Functional constipation
Conditions
Interventions
Placebo group:placebo
Test group:Heat-treated fermented milk (postbiotics)
Sponsors
China Agricultural University
Eligibility
Sex/Gender
All
Age
45 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age:45-75 years old; 2.BMI:18.5-34.9 kg/m2; 3. Meets the Rome IV diagnostic criteria for constipation; Must include 2 or more of the following: a. More than 1/4 (25%) of bowel movements are dry balls or hard stools (Bristol Fecal Characteristics Scale 1-2) b. More than 1/4 (25%) of cases have incomplete bowel movements c. More than 1/4 (25%) of bowel movements have anorectal obstruction/blockage sensation d. More than 1/4 (25%) of bowel movements require manual assistance (such as finger assisted defecation, pelvic floor support) e. Spontaneous bowel movements (SBM) less than 3 times per week When not using laxatives, there is rarely loose stool The symptoms before diagnosis have been present for at least 6 months and have met the above diagnostic criteria in the past 3 months. 4. Voluntarily participate in this experiment and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Have serious gastrointestinal diseases (gastric or duodenal ulcers, acute enteritis, ulcerative colitis) or significant organic lesions (colon cancer, tumors, etc.); 2. Suffering from type 1 diabetes, Parkinson's disease or any disease requiring chronic treatment; 3. Two weeks prior to the experiment, use H2 receptor antagonists, proton pump inhibitors (CPPI), or consume probiotic or prebiotic preparations; 4. Use any of the following medications three days before randomization:; a. Prokinetic agents (Tegaserod, Domperidone, Cisapride, Metoclopramide, Erythromycin) b. Containing opiate drugs c. Antispasmodic agents (atropine, hyoscyamine, scopolamine, glycopyrrolate) d. Chronic nonsteroidal anti-inflammatory drugs (NSAIDs) e. Antibiotics and laxatives; 5. Excessive smoking and drinking; 6. Women who are pregnant, breastfeeding, or planning to become pregnant within the next 6 months; 7. Allergic to milk and soybeans.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Whole gut transit time;Number of spontaneous bowel movement;Number of complete spontaneous bowel movement; | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient Assessment of Constipation symptom;Patient Assessment of Constipation Quality Of Life;Chronic Constipation Severity Rating Scale;Bristol Stool Form Scale;Perceived Stress Scale;Depression Anxiety Stress Scale;Pittsburgh Sleep Quality Index;Neurotransmitter;Inflammatory cytokines;Gut microbiota;Gut microbial metabolites; | — |
Countries
China
Contacts
Public ContactJingjing He
China Agricultural University
Outcome results
None listed