LOTUS Trial: Lyophilised oral faecal microbiota transplantation for Ulcerative Colitis

Surgery Clinical Trials
2 mn read

Below is the summary of the LOTUS Trial (LOTUS: Lyophilised oral faecal microbiota transplantation for ulcerative colitis):

Faecal microbiota transfer (FMT) delivered via colonoscopic infusions or enemas have been proven to cause the remission of a portion of patients suffering from chronic ulcerative colitis. Whether orally administered FMT is effective in patients with ulcerative colitis is not known.

The LOTUS Trial (LOTUS: Lyophilised oral faecal microbiota transplantation for ulcerative colitis) that is a double-blind controlled, randomised trial was carried out at two centers in Australia.

It was designed to test the effectiveness of FMT that is lyophilised and administered orally in treating the active colitis ulcerative.

Patients who were eligible ranged from 18 to 75 years, with chronic ulcerative colitis (defined by endoscopic and clinical active ulcerative colitis, having an overall Mayo score between 4 and 10 and an Mayo endoscopic subscore greater than 1).

After two weeks of metronidazole, amoxicillin and Doxycycline, the patients were randomly allocated in the ratio 1:1 of either orallyophilised FMT , or placebo capsules for eight weeks using a pre-specified computer-generated randomisation schedule with the permuted Block size of eight.

The primary outcome was corticosteroid free clinical remission, with endoscopic resolution or response (total Mayo score <=2, all subscores >;=1 and >=1 point reduction in the subscore of the endoscopic) in week 8.

In week 8 of FMT, respondents had been randomly assigned (in an 1:1 ratio with a permuted blocks of 8) to either keep or stop FMT for an additional 48 weeks.

Findings Summary

Between May 20, 2019, and March 24, 2020, 35 patients were randomly assigned: 15 to receive FMT and 20 to receive placebo.

The program was cut off early because of the COVID-19 pandemic.

By week 8, eight (53 percent) of 15 patients from the FMT group were in corticosteroid free clinical remission that included an endoscopic response or remission, like three (15 percent) from 20 participants in the control group (difference 38.3 percent, 95% confidence interval 8.6-68.0 (p=0.027; odds ratio 5.0 (95 percent 1- 8-14.1).

Acute adverse events occurred in 10 (67 percent) participants in the FMT group, and 17 (85 percent) of the placebo group throughout the eight-week period of induction and were mostly benign and self-limiting digestive complaints.

The most serious adverse events were the worsening of ulcerative colitis (two in the FMT group One for the group with a placebo) as well as Per-rectal bleeding (one in the placebo group).

Ten patients from the FMT group that had an endoscopic or clinical response were enrolled in the maintenance phase. They were placed in with open-label FMT (n=4) as well as to withdraw treatment (n=6). Four (100 percent) of the patients that continued FMT were in endoscopic, clinical, and histologic remission by week 56, in contrast to none of those who were FMT removed.

Interpretation

Antibiotics accompanied by oral administration of FMT resulted in the improvement of remission in patients suffering from active ulcerative colitis.

The FMT treatment was tolerated for a long time and showed clinical, endoscopic and histological effectiveness.

Oral FMT may be an effective and viable option for patients suffering from ulcerative colitis.

Reference: LOTUS Trial (LOTUS: Lyophilised oral faecal microbiota transplantation for ulcerative colitis) https://www.thelancet.com/journals/langas/article/PIIS2468-1253(21)00400-3/fulltext

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