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Study on efficacy of synbiotics in improving constipation in the elderly

Efficacy of probiotics combined with their synbiotics in improving constipation in the elderly

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300077723
Enrollment
Unknown
Registered
2023-11-17
Start date
2023-11-17
Completion date
Unknown
Last updated
2023-11-21

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

Conditions

Constipation in the elderly

Interventions

placebo group:placebo

Sponsors

Chinese PLA General Hosptial
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1) age =60 years; 2) BMI18.5-34.9 Kg/m2; 3) met the Roman criteria for IV constipation; ? must include 2 or more of the following: A. More than 1/4(25%) defecate with difficulty B. More than 1/4(25%) of the patients had dry or hard stools (Bristol Type 1-2) . C.More than 1/4(25%) of bowel movements were unsatisfactory. D.More than 1/4(25%) defecates had anorectal obstruction or obstruction. E.More than 1/4(25%) of defecation requires manual assistance (e. g. , finger-assisted defecation, pelvic floor support) . F.Spontaneous bowel movement (SBM) occurred less than 3 times per week ? rare feces without laxative ? pre-diagnosis symptoms occurred at least 6 months, nearly 3 months in line with the above diagnostic criteria. 4) volunteer to participate in the trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1) suffering from colorectal cancer, colorectal or anal stenosis, rectal mass or rectal overload, false intestinal obstruction, rectal giant, or other serious gastrointestinal diseases (gastric or duodenal ulcer, acute enteritis, ulcerative colitis, etc.) ; 2)history of major operations on the digestive system (such as gastrectomy, gastrointestinal suture, enterectomy, etc.); 3)suffering from severe cerebrovascular disease, neurological disease, endocrine/metabolic disease or infectious disease; 4)use of the following drugs within 1 month (enhancers, H2 receptor antagonist, Proton-pump inhibitor, anticonvulsants, opioid, chronic non-steroidal anti-inflammatory drug, antibiotics) ; 5)regular consumption of probiotics, probiotics, such as yoghurt, probiotic powder; 6) significant abnormality in blood pressureblood pressure, severe anemia; 7) excessive smoking, frequent alcohol abuse; 8) participation in other clinical studies within 1 month; 9) other conditions deemed inappropriate for participation in this study by the principal investigator.

Design outcomes

Primary

MeasureTime frame
Number of spontaneous bowel movements per week;

Secondary

MeasureTime frame
Whole bowel transit time;Bristol Total Stool Trait Score;Total Constipation Symptom Score for Constipated Patients;Quality of Survival Scale for Constipated Patients;Cleveland Constipation Score;Intestinal metabolites;gut flora;Inflammatory cytokines;haematological metabolomics;

Countries

China

Contacts

Public ContactYinghua Liu

Chinese PLA General Hosptial

liuyinghua77@163.com+86 138 1014 8419

Outcome results

None listed

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