Faecal Microbiota Transplantation in Irritable Bowel Syndrome

Irritable Bowel Syndrome With Diarrhea Clinical Trial

— MISCEAT  

Official title:

Faecal Microbiota Transplantation in Irritable Bowel Syndrome: a Randomised, Double-blind Cross-over Study Utilising Mixed Microbiota From Healthy Donors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04899869
• Other study ID #: INT_TN_001
• Status: Completed
• Phase: N/A
• Start date: June 17, 2021
• Est. completion date: April 29, 2024

Study information

• Verified date: May 2024
• Source: Thomayer University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Irritable bowel syndrome (IBS) is the most common functional bowel disorder, being present in approximately 10% of adult Europoid population. The etiology of IBS is elusive. Literature indicates that modification of patients´colonic microbiota might ameliorate the condition. Here we test an intervention by faecal microbiota transplantation of artificially inflated microbiome diversity, versus autoclaved placebo.

Description:

Three-groups, double-blind, placebo-controlled, randomised, cross-over study in adult patients diagnosed with IBS (diarrhoeal or mixed form) according to Rome IV criteria. Each study subject will undergo two pairs of faecal microbiota transplantation (a total of four enemas for each patient), with the pairs of transfers being eight weeks apart. The active intervention substance is a mixed stool microbiota derived from healthy individuals, screened for infectious diseases according to European consensus conference on faecal microbiota transplantation guidelines, and who were preselected for high alpha diversity of their microbiome and distance in community ordination from IBS patients microbiota. Placebo is the same mixture, inactivated by autoclaving.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: April 29, 2024
• Est. primary completion date: March 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Diarrhea Predominant Irritable Bowel Syndrome (IBS-D) or Irritable Bowel Syndrome with mixed bowel habits (IBS-M) according to the Rome IV criteria

Exclusion Criteria:

• The use of antibiotics within one month prior to faecal microbiota transplantation

• The use of probiotics within one month prior to faecal microbiota transplantation

• History of inflammatory bowel disease or gastrointestinal malignancy, systemic autoimmune diseases (ongoing or in history)

• Previous abdominal surgery (other than appendectomy or cholecystectomy or hernioplasty or cesarean section)

• HIV infection or other active infection

• Renal or hepatic disease (both defined by biochemistry workup)

• Diabetes mellitus, abnormal thyroid functions not controlled by thyroid medications

• Bipolar disorder or schizophrenia (ongoing or history thereof), moderately severe depression defined by Patient Health Questionnaire-9 (PHQ-9) score > 15

• Anxiety defined by a Generalised Anxiety Disorder 7 (GAD7) score > 10

• Current pregnancy and lactation

Related Conditions & MeSH terms

• Diarrhea
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Mixed
• Irritable Bowel Syndrome With Diarrhea
• Syndrome

Intervention

Other:
• Faecal microbiota transplantation with active study microbiota first
2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
• Faecal microbiota transplantation with inactive autoclaved study microbiota first
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota
• Faecal microbiota transplantation with inactive autoclaved study microbiota only
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota

Locations

Country	Name	City	State
Czechia	Thomayer University Hospital	Prague

Sponsors (2)

Lead Sponsor	Collaborator
Thomayer University Hospital	Charles University, Czech Republic

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the IBS severity symptom score (IBS-SSS)	Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.	The difference between the score at four weeks after the intervention (study weeks 5 or 13, respectively) and the baseline score (week -1 in 'Active microbiota first' group or week 8 in 'Inactive microbiota first' group)
Secondary	The acute change in the IBS severity symptom score (IBS-SSS)	IBS-SSS between baseline and two weeks after intervention	study weeks 3 and 11, respectively
Secondary	The long-term change in the IBS severity symptom score (IBS-SSS)	IBS-SSS between baseline (week -1) and week 32. The long term change will compare placebo group to merged active study microbiota groups.	baseline and study week 32
Secondary	Change in number of loose stools per day	Change in number of loose stools per day in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in stool consistency	Change in stool consistency evaluated by Bristol stool scale (type 3 and 4 - normal; types 1,2,5,6 and 7 - abnormal) in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in abdominal pain	Change in abdominal pain measured by Visual Analogue Scale (VAS) (0 - no pain, 10 - worst pain) in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in frequency of bloating per week	Change in frequency of bloating per week (as there is no standardised measurement, it will be reported as number of episodes per time unit, where the possible answers could be: no bloating, bloating once a week, twice a week, three times a week, four times a week, five times a week, six times a week, bloating daily, bloating daily and sometimes at night, bloating more than half of days, bloating continuously) in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in Body Mass Index	Change in Body Mass Index (BMI in kg/m^2) in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in waist circumference	Change in waist circumference (in centimeters) in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in body fat mass estimated by skinfold thickness measuring	Change in body fat mass estimated by measuring combined skinfold thickness at given locations (biceps, triceps, subscapular, suprailiac) in millimetres in the active microbiota group relative to the placebo group	baseline and study week 32
Secondary	Change in body fat mass measured by bioelectrical impedance analysis	Change in body fat mass in the active microbiota group relative to the placebo group measured by bioelectrical impedance analysis (in %)	baseline and study week 32
Secondary	Change in faecal microbiome's alpha (within-sample) diversity	Change in faecal microbiome's alpha (within-sample) diversity in the active microbiota group relative to the placebo group measured by Chao index of alpha diversity (higher value means higher alpha-diversity)	baseline and study week 32
Secondary	Change in faecal microbiome's beta (between samples) diversity	Change in faecal microbiome's beta (between samples) diversity in the active microbiota group relative to the placebo group assessed by the quantitative Bray-Curtis index (more distant means more different bacterial composition) ordinated by nonmetric multidimensional scaling (NMDS)	baseline and study week 32
Secondary	Change in the quantity of single-cell protist Blastocystis	Change in the quantity of single-cell protist Blastocystis in the active microbiota group relative to the placebo group assessed by a specific quantitative polymerase chain reaction assay measured in genomic equivalents per microlitre DNA (the higher concentration means more of Blastocystis)	baseline and study week 32
Secondary	The psychological and well-being effects of the therapy (IBS-QoL)	The psychological and well-being effects of the therapy scored by IBS-QoL questionnaires	baseline and study week 32