Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03716388
• Date of registration: 21/10/2018
• Prospective Registration: Yes
• Primary sponsor: Dayanand Medical College and Hospital
• Public title: Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC
• Scientific title: Fecal Microbiota Therapy Vs 5-aminosalicylates for Induction of Remission in Newly Diagnosed Mild-moderately Active UC : a Pilot Study
• Date of first enrolment: December 1, 2018
• Target sample size: 20
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT03716388
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider).
• Phase: Phase 3

Countries of recruitment

India

Contacts

• Name: Ajit Sood, DM

• Name: Ajit Sood, DM
• Affiliation: Professor and Head Gastroenterology

• Name: Ajit Sood, DM

Key inclusion & exclusion criteria

Inclusion Criteria:

- Active UC:

1. UC diagnosed based on history of chronic (>4 weeks), inflammatory (with blood and
mucous) diarrhoea

2. Total Mayo Score 4-10, Mayo endoscopic sub-score of >1

3. Histopathology suggestive of UC

Exclusion Criteria:

- Severe UC (Total Mayo 11-12, Endoscopic Mayo Score 3)

- Uncertainty about diagnosis of UC : Infective colitis/ Indeterminate Colitis/ Crohn's
Colitis

- Associated irritable bowel syndrome (IBS)

- Past history of surgery or colorectal surgery

- Exposure to antibiotics or probiotics in the last 4 weeks

- Patients with evidence of infections like C. difficile, cytomegalovirus, HIV,
parasitic infections or extra-intestinal infections requiring antibiotics.

- Significant cardiopulmonary co-morbidities (high risk for repeated colonoscopy)

- Pregnancy

- Refusal to consent for repeated colonoscopies.

Donor

- Single donor (voluntary healthy individual) after informed consent

- Inclusion criteria for donor

- No personal or family history of UC or any other autoimmune disease or malignancy

- Screened by stool microscopy and culture for common detectable enteric pathogens
(Salmonella, Shigella, Campylobacter, Vibrio cholera, E. coli, Clostridium
difficile, Giardia lamblia and Cryptosporidium) at the start of the study and
every 4 weeks thereafter.

- Negative for antibodies against hepatitis A, C and E, hepatitis B surface antigen
(HBsAg), syphilis and human immunodeficiency virus (HIV).

- Exclusion criteria for donor

- High-risk sexual behaviors

- Communicable illnesses

- Antibiotic treatment within the past 3 months

- Intrinsic gastrointestinal illnesses such as irritable bowel syndrome,
inflammatory bowel disease, gastrointestinal malignancies or major
gastrointestinal surgical procedures

- Ongoing immune-modulator therapy for any concurrent illness

- Chronic pain syndromes

- Neurologic/neurodevelopmental disorders

- Metabolic syndrome

- Obesity (BMI >30 kg/m2)

- Malignant illnesses

- Donor's diet will be monitored with a diet diary.



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Ulcerative Colitis Chronic Moderate

Ulcerative Colitis Chronic Mild

Intervention(s)

Other: Placebo infusion

Biological: Fecal Microbiota Transplantation

Other: Placebo granules

Drug: Mesalamine Granules

Primary Outcome(s)

Clinical remission [Time Frame: Week 14]

Secondary Outcome(s)

Histological remission [Time Frame: Week 14]

Clinical response [Time Frame: Weeks 0,2,6,10,14]

Endoscopic remission [Time Frame: Week 14]

Secondary ID(s)

2018-362

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Colitis & Crohn's Foundation (India)