Chronic functional constipation
Conditions
Interventions
Intervention Group:provide prebiotics and whey protein formulation 10g/day
Control Group:provide placebo (maltodextrin) 10g/day
Sponsors
Huadong Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
Female
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Female adults aged 18 to 65 years old; 2. Patients with functional constipation (refer to Rome IV diagnostic criteria for functional constipation); Symptoms appeared for at least 6 months before diagnosis, and met the above diagnostic criteria in the past 3 months; 3. Sign informed consent for study participation; 4. Agree to maintain their current level of physical activity throughout the trial period; 5. Understand the nature and purpose of the study including the potential risks and side effects; 6. Be willing to comply with the study product and methods.
Exclusion criteria
Exclusion criteria: 1.Women who are pregnant, lactating, or planning to become pregnant; 2.History of abdominal surgery that, in the investigator’s judgment, may pose a risk to the participant or confound study outcomes; 3.Acute gastrointestinal disease within the past 1 month; 4.Constipation secondary to surgery within the past 1 month; 5.History of cancer (particularly gastrointestinal cancer), severe enteritis, intestinal obstruction, inflammatory bowel disease, hypothyroidism, psychiatric disorders, stroke, cardiovascular disease, liver cirrhosis, renal failure, hematologic disorders, or organic intestinal disease identified by colonoscopy or imaging; 6.Frequent abdominal pain within the past 3 months, especially when accompanied by changes in bowel habits or frequency, hematochezia, diarrhea, or unintentional weight loss; 7.Consumption of probiotics, prebiotics, dietary fiber supplements, fermented milk, or yogurt other than the study product on a daily basis within 2 weeks after screening and throughout the study period; 8.Regular use of laxatives (more than once per week) (rescue medication is permitted for intolerable symptoms during the study); 9.Regular use (as judged by the investigator) of any medications or dietary supplements known to cause constipation within 1 month prior to screening (e.g., iron, opioids, sucralfate, misoprostol, 5-HT antagonists, antacids containing magnesium, calcium, or aluminum, antidiarrheal agents, anticholinergics, calcium supplements, calcium channel blockers, tricyclic antidepressants, or nonsteroidal anti-inflammatory drugs); 10.Anticipated major changes in diet or physical activity during the study period; 11.Systemic use of corticosteroids within the past 1 month; 12.Use of antibiotics within the past 1 month; 13.Eating disorders; 14.Known intolerance or allergy to any component of the study product; 15.Inability to provide a clear medical history, significant mental status abnormalities, impaired consciousness, or cognitive dysfunction affecting the reliability of questionnaire responses; 16.History of alcohol abuse, drug use, or substance abuse; 17.Participation in another clinical study involving any investigational product within 60 days after screening; 18.Participants deemed by the investigator to be non-cooperative or non-compliant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Wexner constipation total score;Total score of Patient-Assessment of Constipation Quality of Life; | — |
Secondary
| Measure | Time frame |
|---|---|
| Dimension scores of the Wexner Constipation Scale;Dimension scores of Patient-Assessment of Constipation Quality of Life;Scores of Self - Rating Depression Scale;Scores of Self - Rating Anxiety Scale;Gut microbiota composition; | — |
Countries
China
Contacts
Public ContactJiang Wu
Huadong Hospital Affiliated to Fudan University
Outcome results
None listed