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NCT Number: NCT01793831

Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism. Evidence from animal and human studies strongly supports the link between intestinal bacteria and inflammatory bowel diseases (IBD). Dozens of studies reported its efficacy in treatment of severe Clostridium difficile colitis. Preliminary studies using fecal microbiota transplantation (FMT) for Ulcerative Colitis (UC), Crohn's diseases (CD), irritable bowel syndrome (IBS) and constipation have also met with some success. However, the results on CD is very limited. This marks the initial step in exploring the potential efficacy of fecal bacteriotherapy for CD. The investigators aim to evaluate the effectiveness, durability, and safety of FMT in a cohort of at least 500 patients with CD over a ten-year period

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Key information

Conditions

Inflammatory Bowel Disease Crohn's Disease (CD) Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University, Huai'an, Jiangsu, China

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About this study

The present clinical trial aims to re-establish a gut functionality state of intestinal flora through FMT as a therapy for CD (all age range,HBI>4). We established a standard microbiota isolation from donated fresh stool in lab. The microbiota is then transplanted into the intestine via endoscopy or other established methods, such as mid-gut or colonic transendoscopic enteral tubing. Patients from multi-clinical centers in this study will be assigned to receive FMT or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, imaging, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Clinical diagnosis of Crohn's disease, with the diagnosis remaining unchanged after at least three months of follow-up.

Willingness to undergo FMT (Fecal Microbiota Transplantation).

Exclusion criteria

Presence of serious conditions that made them unsuitable for inclusion (e.g., malignant neoplasms, cardiopulmonary failure, serious liver or kidney disease).

Treatment and study plan

FMT

Procedure

Standard FMT

Primary outcomes

  1. Clinical remission

    Time frame: Up to one year

    Clinical remission defined as HBI score ≦ 4. For patients with complications such as intestinal obstruction, Clinical remission can be defined as obstruction improvement. The endpoint of follow-up is the time of clinical recurrence.

Secondary outcomes

  1. Costs

    Time frame: Up to one year

    Social and medical costs

  2. Adverse events

    Time frame: During FMT and ten years after FMT

    All possible adverse events:fever,abdominal pain,infectious diseases and others

  3. Sleep quality

    Time frame: before FMT, 1 month after FMT, 12 weeks after FMT

    evaluated by Pittsburgh Sleep Quality Index (PSQI), with a score range of 0 to 21. Higher PSQI score indicates poorer sleep quality. Insomnia Severity Index (ISI), with a score range of 0 to 28. Higher ISI score indicates more severe insomnia.

  4. Fatigue

    Time frame: before FMT, 1 month after FMT, 12 weeks after FMT

    evaluated by Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), with a score range of 0 to 52. Higher FACIT-F score indicates lower levels of fatigue and better quality of life.

  5. Anxiety and depression

    Time frame: before FMT, 1 month after FMT, 12 weeks after FMT

    evaluated by Hospital Anxiety and Depression Scale (HADS), with a score range of 0 to 42. Higher scores indicate greater severity of anxiety and depression symptoms.

  6. Symptomatic stricture

    Time frame: before FMT, 1 month after FMT, 12 weeks after FMT

    evaluated by Crohn's Disease Obstruction Score (CDOS), with a score range of 0 to 6. Higher scores indicate greater severity of obstructive symptoms.

Study contacts

Contact information is provided by the study sponsor or research team.

Faming Zhang, MD, PhD

CONTACT

[email protected]

86-025-58509883

Huijie Zhang, MD, PhD

CONTACT

[email protected]

86-025-58509670

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

  • The Affiliated Huaian NO.1 People's Hospital of Nanjing Medical University
  • The First Affiliated Hospital of Air Force Medicial University

Registry information

Official study title

Efficacy and Safety of Standardized Fecal Microbiota Transplantation for Moderate to Severe Crohn&Apos;s Diseases

Important dates

Study start
2013
Primary completion
2025
Study completion
2025
First posted
Feb 18, 2013
Registry last updated
Nov 29, 2024

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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