Transplantation of Anaerobic Cultured Human Intestinal Microbiota in Irritable Bowel Syndrome

Summary

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).

Timeline

Start

2015-01

Primary completion

2018-12

Completion

2018-12

Publications

• Results Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.
• Results Lewis SJ, Heaton KW. Stool form scale as a useful guide to intestinal transit time. Scand J Gastroenterol. 1997 Sep;32(9):920-4. doi: 10.3109/00365529709011203.
• Results Smits LP, Bouter KE, de Vos WM, Borody TJ, Nieuwdorp M. Therapeutic potential of fecal microbiota transplantation. Gastroenterology. 2013 Nov;145(5):946-53. doi: 10.1053/j.gastro.2013.08.058. Epub 2013 Sep 7.
• Benno P, Norin E, Midtvedt T, Hellstrom PM. Therapeutic potential of an anaerobic cultured human intestinal microbiota, ACHIM, for treatment of IBS. Best Pract Res Clin Gastroenterol. 2019 Jun-Aug;40-41:101607. doi: 10.1016/j.bpg.2019.03.003. Epub 2019 Apr 29.

Drugs

Indications