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NCT Number: NCT06020365

Investigation of Fecal Microbiota Transplant 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.

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Key information

Conditions

Intestinal Pseudo-Obstruction Digestive System Diseases Fecal Microbiota Transplantation Gastrointestinal Diseases Ileus Intestinal Diseases Intestinal Obstruction

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai Tenth People's Hospital

Shanghai, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Enteral Nutrition Tolerance

    Time frame: 8 weeks

    the maximal amount of enteral nutrition allowed daily

Secondary outcomes

  1. Nutrition Status

    Time frame: 52 weeks

    intersectional muscle and fat area measurements by quantitative computed tomography

Other outcomes

  1. 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.

  2. Changes of both colerectal and small intestinal microbiota profile

    Time frame: 8 weeks

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

Sponsors and collaborators

Lead sponsor

Shanghai 10th People's Hospital

Other

Registry information

Official study title

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

Acronym: FMT-CIP

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
Aug 31, 2023
Registry last updated
Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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