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

Primary Purpose

Intestinal Pseudo-Obstruction, Fecal Microbiota Transplantation

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
sequential fecal microbiota transplant combined with small intestinal fluid transplant
Sponsored by
Shanghai 10th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intestinal Pseudo-Obstruction

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Shanghai Tenth People's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

sequential antibiotics treatment and fecal + small intestinal microbiota transplant

Arm Description

Outcomes

Primary Outcome Measures

Enteral Nutrition Tolerance
the maximal amount of enteral nutrition allowed daily

Secondary Outcome Measures

Nutrition Status
intersectional muscle and fat area measurements by quantitative computed tomography

Full Information

First Posted
August 21, 2023
Last Updated
August 27, 2023
Sponsor
Shanghai 10th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06020365
Brief Title
Investigation of Fecal Microbiota Transplant in Chronic Intestinal Pseudo-obstruction Patients
Acronym
FMT-CIP
Official Title
Investigation of Fecal Microbiota Transplant Treatment in Chronic Intestinal Pseudo-obstruction Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
August 1, 2023 (Actual)
Study Completion Date
August 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 10th People's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intestinal Pseudo-Obstruction, Fecal Microbiota Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sequential antibiotics treatment and fecal + small intestinal microbiota transplant
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
sequential fecal microbiota transplant combined with small intestinal fluid transplant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Enteral Nutrition Tolerance
Description
the maximal amount of enteral nutrition allowed daily
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Nutrition Status
Description
intersectional muscle and fat area measurements by quantitative computed tomography
Time Frame
52 weeks
Other Pre-specified Outcome Measures:
Title
Need for surgery
Description
Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.
Time Frame
52 weeks
Title
Changes of both colerectal and small intestinal microbiota profile
Description
Both colorectal and small intestinal bacteria profile before and after treatment.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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