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Clinical validation study on the efficacy of Xiaolan box probiotics in relieving constipation

Effects of probiotic intervention on functional constipation and intestinal flora in the elderly

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050228
Enrollment
Unknown
Registered
2021-08-22
Start date
2021-09-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Functional Constipation

Interventions

experimental group:Give small blue box probiotic solid beverage 6g/d and dietary physical activity guidance
control group:Give the same dietary and physical activity guidance

Sponsors

Xiangya School of Public Health, Central South University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 60 years; 2. No physical disability, serious cardiovascular disease, serious gastrointestinal disease, serious liver and kidney disease or endocrine disease; 3. Meet the diagnostic criteria of Rome IV functional constipation; 4. Have certain reading and understanding ability.

Exclusion criteria

Exclusion criteria: 1. Residence time <= 6 months; 2. Those who have undergone surgery in recent half a year; 3. Those who have used probiotics, dietary fiber or antibiotics in recent 3 months; 4. Suspected organic lesions, fever, bloody stool and black stool.

Design outcomes

Primary

MeasureTime frame
Patient Assessment of Constipation symptom;Patient Assessment of Constipation quality of life;Bristol Stool Form Scale;

Secondary

MeasureTime frame
Patient Health Questionnaire-9;Generalized Anxiety Disorder-2;Pittsburgh Sleep Quality Index;Intestinal flora structure;

Countries

China

Contacts

Public ContactLin Qian

Xiangya School of Public Health, Central South University

linqian@csu.edu.cn+86 13874820173

Outcome results

None listed

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