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.


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

Read Similar Articles

🤞 Don’t miss these high yield posts and exam guidance!

Subscribe to get the Study Material and Exam Guidance posts delivered right into your mailbox.

Leave a Reply

Your email address will not be published.

Explore More Surgery Topics You Like

Best Surgery Books

MRCS Part A: Essential Revision Notes: Book 1
MRCS Part A: Essential Revision Notes: Book 2

MRCS Practice Papers Part A: Paper 1 SBAs

MRCS Practice Papers Part A: Paper 2 EMQs

Rush University Medical Center Review of Surgery

Bailey & Love Companion Guide Mcqs & Emqs In Surgery

SBA MCQs and EMQs for the MRCS Part A Pack: 2

Basic Science for the MRCS: A revision guide for surgical trainees

Oxford Handbook of Clinical Surgery

Get Through MRCS Part A: SBAs

Mrcs Module 2016 Question With Explanations For Mrcs The Best Question Series

EMQs and Data Interpretation Questions in Surgery


DrExam Part B MRCS OSCE Revision Guide: Book 1

DrExam Part B MRCS OSCE Revision Guide: Book 2

OSCEs for the MRCS Part B: A Bailey & Love Revision Guide

Succeeding in the MRCS Part B Exam: Essential revision notes for the OSCE format

Get Through MRCS: Anatomy 2E

Clinical Anatomy: Applied Anatomy for Students and Junior Doctors by Harold Ellis

Essential Radiological Anatomy for the MRCS

Surgical Critical Care: For the MRCS OSCE by Mazyar Kanani and Simon Lammy

Surgical Critical Care Vivas by Mazyar Kanani

Mcminn’s Color Atlas of Human Anatomy

Netter’s Atlas of Human Anatomy



Surgery Essence By Pritesh Singh

Surgery Sixer for NBE by Rajamahendran 4th ed (2019)

Bailey & Love Companion Guide Mcqs & Emqs In Surgery

Schwartz’s Principles of Surgery ABSITE and Board Review

Surgery PreTest Self-Assessment and Review, 13th ed


Surgery For PGMEE 13th Edition – 2019 by Amit Ashish


Bailey & Love’s Short Practice of Surgery, 27th Edition

Sabiston’s Textbook of Surgery

Schwartz’s Principles Of Surgery

SRB’S Manual Of Surgery


Operative Techniques in Surgery by Michael W. Mulholland et al

Chassin’s Operative Strategy in General Surgery

Farquharson’s Textbook of Operative General Surgery, 10th Edition


World Surgery Forum – Disclaimer
The information given on this page is for educational purposes only and should not be a substitute for professional medical advice. Do not use this information to diagnose or treat your problem without consulting your doctor. This site respects copyright and does not offer any free ebook downloads. The site and posts may contain amazon links of surgery books and products we love.

WorldSurgeryForum.net has been created by a group of Surgeons and Students, just like you. To create the best possible surgery reference and a teaching site, you can help by sharing some of your expertise, experiences, case reports, surgical images and Surgery Youtube videos. By pooling our collective knowledge and experience, we can make a real difference in how people all over the world are managed for various surgical ailments . Every new article, every case, and every image or video counts.

Check out our Social links for regular updates