Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients (FMT-CIP)

Tongji University

Status: Completed

Conditions: Intestinal Pseudo-Obstruction; Fecal Microbiota Transplantation

Treatments: Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant

Study type: Interventional

Funder types: Other

Identifiers

NCT06020365

FMT_CIPO

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

sequential antibiotics treatment and fecal + small intestinal microbiota transplant

Experimental group

Treatment:

Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant