Faecal Microbiota Transplantation in Patients With Microscopic Colitis

NCT03275467 | Completed

• 1 other identifier: 2017/072
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested. In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.

Conditions

Microscopic Colitis

Outcome Measures

Primary Outcomes (1)

• Proportion of MC patients in remission six weeks after the first FMT.

  Remission is defined as \<3 stools per day and a mean of less than one watery stool per day.

  6 weeks

Secondary Outcomes (10)

• Changes in general health and symptom questionnaire scores

  6 weeks, 8 weeks, 12 weeks, 6 months

• Changes in general health questionnaire scores

  6 weeks, 8 weeks, 12 weeks, 6 months

• Changes in quality of life questionnaire scores

  6 weeks, 8 weeks, 12 weeks, 6 months

• Changes in gastrointestinal symptom questionnaire scores

  6 weeks, 8 weeks, 12 weeks, 6 months

• Changes in hospital and anxiety depression scores

  6 weeks, 8 weeks, 12 weeks, 6 months

Other Outcomes (7)

• Changes in inflammation markers in faecal samples such as faecal calprotectin

  6 weeks, 8 weeks, 12 weeks, 6 months

• Changes in metabolite profile in faecal samples and blood

  faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; blood: 6 weeks

• Changes in gene expression in mucosal biopsies

  6 weeks

Study Arms (1)

Faecal microbiota transfer (FMT)

EXPERIMENTAL

Suspended stool from a healthy donor

Other: Faecal microbiota transfer (FMT)

Interventions

Faecal microbiota transfer (FMT) OTHER

Suspended stool from a healthy donor

Faecal microbiota transfer (FMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent
• Active MC diagnosis, defined as \>3 stools a day from which at least one should be watery
• Willingness to stop budesonide treatment during participation in the trial
• Age: 18-70 years

You may not qualify if:

• Previous complicated gastrointestinal surgery
• Malignant disease except non-melanoma skin cancer
• Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
• C. difficile or other current gastroenteritis
• Females who are pregnant or breast-feeding
• Severe endometriosis
• Antimicrobial treatment 4 weeks prior to first screening visit
• Antimicrobial prophylaxis (eg. acne, urinary tract infection)
• Regular consumption of probiotic products 4 weeks prior to randomization
• Recently diagnosed lactose intolerance (less than 6 months prior to first screening visit)
• Recently diagnosed coeliac disease (less than 6 months prior to first screening visit)
• Regular intake of NSAIDs (non steroidal anti-inflammatory drugs)
• Abuse of alcohol or drugs
• Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
• Signed informed consent

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Region Örebro County: collaborator

Study Sites (1)

University Hospital Örebro

Örebro, Örebro County, 70185, Sweden

Location

MeSH Terms

Conditions

Colitis, Microscopic

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Robert J Brummer, Professor, MD

  Örebro University, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: September 7, 2017
• Study Start: June 1, 2017
• Primary Completion: June 5, 2019
• Study Completion: October 31, 2019
• Last Updated: February 21, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)