Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients

Fecal Microbiota Transplantation Clinical Trial

— FMT-CIP  

Official title:

Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06020365
• Other study ID #: FMT_CIPO
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: August 2023
• Source: Shanghai 10th People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic Intestinal Pseudo-Obstruction (CIPO) is a rare gastrointestinal disorder that primarily affects the movement of the intestines, leading to symptoms that resemble a true bowel obstruction but without a physical blockage. This condition is characterized by impaired motility of the gastrointestinal tract, which can result in severe symptoms and complications. In previous studies, the investigator found that sequential microbiota transplantation therapy can improve clinical symptoms of chronic pseudo-obstruction. Building on this foundation, the current study further investigates the effects of sequential interventions involving intestinal cleansing, small intestine bacterial treatment, fecal microbiota transplantation, and nutritional therapy on the short-term and long-term clinical symptom improvement in patients. Additionally, the investigator aim to elucidate the changes in gut microbiota phenotypes before and after treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

1. aged over 18 years old;

2. met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;

3. can tolerate nasojejunal tube and complete full course of FMT treatment;

4. the clinical data are relatively complete and there is follow-up available for evaluation

Exclusion Criteria:

1. accompanied by chronic wasting diseases such as malignant tumor and hyperthyroidism;

2. associated with gastrointestinal organic diseases such as short bowel syndrome, intestinal fistula, and inflammatory bowel disease; c) severe destruction of the intestinal mucosa, severe immunosuppression, combined with severe systemic infection; d) Intervention with antibiotics during treatment

Related Conditions & MeSH terms

• Fecal Microbiota Transplantation
• Intestinal Pseudo-Obstruction

Intervention

Other:
• sequential fecal microbiota transplant combined with small intestinal fluid transplant
for eligible patients, the investigator use rifaximin, three times daily, 0.4 g each time, lasting 6 days followed by fecal microbiota transplant combined with small intestinal fluid transplant for 6 days. These procedures were repeated every 28 days.

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Need for surgery	Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.	52 weeks
Other	Changes of both colerectal and small intestinal microbiota profile	Both colorectal and small intestinal bacteria profile before and after treatment.	8 weeks
Primary	Enteral Nutrition Tolerance	the maximal amount of enteral nutrition allowed daily	8 weeks
Secondary	Nutrition Status	intersectional muscle and fat area measurements by quantitative computed tomography	52 weeks