Functional constipation
Conditions
Interventions
Intervention group: Plant-based formented milk beverage, 2 bottles per day (250 ml per bottle)
Control group: plant-based protein milk beverage, 2 bottles per day (250 ml per bottle)
Sponsors
The Second Affiliated Hospital of Xi’an Jiaotong University
Eligibility
Sex/Gender
All
Age
18 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 - 55 years old; 2. Autonomous defecation frequency per week is less than or equal to 3 times; 3. Meeting the Rome IV diagnostic criteria for functional constipation: 1) two or more of the following: * a. Straining during more than ¼ (25%) of defecations. b. Lumpy or hard stools (Bristol Stool Form Scale 1-2) more than ¼ (25%) of defecations. c. Sensation of incomplete evacuation more than ¼ (25%) of defecations. d. Sensation of anorectal obstruction/blockage more than ¼ (25%) of defecations. e. Manual maneuvers to facilitate more than ¼ (25%) of defecations (e.g., digital evacuation, support of the pelvic floor). f. Fewer than 3 spontaneous defecations per week. 2) Loose stools are rarely present without the use of laxatives. 3) Insufficient for irritable bowel syndrome. Criteria fulfilled for the last 3 months with symptom onset at least 6 months prior to diagnosis.
Exclusion criteria
Exclusion criteria: 1) Difficult in verbal expression; 2) Have severe systemic diseases such as cardiovascular, liver, kidney and hematopoietic systems; 3) Those with defecation difficulties accompanied by pain; 4) Those who have experienced acute gastrointestinal diseases within 30 days; 5) Those with other concomitant diseases under treatment; 6) Those with organic lesions (adenoma, colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.) indicated by colonoscopy within one year; 7) Pregnant or in lactation; 8) Those who have regularly taken supplements or drugs related to constipation (laxatives, dietary fiber supplements, etc.) within the recent three months, affecting the judgment of the results; 9) Those who cannot eat by mouth or take the test sample as required; 10) Other patients considered by the investigator not suitable for the study; 11) Those who do not sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| complete spontaneous bowel movement response rate;Total cholesterol;HDL-C;LDL-C; | — |
Secondary
| Measure | Time frame |
|---|---|
| Bowel movement frequency per week;Bristol stool scale score;Defecation difficulty score;Gastrointestinal Symptom Rating Scale ;Individual Assessment Score of Constipation and Related Symptoms;Score of psychological condition assessment;Glucose;Triglycerides;The diversity and abundance of intestinal flora;Pittsburgh Sleep Quality Index;Kupperman Score; | — |
Countries
China
Contacts
Public ContactXin Liu; Qian Wang
Xi’an Jiaotong University; The Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed