • 2. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
• • 3. Sensation of incomplete evacuation more than 25% of defecations
• • 4. Sensation of anorectal obstruction/blockage more than 25% of defecations
• • 5. Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
• • 6. Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
• • 2. Able to complete the study according to the requirements of the trial protocol;
• • 3. Patients who have signed the informed consent form;
• • 4. Research participants (including male participants) who have no fertility plans from 14 days before screening until 6 months after the end of the trial and are willing to take effective contraceptive measures.
• • Only those who meet all the above conditions can be selected for the study. -
• Exclusion Criteria:
• • 1. The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
• • 2. Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
• • 3. Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
• • 4. Currently have, or have had in the past 2 years, any gastrointestinal conditions such as: Crohn's disease, celiac disease, Ulcerative colitis, Malignant tumor of the colon.
• • 5. Medical history of cardiovascular, liver, or renal diseases; alcoholics.
• • 6. Hypersensitivity to probiotics or the ingredients used in this study.
• • 7. Pregnancy or breastfeeding.
• • 8. Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -