Skip to content

Clinical Study on the Therapeutic Value of Selective Fecal Bacteria Transplantation in Patients with Irritable Bowel Syndrome

A Randomized Controlled Clinical Study of Precision Transplantation Capsules, Intestinal Bacteria Transplantation Capsules and Probiotics in the Treatment of Irritable Bowel Syndrome

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100043160
Enrollment
Unknown
Registered
2021-02-07
Start date
2021-02-19
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

irritable bowel syndrome

Interventions

JZ group:Treat with Precision transplantation capsule (diarrhea type)
FJ group:Treat with Intestinal bacteria transplant capsule
KC group:Treated with Bacillus subtilis capsules

Sponsors

Army Medical Center of PLA
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: A. Male or female, aged 18 ~ 75 years. B. Patients who meet the diagnostic criteria of Rome IV of Irritable Bowel Syndrome and are definitely diagnosed as IBS-D. C. IBS has been diagnosed for more than 6 months, and has been treated with conventional drugs without obvious curative effect or repeated attacks. D. No mental disorders, and normal communication skills. E. Sign informed consent and agree to participate in this study. F. No antibiotics and probiotics were used within one month.

Exclusion criteria

Exclusion criteria: A. Other serious diseases of heart, liver, kidney, respiration, digestion, blood and endocrine system. B. Combined with intestinal double infection, such as CDI, enterohemorrhagic Escherichia coli, Salmonella, Shigella, Campylobacter, plague, cytomegalovirus, etc. C. Liver function is significantly abnormal or has the following history of liver disease: AST or ALT is higher than 2 times of the upper limit of normal value, history of liver cirrhosis and hepatic encephalopathy, history of esophageal varices or history of portal shunt. D. There is evidence of renal function damage or the following history of kidney disease: serum creatinine is 1.5 times higher than the upper limit of normal value; History of dialysis; Or a history of nephrotic syndrome. E. Patients with various acute infections, tumors, severe arrhythmia, mental system disorders, and drug or alcohol addicts. F. History of abdominal surgery (except appendicitis, cholecystitis, caesarean section and hysterectomy). G. Those who were allergic to capsule drugs or contraindications. H. Lactose intolerance. I. Clinical researchers who are engaged in other related irritable bowel syndrome at the time of enrollment or within 3 months before enrollment. J. It is difficult to complete the follow-up, or various factors affecting the compliance. K. Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
IBS-SSS;

Secondary

MeasureTime frame
GSRS;IBS-QoL;PHQ-9;GAD-7;SAS;SDS;Intestinal flora;

Countries

China

Contacts

Public ContactWei Yanling

Army Medical Center of PLA

lingzi016@126.com+86 15310354666

Outcome results

None listed

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