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CompletedNCT06020365FMT-CIPUpdated Aug 31, 2023

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

An interventional study of sequential fecal microbiota transplant combined with small intestinal fluid transplant in Intestinal Pseudo-Obstruction and Fecal Microbiota Transplantation, sponsored by Shanghai 10th People's Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2023-08-31.

Sponsored by Shanghai 10th People's Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 5 years 7 months after the study started (first participant enrolled Jan 2018, registered Aug 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Intestinal Pseudo-Obstruction
  • Fecal Microbiota Transplantation
03

In context

Intestinal Pseudo-Obstruction

26 studies on the registry are indexed under Intestinal Pseudo-Obstruction; 9 are open to participants now.

This study's enrollment of 10 is below the median of 61 across 18 interventional studies indexed under Intestinal Pseudo-Obstruction.

Browse Intestinal Pseudo-Obstruction studies →

Lead sponsor

Shanghai 10th People's Hospital is the lead sponsor of 167 studies on the registry; 45 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    sequential antibiotics treatment and fecal + small intestinal microbiota transplant

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

Interventions

  • Othersequential 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.

06

What researchers measure

Primary outcomes

  1. Enteral Nutrition Tolerance

    the maximal amount of enteral nutrition allowed daily

    Time frame: 8 weeks

Secondary outcomes

  1. Nutrition Status

    intersectional muscle and fat area measurements by quantitative computed tomography

    Time frame: 52 weeks

Other outcomes

  1. Need for surgery

    Surgical interventions are performed due to intestinal nutritional intolerance, including procedures such as nutritional ostomy, decompression ostomy, and intestinal resection.

    Time frame: 52 weeks

  2. Changes of both colerectal and small intestinal microbiota profile

    Both colorectal and small intestinal bacteria profile before and after treatment.

    Time frame: 8 weeks

07

Study locations

1 site
  • Shanghai Tenth People's Hospital
    Shanghai, China
08

References and documents

Individual participant data

Plan to share: Yes

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 31, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06020365
Lead sponsor
Shanghai 10th People's Hospital
Responsible party
Huanlong Qin (Dean of the hospital, Shanghai 10th People's Hospital) — Principal investigator
First posted
Aug 31, 2023
Start date
Jan 1, 2018
Primary completion
Aug 1, 2023
Completion
Aug 1, 2023
Last update
Aug 31, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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