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

August 27, 2023 updated by: Huanlong Qin, Shanghai 10th People's Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China
        • Shanghai Tenth People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sequential antibiotics treatment and fecal + small intestinal microbiota transplant
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enteral Nutrition Tolerance
Time Frame: 8 weeks
the maximal amount of enteral nutrition allowed daily
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nutrition Status
Time Frame: 52 weeks
intersectional muscle and fat area measurements by quantitative computed tomography
52 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Need for surgery
Time Frame: 52 weeks
Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.
52 weeks
Changes of both colerectal and small intestinal microbiota profile
Time Frame: 8 weeks
Both colorectal and small intestinal bacteria profile before and after treatment.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai 10th People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 1, 2023

Study Completion (Actual)

August 1, 2023

Study Registration Dates

First Submitted

August 21, 2023

First Submitted That Met QC Criteria

August 27, 2023

First Posted (Actual)

August 31, 2023

Study Record Updates

Last Update Posted (Actual)

August 31, 2023

Last Update Submitted That Met QC Criteria

August 27, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMT_CIPO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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