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The therapeutic effect of intestinal flora transplantation on elderly patients with functional constipation

The therapeutic effect of intestinal flora transplantation on elderly patients with functional constipation

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000033457
Enrollment
Unknown
Registered
2020-06-01
Start date
2018-11-01
Completion date
Unknown
Last updated
2020-06-08

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

Conditions

Functional constipation

Interventions

Sponsors

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) >=60 years old; 2) Functional constipation Roman III diagnostic standard; 3) Constipation after six months of combined treatment with oral drugs or biofeedback therapy; 4) No severe cardiac insufficiency (cardiac function level II or above) and basically normal liver and kidney functions; 5) At least 2 weeks after the patient received the last treatment; 6) The expected survival time is longer than 12 months; 7) Cooperate to observe adverse events and therapeutic effects; 8) Written informed consent signed by me or his legal representative; 9) No previous history of abdominal surgery; 10) Normal coagulation function.

Exclusion criteria

Exclusion criteria: 1) The patient has any doubts about the technique or has a history of other risks; 2) The patient is in the terminal stage of the disease; 3) The patients were involved in other clinical trials three months before intestinal flora transplantation; 4) Have participated in any other flora treatment before enrollment; 5) Hepatitis b, tuberculosis, syphilis, HIV positive or any infectious disease in the acute phase; 6) Cardiac function level II or above, transaminase increase more than twice the normal upper limit, renal insufficiency CKD3 or below; 7) Fever temperature above 38 degree C or clinically significant active infection; 8) Hemoglobin < 60 g/L, neutrophil absolute value < 1.5x10^9/L, PT prolonged for more than 1.5 seconds; People with severe immune deficiency; 9) Obvious cardiovascular and cerebrovascular abnormalities or heart disease with increased risk of ventricular arrhythmias as determined by the researchers; 10) Relevant clinical contraindications identified by the investigator during the trial that may affect subject compliance and/or completion of trial-related procedures.

Design outcomes

Primary

MeasureTime frame
Intestinal flora 16S rDNA sequencing;Number of independent defecation;Bristol stool form scale;Constipation assessment scale;patient assessment of constipation symptom;knowles-eccersley-scott-symptom;patient assessment of constipation quality of life questionnaire;

Secondary

MeasureTime frame
Self-rating anxiety scale;Self-rating Depression Scale;Immunological indicators;Inflammatory indicators;

Countries

China

Contacts

Public ContactXiping Ding

The First Affiliated Hospital of USTC, Division of Life Sciences and Medicine, University of Science and Technology of China

dingxipingyx@163.com+86 55162283547

Outcome results

None listed

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