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Clinical study on the improvement of constipation, sleep disorders, humoral and cellular immunity by multi strain fermented yogurt

Clinical study on the improvement of constipation, sleep disorders, humoral and cellular immunity by multi strain fermented yogurt

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071245
Enrollment
Unknown
Registered
2023-05-09
Start date
2023-05-10
Completion date
Unknown
Last updated
2023-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

astriction

Interventions

Control group:Ordinary yogurt intervention for 28 days, 250 mL per day
Experimental group:Multi strain fermented yogurt intervention for 28 days, 250 mL per day

Sponsors

Affiliated Hospital of Jiangnan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20-50 years. 2. Meet the Rome IV criteria for functional constipation developed by American Gastroenterological Society (AGA) and officially released in 2016: (1) Two or more of the following: 1) Difficulty defecating (at least 1 out of every 4 defecations); 2) Lumpy or hard bowel movements (at least 1 out of every 4 bowel movements); 3) Lack of defecation (at least 1 out of every 4 defecation); 4) Anorectal obstruction or obstruction (at least 1 in every 4 bowel movements); 5) Manual methods are required (at least 1 out of every 4 bowel movements); 6) < 3 bowel movements per week. (2) Almost no loose stools without laxatives. (3) The basis for diagnosis of IBS is insufficient.

Exclusion criteria

Exclusion criteria: 1. Abdominal and/or intestinal surgery, except appendectomy, cholecystectomy and non-surgical treatment of hemorrhoids; 2. Intestinal obstruction by electronic colonoscopy; 3. Rectal prolapse and/or internal hemorrhoids of grade 3-4 according to AGA diagnostic criteria; 4. Use of drugs that affect intestinal motility, such as calcium antagonists, nitrates, anti-muscarinic drugs; 5. Taking high-dose stimulant laxatives (three times a week) in the past five years; 6. Diagnosed with IBS or functional abdominal pain syndrome according to Rome IV; 7. Abdominal pain was rated as grade 5 on a scale of 0-10 on the visual analog scale; 8. Severe hematochezia, anemia, emaciation or abdominal mass; 9. Patients with a history of colorectal polyps or tumors; 10. Patients with cardiovascular, endocrine or neuromuscular diseases; 11. Patients taking medications that may affect the quality of their bowel movements or sleep, such as antidepressants, spasmolytics, or opioids; 12. Pregnant and lactating patients; 13. Patients with severe diseases of the heart, brain, liver, kidney, blood system or mental illness; 14. Those who do not use interventions according to regulations; 15. Those who cannot cooperate with or tolerate treatment; 16. Have taken antibiotics in the last 1 month; 17. Patients who take yogurt for a long time.

Design outcomes

Primary

MeasureTime frame
immunoglobulin;T lymphocyte subset;intestinal flora;melatonin;

Secondary

MeasureTime frame
blood routine;oxidative stress indicators ( T-AOC, ROS, SOD, MDA, NO, CAT and GSH );inflammatory cytokines ( IL-1, IL-6, IL-10, TNF-a );lipopolysaccharide binding factor;

Countries

China

Contacts

Public ContactCao Hong

Affiliated Hospital of Jiangnan University

violet_cao@163.com+86 530 151 6179

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026