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A clinical study for the effect of the fecal microbiota transplantation on the treatment of the Irritable Bowel Syndrome combined with anxiety or depression

A clinical study for the effect of the fecal microbiota transplantation on the treatment of the Irritable Bowel Syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024924
Enrollment
Unknown
Registered
2019-08-03
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-08-27

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

Conditions

Irritabel Bowel Disease

Interventions

1:fecal microbiota transportation
2:the placebo treatment

Sponsors

PingXiang People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. the patient is diagnosed with Irritable Bowel Syndrome according to Rome IV criteria;duration >=1 year; the digestive symptoms are not alleviated with conventional therapy in the past six month; Hamilton Depression Scale (HAM-D) score 20-34 and/or Hamilton Anxiety Scale (HAM-A) score 14-28; 2. aged between 18 and 80 years; male or female; 3. the patient who voluntarily participate in this study, provide written informed consent and agree with multiple clinical follow-up is available.

Exclusion criteria

Exclusion criteria: 1. Previous abdominal surgery (except cholecystectomy or appendicectomy); 2. Infection with Human immunodeficiency virus; 3. Patients with renal diseases, with the level of serum creatinine or blood urea nitrogen are 1.5 times above ULN 4. The value of any of the following liver function tests are twice above the normal upper limit (ULN): propionate transhydrogenase, aspartic acid transaminase, alkaline phosphatase or total bilirubin; 5. Patients with thyroid dysfunction , with a decrease?outside the reference range in the level of serum sensitie thyroid-stimulating hormone and serum T4 without thyroid drug control; 6. History of mental illness (mania and schizophrenia); 7. Active Infection at the screening visit, except Clostridium Difficile infection; 8. Pregnant or breast-feeding women; 9. Usage of probiotics, prebiotics and/or antibiotics within the last 2 weeks; 10. Patients who are participating in other clinical trials at the screening visit or within 3 months, and other conditions that might interfere with the patients or study as determined by the researcher.

Design outcomes

Primary

MeasureTime frame
IBS-SSS;Hamilton anxiety scale;Hamilton depression scale;IBS-QoL;

Secondary

MeasureTime frame
Bristol stool scale;diversity and relative abundance of gut microbiota; metabolites in stool;mitabolites in serum;

Countries

China

Contacts

Public ContactLin Hao

Pingxiang People's Hospital

554794560@qq.com+86 15705918262

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026