Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional

Summary: 
      Two hundrad patients are randomized to either 90 g transplant, 90 g transplant twice with
      1week interval into the distal small intestine via working channel of a gastroscope, or to 90
      g transplant into the coecum of the colon via working channel of a colonoscope. The patients
      shall complete 5 questionnaires measuring symptoms, fatigue and quality of life and collect a
      feces sample at the baseline, and at 3, 6 and 12 months after FMT. Dysbiosis and fecal
      bacterial are determined by using 16S rRNA gene.
    

Detailed description: 
      Patients Two hundrad patients who fulfil Rome IV criteria for irritable bowel syndrome (IBS)
      shall be included in the study. All the IBS subtypes shall be included.

      Donor Investigators are going to use the same super-donor they used in their previous
      randomised double-blind, placebo-controlled study. The donor is athletic Caucasian man aging
      36 years. He is non-smoker and is completely healthy without any medication and with a BMI of
      23.5. He is not relative to any of the patients in the trial. He was borne by vaginal
      delivery and breastfeed. He was treated 3 times with antibiotics during his life. He trains 5
      times weekly an hour each time. He took regularly dietary supplements rich in proteins,
      vitamins, fibres and minerals that made his diet richer than average in these substances. He
      was screened according to the guidelines for donors for FMT. Before he was accepted as a
      donor the microbiota was analysed in a faecal sample using GA-map Dysbiosis test. The
      analysis revealed a dysbiosis index (DI)= 1, indicating normobiosysis. In addition, he had
      excess of bacteria belonging to the Firmicutes. His faeces shall be tested every third moth
      during the trial.

      Protocol

      The patients are randomized to either 90 g transplant, 90 g transplant twice with 1week
      interval into the distal small intestine, or to 90 g transplant into the coecum of the colon.
      The patients shall complete 5 questionnaires and deliver fecal samples at the baseline, and
      at 3 , 6 , and 12 months after FMT.

      Faeces collection, preparation and administration Faeces from both the donor and patients
      shall be collected and stored at - 80•. Frozen faeces shall be thawed and each 30 g is
      dissolved in 30 mL of 0.9% sterile saline. The dissolved stool administrated to the patients,
      after overnight fast, through working channel of gastroduodeno-scope in pars descendent
      duodenum distal to the papilla of Vater or to the coecum through working channel of a
      colonoscope.

      Analysis Questionnaires

        1. IBS symptom severity Scale (IBS-SSS).

        2. Birmingham Symptom scale.

        3. IBS-quality of life (IBSQo) Questionnaire.

        4. Short form of Nepean Dyspepsia Index (SF-NDI).

        5. Fatigue Assessment Scale (FAS).

      Microbiome analysis Gut microbiota analysis is performed using the Genetic analysis-mapTM
      Dysbiosis test (Genetic Analysis AS, Oslo, Norway) by algorithmically assessing faecal
      bacterial abundance and profile (dysbiosis index, DI), and potential deviation in the
      microbiome from normobiosis. GA-map test is based on faecal homogenization, mechanical
      bacterial cell disruption and automated total bacterial genomic DNA extraction using magnetic
      beads. DI is based on 54 DNA probes targeting more than 300 bacterial strains based on their
      16S rRNA sequence in seven variable regions (V3-V9). Twenty-six bacteria probes are species
      specific, 19 detect bacteria on genus level, and 9 probes detect bacteria at higher taxonomic
      levels. Probe labelling is by single nucleotide extension and hybridization to complementary
      probes coupled to magnetic beads, and signal detection by using BioCode 1000A 128-Plex
      Analyser (Applied BioCode, Santa Fe Springs, CA, USA). A DI above 2 shows a microbiota
      profile that differs from that of the normobiotic reference collection (DI 1-2:
      non-dysbiosis, DI: moderate, DI 4-5: severe dysbiosis).
    

Intervention name(s): Feces
Intervention type(s): Dietary Supplement
Intervention description(s): Feces from healthy donor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Fecal microbiota transplantation; Intestinal microbiota; Donor; Dysbiosis; Abdominal symptom; Fatigue; Quality of life