Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases

Inflammatory Bowel Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01793831
• Other study ID #: FMC-CN-121101
• Status: Recruiting
• Phase: N/A
• Start date: February 2013
• Est. completion date: December 2025

Study information

• Verified date: April 2024
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang, MD,PhD
• Phone: 086-25-58509883
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 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 is an initial step into investigating the potential efficacy of fecal bacteriotherapy for CD, the investigators propose to determine the efficiency, durability and safety of FMT in a series of 500 patients with CD in ten years.

Description:

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. Then the microbiota is transplanted to mid-gut (at least below the duodenal papilla) through regular gastroscope. Patients from multi-clinical centers in this study will be assigned to receive FMT only once or traditional treatments according to associated guidelines and follow-up for at least one year. Blood tests, abdominal X-ray, endoscopy and questionnaire will be used to assess participants at study start and at study completion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 80 Years

Eligibility

Inclusion Criteria:

patients who had been diagnosed with CD through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, patients with inactive and active CD and patients who failed to achieve satisfactory efficacy for CD from the previous therapies.

Exclusion Criteria:

Patients were excluded if accompanied by other severe diseases, including other intestinal diseases (e.g., Clostridioides difficile infection), malignant neoplasm, cardiopulmonary failure, and serious liver and kidney disease, refused to complete the follow-up, and underwent FMT or WMT before.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Diseases
• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Procedure:
• FMT
Standard FMT

Locations

Country	Name	City	State
China	Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University	Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

References & Publications (6)

Aroniadis OC, Brandt LJ. Fecal microbiota transplantation: past, present and future. Curr Opin Gastroenterol. 2013 Jan;29(1):79-84. doi: 10.1097/MOG.0b013e32835a4b3e. — View Citation

Cui B, Feng Q, Wang H, Wang M, Peng Z, Li P, Huang G, Liu Z, Wu P, Fan Z, Ji G, Wang X, Wu K, Fan D, Zhang F. Fecal microbiota transplantation through mid-gut for refractory Crohn's disease: safety, feasibility, and efficacy trial results. J Gastroenterol — View Citation

Damman CJ, Miller SI, Surawicz CM, Zisman TL. The microbiome and inflammatory bowel disease: is there a therapeutic role for fecal microbiota transplantation? Am J Gastroenterol. 2012 Oct;107(10):1452-9. doi: 10.1038/ajg.2012.93. — View Citation

He Z, Li P, Zhu J, Cui B, Xu L, Xiang J, Zhang T, Long C, Huang G, Ji G, Nie Y, Wu K, Fan D, Zhang F. Multiple fresh fecal microbiota transplants induces and maintains clinical remission in Crohn's disease complicated with inflammatory mass. Sci Rep. 2017 — View Citation

Zhang FM, Wang HG, Wang M, Cui BT, Fan ZN, Ji GZ. Fecal microbiota transplantation for severe enterocolonic fistulizing Crohn's disease. World J Gastroenterol. 2013 Nov 7;19(41):7213-6. doi: 10.3748/wjg.v19.i41.7213. — View Citation

Zhang T, Xiang J, Cui B, He Z, Li P, Chen H, Xu L, Ji G, Nie Y, Wu K, Fan D, Huang G, Bai J, Zhang F. Cost-effectiveness analysis of fecal microbiota transplantation for inflammatory bowel disease. Oncotarget. 2017 Oct 4;8(51):88894-88903. doi: 10.18632/o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical remission	Clinical remission defined as HBI score ? 4. The endpoint of follow-up is the time of clinical recurrence.	Up to one year
Secondary	Costs	Social and medical costs	Up to one year
Secondary	Adverse events	All possible adverse events:fever,abdominal pain,infectious diseases and others	During FMT and ten years after FMT
Secondary	sleep quality	evaluated by PSQI and ISI	before FMT, 1 month after FMT, 12 weeks after FMT
Secondary	fatigue	evaluated by FACIT-F	before FMT, 1 month after FMT, 12 weeks after FMT
Secondary	anxiety and depression	evaluated by HADS	before FMT, 1 month after FMT, 12 weeks after FMT