Faecal Microbiota Transplantation (FMT) in Patients With IBSmechanism(s) of Action
キーワード
概要
説明
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 5 questionnaires and deliver fecal samples at the baseline, 2 weeks, 1 month and 3 month 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).
日付
| 最終確認済み: | 04/30/2020 |
| 最初に提出された: | 01/14/2020 |
| 提出された推定登録数: | 01/16/2020 |
| 最初の投稿: | 01/21/2020 |
| 最終更新が送信されました: | 05/19/2020 |
| 最終更新日: | 05/20/2020 |
| 実際の研究開始日: | 12/31/2019 |
| 一次完了予定日: | 12/30/2020 |
| 研究完了予定日: | 12/30/2021 |
状態または病気
介入/治療
Dietary Supplement: Feces
段階
アームグループ
| 腕 | 介入/治療 |
|---|---|
| Active Comparator: Smal intestine once 90-g fecal transplant given into the small intestine once. | |
| Active Comparator: Small intestine twice 90-g fecal transplant given into the small intestine twice with 1 week interval. | |
| Active Comparator: Large intestine once 90-g fecal transplant given into the large intestine once. |
適格基準
| 研究の対象となる年齢 | 18 Years に 18 Years |
| 研究に適格な性別 | All |
| 健康なボランティアを受け入れる | はい |
| 基準 | Inclusion Criteria: 1. Patients who fulfil Rome IV criteria for the diagnosis of IBS. 2. Patients were investigated to exclude other gastrointestinal organic cause(s). 3. Moderate-to-severe IBS symptoms, as indicated by a score of ≥175 on the IBS Severity Scoring System (IBS-SSS). Exclusion Criteria: 1. Pregnant or lactating women. 2. The use of antibiotics or probiotics within 1 month prior to FMT. 3. Immunocompromised patients defined as those treated by immune- suppressive medications. 4. Patients with co-morbidity such as kidney failure or chronic heart disease. 5. System disease such as diabetes. 6. Patients with serious psychiatric disorders or drug abuse. |
結果
主な結果の測定
1. Change in IBS-SSS total score [Three months after FMT]
二次的な結果の測定
1. Change in the Dysbiosis index [Three months after FMT]
