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

NCT06020365 | Completed

• 1 other identifier: FMT_CIPO
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Intestinal Pseudo-Obstruction; Fecal Microbiota Transplantation

Outcome Measures

Primary Outcomes (1)

• Enteral Nutrition Tolerance

  the maximal amount of enteral nutrition allowed daily

  8 weeks

Secondary Outcomes (1)

• Nutrition Status

  52 weeks

Other Outcomes (2)

• Need for surgery

  52 weeks

• Changes of both colerectal and small intestinal microbiota profile

  8 weeks

Study Arms (1)

sequential antibiotics treatment and fecal + small intestinal microbiota transplant

EXPERIMENTAL

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

Interventions

sequential fecal microbiota transplant combined with small intestinal fluid transplant OTHER

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.

sequential antibiotics treatment and fecal + small intestinal microbiota transplant

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• aged over 18 years old;
• met the current diagnosis criteria for Chronic Intestinal Pseudo-obstruction;
• can tolerate nasojejunal tube and complete full course of FMT treatment;
• the clinical data are relatively complete and there is follow-up available for evaluation

You may not qualify if:

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

Sponsors & Collaborators

• Shanghai 10th People's Hospital: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

Location

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dean of the hospital

Study Record Dates

• First Submitted: August 21, 2023
• First Posted: August 31, 2023
• Study Start: January 1, 2018
• Primary Completion: August 1, 2023
• Study Completion: August 1, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)