Probiotics Alleviate Functional Constipation in Adults

Inclusion criteria

• 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:

• Straining during more than 25% of defecations
• Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than 25% of defecations
• Sensation of incomplete evacuation more than 25% of defecations
• Sensation of anorectal obstruction/blockage more than 25% of defecations
• Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
• Fewer than three SBM per week ii Loose stools are rarely present without the use of laxatives iii. Insufficient criteria for irritable bowel syndrome.
• Able to complete the study according to the requirements of the trial protocol;
• Patients who have signed the informed consent form;
• 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

• The use of probiotics, prebiotics, or antibiotics within 2 weeks of enrollment.
• Regular use of a high-fiber diet, as measured by the recommended food score (RFS);
• Regular use of medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
• 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.
• Medical history of cardiovascular, liver, or renal diseases; alcoholics.
• Hypersensitivity to probiotics or the ingredients used in this study.
• Pregnancy or breastfeeding.
• Participation in another clinical trial in the 3 months before enrollment. All participants provided written informed consent. -