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A multicenter randomized controlled clinical study of intestinal feacal microbiota transplantation in the treatment of functional constipation in elderly patients

A multicenter randomized controlled clinical study of intestinal feacal microbiota transplantation in the treatment of functional constipation in elderly patients

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078433
Enrollment
Unknown
Registered
2023-12-08
Start date
2023-12-10
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Senile functional constipation

Interventions

Experimental group:FMT via colonoscopy
Control group:Placebo saline was sprayed via colonoscopy

Sponsors

The First Medical Center of Chinese PLA General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
60 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Refractory elderly patients with FC who are older than 60 and younger than 85 years old and who have not responded to traditional treatments such as laxatives and mototropic drugs after lifestyle and diet adjustment, as well as enema or biofeedback and other oral drugs, meet the diagnostic criteria of FC Rome IV, and the organic lesions of the digestive tract are excluded by examination before treatment; 2) Voluntarily undergo colonoscopy and FMT treatment; 3) Patients and their families give informed consent and sign informed consent forms.

Exclusion criteria

Exclusion criteria: 1) Organic diseases and other types of constipation related to drugs; 2) Malignant tumors of digestive tract and other organic diseases of digestive tract; 3) Previous history of abdominal and perianal surgery; 4) Recent history of gastrointestinal infection; 5) Use of antibiotics, microecological regulators and other drugs affecting intestinal microecology in the past 2 weeks; 6) Patients with severe liver and kidney, cardiovascular and cerebrovascular diseases and respiratory system diseases, unable to tolerate colonoscopy or FMT, such as acute cerebral infarction, cerebral hemorrhage and other neurological diseases, acute coronary syndrome and arrhythmia and other serious heart diseases, severe lung and liver and kidney diseases, and other systemic malignancies; 7) Have a history of neuropsychiatric system; 8) A long history of smoking and/or alcohol abuse; 9) Other contraindications for colonoscopy and FMT.

Design outcomes

Primary

MeasureTime frame
Clinical cure rate and clinical remission rate;Bristol fecal trait score;

Secondary

MeasureTime frame
Wexner constipation score;PAC-QOL;PHQ-9;GAD-7;Changes in gut microbiome structure, function, and metabolites;

Countries

China

Contacts

Public ContactWang Zikai

The First Medical Center of Chinese PLA General Hospital

wangzikai301@126.com+86 150 1157 8190

Outcome results

None listed

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