Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome (ACHIM2)
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome|
- Symptom relief according to irritable bowel syndrome-symptom severity scale (IBS-SSS) [ Time Frame: 4 weeks ]
- Differential bacterial species population as defined by 16S RNA [ Time Frame: 4 weeks ]Description of different bacterial species harboring in fecal samples before and after treatment with ACHIM. Exploratory outcome measure.
- Normalization of stool consistency as determined by the Bristol stool scale [ Time Frame: 4 weeks ]Normalization as determined by the Bristol stool scale
|Study Start Date:||January 2015|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: Treatment arm
Only one treatment arm. Patients are allocated under disease condition and later treated with ACHIM. The post-treatment disease progression is monitored.
After an observation period of 4 weeks patients with IBS-D will be treated with ACHIM
Other Name: Anaerobic cultured human intestinal microbiota
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%.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02857257
|Contact: Peter Benno, MD, PhD||+46 705795554||Peter.Benno@endoskopienheten.se|
|Contact: Per Hellström, MD, PhD||+46 70 3727423||Per.Hellstrom@medsci.uu.se|
|Stockholm, Sweden, 11157|
|Contact: Peter Benno, MD, PhD +46 7055795554 Peter.Benno@endoskopienheten.se|
|Contact: Per Hellström, MD; PhD +46 70 3727423 Per.Hellstrom@medsci.uu.se|
|Study Director:||Per Hellström, MD, PhD||Uppsala University|