An interventional study of Faecal microbiota transplantation with active study microbiota first and Faecal microbiota transplantation with inactive autoclaved study microbiota first in Irritable Bowel Syndrome With Diarrhea and Irritable Bowel Syndrome Mixed, sponsored by Thomayer University Hospital. Completed at 1 site in Czechia. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-05-24.
Sponsored by Thomayer University Hospital · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 61 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →Thomayer University Hospital is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Patients will first receive two enemas of active study microbiota mixture (deep-frozen stored stool microbiota mixed from eight donors in order to increase its diversity), then after eight weeks they will receive two enemas with placebo.
Other: Faecal microbiota transplantation with active study microbiota first
Patients will first receive placebo, then the active study microbiota mixture.
Other: Faecal microbiota transplantation with inactive autoclaved study microbiota first
Patients will receive similarly timed enemas with placebos only.
Other: Faecal microbiota transplantation with inactive autoclaved study microbiota only
2x enema with active study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with active study microbiota
2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota
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.
Time frame: 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)
The acute change in the IBS severity symptom score (IBS-SSS)
IBS-SSS between baseline and two weeks after intervention
Time frame: study weeks 3 and 11, respectively
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.
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
Change in waist circumference
Change in waist circumference (in centimeters) in the active microbiota group relative to the placebo group
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
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 %)
Time frame: baseline and study week 32
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)
Time frame: baseline and study week 32
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)
Time frame: baseline and study week 32
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)
Time frame: baseline and study week 32
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
Time frame: baseline and study week 32
Plan to share: Yes — Only the researchers involved in the study have access to the final study dataset (IBS-SSS, frequency of urgent defecations, Bristol stool scale, abdominal pain and bloating), which will be shared in an anonymised form via the Zenodo repository.
Supporting information: Study protocol, Icf, Csr
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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