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

Not Applicable

Completed

• Conditions: Intestinal Pseudo-Obstruction; Fecal Microbiota Transplantation
• Interventions: Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant

• Registration Number: NCT06020365
• Lead Sponsor: Shanghai 10th People's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-01
• Status Verified: 2023-08
• Primary Completion: 2023-08-01
• Study Completion: 2023-08-01
• Study First Submitted: 2023-08-21
• Study First Submitted QC: 2023-08-27
• Last Update Submitted: 2023-08-27
• Study First Posted: 2023-08-31
• Last Update Posted: 2023-08-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sequential antibiotics treatment and fecal + small intestinal microbiota transplant	sequential fecal microbiota transplant combined with small intestinal fluid transplant	-

Primary Outcome Measures

Name	Time	Method
Enteral Nutrition Tolerance	8 weeks	the maximal amount of enteral nutrition allowed daily

Secondary Outcome Measures

Name	Time	Method
Nutrition Status	52 weeks	intersectional muscle and fat area measurements by quantitative computed tomography

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, China