Functional constipation
Conditions
Interventions
Intervention group 1:WONDERLAB Probiotic Complex Products
Intervention group 2:Lactobacillus reuteri GOLDGUT-LR99
Intervention group 3:Lactobacillus rhamnosus GOLDGUT-M520
Intervention group 4:Maltodextrin
Sponsors
Hainan Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Male or female volunteers, 18 to 45 years of age, with a diagnosis of functional constipation based on Rome IV criteria; Must include 2 or more of the following: (1). More than 1/4 (25%) of bowel movements are laboured; (2). 1/4 (25%) or more of the bowel movements are dry bulbous stools or hard stools (Bristol Stool Trait Scale type 1 to 2); (3). 1/4 (25%) or more of the bowel movements feel incomplete; (4). 1/4 (25%) or more of the bowel movements have a sense of anorectal obstruction/blockage; (5). More than 1/4 (25%) require manual assistance for defecation (e.g., finger-assisted defecation, pelvic floor support); (6). Spontaneous defecation less than 3 times per week; Note: Symptoms have been present for at least 6 months prior to diagnosis and the above diagnostic criteria have been met for the last 3 months. 2. For the duration of the trial, participants agree not to take any medications (laxatives, antidiarrhoeal medications, etc., see exclusion criterion 6 for details), other probiotic/bacterial medications, and probiotic-containing dairy products such as yoghurt, and dairy beverages, which may cause intestinal dysfunction or interfere with the assessment of trial efficacy; 3. Willingness to refrain from participating in other interventional clinical studies while participating in the trial; 4. If a woman of childbearing potential, be contraceptive for at least one month prior to screening and commit to using contraception for the entire study period and until the time specified at the end of the study; 5. Be able to fully understand the nature and purpose of the study, the benefits to be obtained and the possible risks and side effects; 6. Be willing to comply with all trial requirements and procedures; 7. Sign the dated informed consent form.
Exclusion criteria
Exclusion criteria: 1. Severe digestive disorders such as coeliac disease, gastrointestinal bleeding, Crohn's disease, ulcerative colitis, intestinal tuberculosis, peritonitis, viral hepatitis, autoimmune liver disease, drug-induced hepatitis, cirrhosis of the liver, massive peritoneal effusion, chronic diarrhoea, irritable bowel syndrome, as well as colonic malignant tumours, congenital megacolon, intestinal adhesion, intestinal torsion, intestinal volvulus, and other disorders causing complete or incomplete intestinal obstruction; 2. Severe rectal and anal pathologies such as haemorrhoids, anal fissures, perianal abscesses, proctitis and other conditions that may cause painful bowel movements; 3. Severe systemic diseases that may affect defecation, such as malignant tumour, hypothyroidism, cerebrovascular accident, paraplegia, multiple sclerosis, dermatomyositis, systemic sclerosis, muscular dystrophy, etc; 4. Severe cardiac, hepatic, and renal insufficiency (alanine aminotransferase greater than 3 times the upper limit of the test value, blood creatinine greater than the normal value); 5. Previous history of major abdominal surgery, especially gastrointestinal surgery; 6. Morphine analogues, anticholinergics, nerve blocking agents, calcium- and aluminium-containing acidulants, laxatives, antidiarrhoeal drugs, oncological chemotherapeutic or targeted drugs, sedatives, antidepressants, anxiolytics and other psychotropic medications in the 2 months prior to intervention; 7. Long-term regular intake of probiotics, long-term use of glucocorticoids and immunosuppressants; 8. History of alcohol abuse; 9. Male or female volunteers who plan to prepare for pregnancy, or pregnant and lactating women, or those who have a planned pregnancy during the trial; 10. Allergy or lactose intolerance to probiotics or the components of any of the intervention materials used in this study; 11. Being enrolled in another clinical trial; 12. Volunteers who, in the opinion of the PI, are not able to fully co-operate or are unsuitable to participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average Number of Complete Spontaneous Bowel Movements per Week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean weekly stool pattern score;Mean weekly score for difficulty in defecation;Hospital Anxiety and Depression Scale;Pittsburgh Sleep Quality Index;Diversity of gut microbiome;Serum immunological factor;Serum gastrointestinal hormones;Serum intestinal mucosal barrier function; | — |
Countries
China
Contacts
Public ContactKaining Chen
Hainan Provincial People's Hospital
Outcome results
None listed