Functional Constipation
Conditions
Interventions
intervention group:Conduct a one month population intervention trial, where participants consume a probiotic product half an hour after lunch each day
placebo group:Conduct a one month population intervention trial, where participants consume a placebo product half an hour after lunch each day
Sponsors
West China School of Public Health, Sichuan University/West China Fourth Hospital
Eligibility
Sex/Gender
All
Age
50 Years to 65 Years
Inclusion criteria
Inclusion criteria: ? 50-65 years old (including both ends); ? Voluntarily continue to participate in this study and sign an informed consent form. ? According to the Rome IV diagnostic criteria for functional constipation, after excluding organic diseases causing constipation, the following two or more items must be included: a. More than 1/4 (25%) of bowel movements feel laborious b. More than 1/4 (25%) of bowel movements are dry ball feces or hard feces (Bristol Fecal Characteristics Scale 1-2 types) c. More than 1/4 (25%) of cases have incomplete bowel movements d. More than 1/4 (25%) of bowel movements have anorectal obstruction/blockage sensation e. More than 1/4 (25%) of bowel movements require manual assistance (such as finger assisted defecation, pelvic floor support) f. Spontaneous bowel movements (SBM) less than 3 times per week ? When not using laxatives, there is rarely loose stool ? Not meeting the diagnostic criteria for irritable bowel syndrome *The symptoms before diagnosis have appeared for at least 6 months and have met the above diagnostic criteria in the past 3 months **For research purposes, if a patient meets the diagnostic criteria for opioid induced constipation (OIC), they should not be diagnosed with FC because it is difficult to distinguish between the side effects of opioids and other causes of constipation. But clinical doctors should be aware that FC and opioid induced constipation can overlap
Exclusion criteria
Exclusion criteria: ? Constipation caused by organic diseases and medication factors; ? Subjects who took antibiotics, probiotics, prebiotics, and other medications within one week prior to intervention that affected the test results; ? Individuals who are unable to eat orally or take the test sample as prescribed. ? Individuals who are physically weak and unable to conduct experiments. ? Individuals who have undergone surgical procedures within 30 days and experience symptoms of constipation. ? Patients with recent difficulty in defecation caused by severe organic lesions (colon cancer, severe enteritis, intestinal obstruction, inflammatory bowel disease, etc.) ? Constipation difficulties accompanied by pain. ? Individuals who have experienced acute gastrointestinal diseases within the past 30 days. ? Patients with severe systemic diseases such as cardiovascular, liver, kidney, and hematopoietic systems. ? There are other accompanying diseases being treated. ? Other researchers believe that situations that need to be excluded. If participants have participated in other clinical trials within the past three months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete spontaneous bowel movement;gut microbiota;metabolites;anthropological measuring; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous bowel movement;Proportion of CSBMs = 3 times per week;Average score of stool morphology;Average score of difficulty in defecation;Quality of Life Score for Constipation Patients;Self evaluation score of constipation patients; | — |
Countries
China
Contacts
Public ContactCheng Ruyue
West China School of Public Health, Sichuan University/West China Fourth Hospital
Outcome results
None listed