More patients with limited cutaneous systemic sclerosis (SSc) experienced improvement in gastrointestinal (GI) symptoms when given a gut microbiota transplant, compared with control subjects in a 16-week randomized, double-blind, placebo-controlled pilot study presented at the European Congress of Rheumatology.
We have actually got in increasing evidence that our patients with systemic sclerosis have dysbiosis and in a study together with the ucla we also showed that distinct bacteria were associated with distinct symptoms so we were thinking that if we manipulate and manipulate as i see patients with fecal microbiota transplantation that we can decrease gi symptoms
And change the microbiota composition and thereby again manipulating the symptoms this is actually a very huge burden up to a hundred percent of all patients do have gi disease and when you ask the patient this is one of the two organ manifestation born during the month the most so it is really associated with a high morbidity and we also know that it’s the size
Associated with mortality it’s actually the third most common cause of death in these patients i think it sounds scarier than it is and when you look at the literature there are different methods you can do some actually use faeces and that they install in the patients we wanted to use a standardized cultivated mixture that does not contain any virus where we
Knew which bacteria was containing in the mixture to also be able to track these bacteria afterwards so we used a commercially available anaerobic culture called hakeem in the patients to reduce well to increase the safety possibly yes at this time point it’s only possible to give by upper gastro do not copy or colonoscopy and the problem is that a lot of these
Bacteria are anaerobic so as soon as they come in contact with air and they would not be alive so this is why to date it’s only possible this culture we used to apply by gastro a little mystery but i know the company is working on producing capsules containing the same bacteria that makes them the administration much easier so we conducted a pilot a randomized
Double-blind pilot including 10 ssc patients with apparent gi disease and five of these patients were treated with hakeem the standardized cultivated anaerobic mixture of bacteria and the other half of the patient received only the media so not containing in the bacteria unfortunately we had to include one patient at the first castor de los pepes so the placebo
Group only contained four patients and when we talk about the main results we saw a clinic beneficial clinical effect especially on lower gi symptoms so the patients that had a lot of bloating and diarrhea or fecal incontinence at baseline showed the best effect of fot we did in this little pilot would not see any treatment effect on reflux disease we had the
Study content of 16 weeks so we followed the patients with six visits during the 16 weeks and we do have later follow-up in an open extension and in most of the patients the effect was actually longer than the 16 weeks one patient showed returning the symptoms after 12 weeks the patients were actually very satisfied and happy the side-effects we saw a transient
And mild however we did have a severe adverse event by the gastro dylan was copy by taking a biopsy of the patient we saw a perforation of the intestines this patient luckily was treated hospitalized and is fine we are very interested one part is that we know the patients have a dysbiosis and we think by fm t we can restore the microbiota composition on the
Other side system sources is an autoimmune disease and we know that the microbiota has an effect on immunity so we are also very interested in looking at how fm t fecal microbiota transplantation effects immunity this is much more difficult to look at as only the composition of gut microbiota and we have done it by looking also at the composition of iga igm
Coated bacteria that we think may be a sign of mucosal immunity and we also saw that the composition of bacteria that were coated with idea igm changed after after fm t but this is only a pilot so it’s only hypothesis generating and we were now very lucky and have received funding national norwegian funding for a large trial including 70 patients that we will
Start later this year so in the following next years we will know much more the effect both clinical affect microbiota composition and on the immunity you
Transcribed from video
Systemic sclerosis gastrointestinal symptoms helped by gut microbiota transplant By MDedge news and insights for busy physicians