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NCT Number: NCT04899869

Faecal Microbiota Transplantation in Irritable Bowel Syndrome

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.

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Key information

Conditions

Irritable Bowel Syndrome With Diarrhea Irritable Bowel Syndrome Mixed

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Thomayer University Hospital

Prague, 14059, Czechia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Faecal microbiota transplantation with active study microbiota first

Other

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

Other

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

Other

2x enema with inactive autoclaved study microbiota; after 8 wks 2x enema with inactive autoclaved study microbiota

Primary outcomes

  1. Change in the IBS severity symptom score (IBS-SSS)

    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)

    Change in the IBS severity symptom score (IBS-SSS) in the active microbiota group relative to the placebo group.

Secondary outcomes

  1. The acute change in the IBS severity symptom score (IBS-SSS)

    Time frame: study weeks 3 and 11, respectively

    IBS-SSS between baseline and two weeks after intervention

  2. The long-term change in the IBS severity symptom score (IBS-SSS)

    Time frame: baseline and study week 32

    IBS-SSS between baseline (week -1) and week 32. The long term change will compare placebo group to merged active study microbiota groups.

  3. Change in number of loose stools per day

    Time frame: baseline and study week 32

    Change in number of loose stools per day in the active microbiota group relative to the placebo group

  4. Change in stool consistency

    Time frame: baseline and study week 32

    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

  5. Change in abdominal pain

    Time frame: baseline and study week 32

    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

  6. Change in frequency of bloating per week

    Time frame: baseline and study week 32

    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

  7. Change in Body Mass Index

    Time frame: baseline and study week 32

    Change in Body Mass Index (BMI in kg/m^2) in the active microbiota group relative to the placebo group

  8. Change in waist circumference

    Time frame: baseline and study week 32

    Change in waist circumference (in centimeters) in the active microbiota group relative to the placebo group

  9. Change in body fat mass estimated by skinfold thickness measuring

    Time frame: baseline and study week 32

    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

  10. Change in body fat mass measured by bioelectrical impedance analysis

    Time frame: baseline and study week 32

    Change in body fat mass in the active microbiota group relative to the placebo group measured by bioelectrical impedance analysis (in %)

  11. Change in faecal microbiome's alpha (within-sample) diversity

    Time frame: baseline and study week 32

    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)

  12. Change in faecal microbiome's beta (between samples) diversity

    Time frame: baseline and study week 32

    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)

  13. Change in the quantity of single-cell protist Blastocystis

    Time frame: baseline and study week 32

    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)

  14. The psychological and well-being effects of the therapy (IBS-QoL)

    Time frame: baseline and study week 32

    The psychological and well-being effects of the therapy scored by IBS-QoL questionnaires

Sponsors and collaborators

Lead sponsor

Thomayer University Hospital

Other

Collaborators

  • Charles University, Czech Republic

Registry information

Official study title

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

Acronym: MISCEAT

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
May 25, 2021
Registry last updated
May 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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