Gut Microbiome Transfer for the Treatment of Crohn’s Disease

Not Applicable

Withdrawn

• Conditions: Crohn's Disease; Inflammatory Bowel Disease; Oral and Gastrointestinal - Crohn's disease; Oral and Gastrointestinal - Inflammatory bowel disease

• Registration Number: ACTRN12618001590257
• Lead Sponsor: Associate Professor Justin O'Sullivan

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-25
• Last Update Posted: 24 May 2021

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Male
• Target Recruitment: 20

Inclusion Criteria

Patients
- male
- 20-50 years old
- mild to moderate Crohn's disease (HBI 5-16)

Donors
- male
- 20-50 years old
- healthy
- BMI 18.5 - 24.9 kg/m2

Exclusion Criteria

Donor exclusion criteria:
- Chronic disease
- Gastrointestinal disease (including irritable bowel syndrome, coeliac and inflammatory bowel disease)
- Any transmissible viral, bacterial, or protozoan pathogens
- Current or past history of malignancy (including gastrointestinal cancer or polyposis)
- Acute substance abuse (including tobacco, >7 standard alcoholic units/week, recreational drugs)
- Use of probiotics or antibiotics in the past 6 months
- Atopic diseases (e.g. asthma, eczema)
- Chronic pain or chronic fatigue syndromes
- Overseas travel in previous three months
- Metabolic syndrome
- First-degree relative with type 2 diabetes mellitus

Patient exclusion criteria
- Bowel complications (including abscess, phlegmon, stricture, obstruction, perforation, fistula, or infection)
- Requiring or expected to require surgery
- Major abdominal surgery in the past 3 months
- Use of antibiotics or probiotics in the past 3 months
- Acute substance abuse (including tobacco, >7 standard alcoholic units/week, recreational drugs)
- Chronic hepatitis B, C, or HIV infection
- Diabetes mellitus, cancer, or systemic lupus
- Food allergies
- Allergy to Biscodyl tablets or Glycoprep
- Swallowing dysfunction or esophageal dysmotility

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in severity of intestinal inflammation as assessed by endoscopic index score[6 weeks post-initial treatment dose [primary timepoint]<br>6 months post-initial treatment dose [secondary timepoint]]

Secondary Outcome Measures

Name	Time	Method
Change in Crohn's disease symptom severity as assessed by Harvey Bradshaw Index (HBI) score[6 weeks post-initial treatment dose<br>6 months post-initial treatment dose];Change in health-related quality of life as assessed by the short inflammatory bowel disease questionnaire (SIBDQ)[6 weeks post-initial treatment dose<br>6 months post-initial treatment dose];Explore any changes to the gut microbiome (diversity, composition and function) as assessed by metagenomic, metatranscriptomic, and metabolomic technologies[6 weeks post-initial treatment dose<br>6 months post-initial treatment dose];Explore any changes to body mass index (BMI) as assessed via anthropomorphic measurements[6 months post-initial treatment dose]