Standardized Fecal Microbiota Transplantation for Ulcerative Colitis

Phase 2

Recruiting

• Conditions: Bacteria; Inflammatory Bowel Disease; Ulcerative Colitis; Fecal Microbiota Transplantation; Microbiota
• Interventions: Procedure: Standardized FMT; Drug: Traditional treatments

• Registration Number: NCT01790061
• Lead Sponsor: The Second Hospital of Nanjing Medical University

Brief 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, irritable bowel syndrome (IBS) and constipation have also met with some success. This is an initial step into investigating the potential efficacy of standardized fecal bacteriotherapy through mid-gut (at least below duodenal papilla) for UC, the investigators propose to determine the efficiency and safety of FMT in a series of 500 patients with moderate to severe UC (Montreal classification).

Detailed Description

The present clinical trial aims to re-establish a gut functionality state of intestinal microbiota through FMT as a therapy for UC. Investigators established a standard bacteria isolation from donated fresh stool in lab. Then the bacteria is transplanted to mid-gut through regular gastroscope. Patients in this study will assigned to receive FMT(s) or traditional treatments according to associated guidelines and follow-up for long term. All data were recorded in China Microbiota Transplantation System.

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-09
• Study First Submitted QC: 2013-02-09
• Study First Posted: 2013-02-13
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-17
• Last Update Posted: 2024-04-19
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

Patients who had been diagnosed with UC through a combination of typical clinical symptoms, endoscopy, and histological criteria for at least 3 months, and patients who failed to achieve satisfactory efficacy for UC 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standardized FMT	Standardized FMT	endoscopy Tubing Once or repeat
Traditional treatments	Traditional treatments	Oral Tubing

Primary Outcome Measures

Name	Time	Method
Efficacy of FMT	On year	The efficacy and durability of clinical remission (days) after Fecal Microbiota Transplantation procedure.Defined as Montreal score S0 (clinical remission)

Secondary Outcome Measures

Name	Time	Method
fatigue evaluated by the Functional Assessment of Chronic Illness Therapy fatigue subscale (FACIT-F)	before FMT, 1 month and 12 weeks after FMT	FACIT-F was composed of 13 questions, each with a score of 0-4. Total score ranged from 0 to 52, with lower score suggesting greater fatigue. Fatigue remission was defined as FACIT-F score \> 40 after FMT and an increase in the FACIT-F score ≥ 4 indicated fatigue improvement according to the previous study.
sleep quality evaluated by the Insomnia Severity Index (ISI)	before FMT, 1 month and 12 weeks after FMT	Insomnia Severity Index (ISI) was used to evaluate the severity of insomnia, which was composed of 7 items. Each item scored from 0-4, with a total score ranging from 0 to 28. High scores indicated poorer sleep quality. ISI ≥ 8 was set as a subthreshold to clinical insomnia.
Adverse events	Ten years	Number and severity of adverse events
sleep quality evaluated by the Pittsburgh Sleep Quality Index (PSQI)	before FMT, 1 month and 12 weeks after FMT	Sleep quality was assessed by the Pittsburgh Sleep Quality Index (PSQI), which consisted of 19 items divided into seven components: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction.Each component received a value from 0 to 3 and the total scores ranged from 0 to 21, with higher scores indicating poorer sleep quality. Poor sleep quality was defined as total PSQI scores \> 5.
anxiety and depression evaluated by the Hospital Anxiety and Depression Scale (HADS)	before FMT, 1 month and 12 weeks after FMT	It had 14 items, 7 each for depression (HADS-D) and anxiety (HADS-A). The total scores ranged from 0 to 21 for HADS-D or HADS-A, with higher score indicating more severe depression or anxiety symptoms. A HADS-A or HADS-D score ≥ 8 was identified as a diagnostic threshold for anxiety or depression in this study.

Trial Locations

Locations (1)

Medical Center for Digestive Diseases, The Second Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China