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A Study of the Efficacy, Safety and Mechanism of Action of Probiotics in Functional Constipation: A Randomized, Double-blind, Placebo Parallel-Controlled Trial

A Study of the Efficacy, Safety and Mechanism of Action of Probiotics in Functional Constipation: A Randomized, Double-blind, Placebo Parallel-Controlled Trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500097460
Enrollment
Unknown
Registered
2025-02-19
Start date
2024-07-08
Completion date
Unknown
Last updated
2025-10-13

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

Conditions

Functional constipation, FC

Interventions

Probiotic group:Subjects in the probiotic group were given 1 sachet of Umida probiotics twice a day Take it for 28 consecutive days.
Control group:The control group was given placebo at a dose of 1 sachet twice daily for 28 days.

Sponsors

Xuchang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meets the Rome IV diagnostic criteria for functional constipation; 2.Age 18~65 years old, gender is not limited; 3.Voluntarily participate in the study and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. History of intestinal organic diseases (inflammatory bowel disease, colon cancer, intestinal tuberculosis, intestinal obstruction, IBS, etc.); 2. Combined with serious cardiovascular and cerebrovascular diseases, malignant tumors, autoimmune diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism), or liver and kidney-related diseases; 3. Those who have had acute gastrointestinal diseases or undergone surgery within 1 month that caused constipation symptoms; 4. Laboratory examination meets the following standards: blood routine: hemoglobin <90g/L, neutrophil count <1.5×10^9/L, platelet count < 90×10^9/L. Liver function: alanine aminotransferase, aspartate 5. Transaminase exceeded 2.5 times the upper limit of normal value, and total bilirubin exceeded 1.5 times the upper limit of normal value. Renal function: Serum creatinine greater than 1.5 times the upper limit of normal. Coagulation function: activated partial thromboplastin 6. Time exceeds 1.5 times the upper limit of normal value; 7. Have taken antibiotics and probiotic preparations in the past 2 weeks; 8. Taking anti-anxiety, anti-depressant and other psychotropic drugs in the past 1 month; 9. Pregnant, lactating women, or those who have planned to become pregnant in the past 3 months; 10. Need to take drugs to improve constipation for a long time; 11. Have major mental illness, difficulty in controlling one's own actions, and unable to cooperate with research; 12. Allergic to test food ingredients; 13. Other conditions that the investigator believes are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Complete spontaneous bowel movement,CSBMs;

Secondary

MeasureTime frame
Spontaneous bowel movement;Number of spontaneous bowel movements per week;

Countries

China

Contacts

Public ContactZhiyong Zhang

Xuchang People's Hospital

zhzhy80@163.com+86 186 3972 6977

Outcome results

None listed

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