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

Sponsor

Shanghai 10th People's Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT06020365

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.1

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intestinal Pseudo-Obstruction Fecal Microbiota Transplantation	Other: sequential fecal microbiota transplant combined with small intestinal fluid transplant	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Actual Primary Completion Date :

Aug 1, 2023

Actual Study Completion Date :

Aug 1, 2023

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Enteral Nutrition Tolerance [8 weeks]
the maximal amount of enteral nutrition allowed daily

Secondary Outcome Measures

Nutrition Status [52 weeks]
intersectional muscle and fat area measurements by quantitative computed tomography

Other Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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;

Intervention with antibiotics during treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Shanghai Tenth People's Hospital	Shanghai		China

Sponsors and Collaborators

Shanghai 10th People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Huanlong Qin, Dean of the hospital, Shanghai 10th People's Hospital

ClinicalTrials.gov Identifier:

NCT06020365

Other Study ID Numbers:

FMT_CIPO

First Posted:

Aug 31, 2023

Last Update Posted:

Aug 31, 2023

Last Verified:

Aug 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intestinal Pseudo-Obstruction

Study Results

No Results Posted as of Aug 31, 2023