Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Study Overview
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Brief Summary
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Patients with irritable bowel syndrome (IBS) are treated with microbiota from a human intestinal anaerobic sample cultured for decades. Patients are recruited consecutively with symptoms of IBS and serve as their own controls. After an observation time of 4 weeks, patients are recruited for a 1-week run-in and then given the cultured fecal microbiota by the duodenal route via gastroscopy. Two treatments are given within a 1-week interval. Assessment of symptoms are made before and 4 weeks after the last treatment (at 6 weeks). Additionally, fecal samples are collected for bacterial 16S ribosomal ribonucleic acid (rRNA) analysis and bacterial functional parameters (microflora-associated characteristics).

Detailed Description
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Diarrhea-dominated irritable bowel syndrome (IBS-D) is studied in subjects by treatment with an anaerobic human intestinal microbiota cultured for 15 years and quality controlled with a specified content of bacterial species regularly over the years. Inclusion criteria is: Diarrheal disease since at least 4 weeks, 18-80 years of age, previously unsuccessful treatment with no symptomatic relief of antidiarrheals or resins, and signed informed consent. Primary outcome was irritable bowel syndrome-symptom severity scale (IBS-SSS). Secondary outcome was Bristol stool scale (BSS). Secondary outcome: Changes in fecal microflora distribution and multiplicity as shown by the 16S ribosomal ribonucleic acid (rRNA) analysis of feces. Once eligible for the study, patients were monitored for a run-in period of one week with the IBS-SSS and the BSS plus fecal samples for analysis of bacterial species using the bacterial specific 16S rRNA differentiation. Then, the anaerobic cultured human intestinal microflora (ACHIM) was given twice with an interval of 1 week. Thereafter, patients were further monitored over 4 weeks as regards IBS-SSS and BSS. Another feces sample was also collected for bacterial 16S rRNA analysis to evaluate the microbiota diversity. The study will be evaluated using eligible subjects as their own controls by means of Wilcoxon's matched-pairs test, alternatively t-test for matched pairs. Power analysis show that 40 subjects are needed to study in order to achieve a power of 80%.

Official Title
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Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Conditions
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Irritable Bowel Syndrome

Intervention / Treatment
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* Biological: ACHIM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: IBS according to the Rome III criteria Exclusion Criteria: Pregnancy Antibiotic and probiotics within 8 weeks before inclusion Unable to give informed consent Immunodeficiency (drug- och disease-related)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment arm<br>Only one treatment arm. Patients are allocated under disease condition and later treated with ACHIM. The post-treatment disease progression is monitored. | Biological: ACHIM<br>* After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM<br>* Other names: Anaerobic cultured human intestinal microbiota;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS) |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differential bacterial species population as defined by 16S RNA | Description of different bacterial species harboring in fecal samples before and after treatment with ACHIM. Exploratory outcome measure. | 4 weeks | 
| Normalization of stool consistency as determined by the Bristol stool scale | Normalization as determined by the Bristol stool scale | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBS, Microbiota