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Original research
Faecal microbiota transplantation with anti-inflammatory diet (FMT-AID) followed by anti-inflammatory diet alone is effective in inducing and maintaining remission over 1 year in mild to moderate ulcerative colitis: a randomised controlled trial
  1. Saurabh Kedia1,
  2. Shubi Virmani1,
  3. Sudheer K Vuyyuru1,
  4. Peeyush Kumar1,
  5. Bhaskar Kante1,
  6. Pabitra Sahu1,
  7. Kanav Kaushal1,
  8. Mariyam Farooqui1,
  9. Mukesh Singh1,
  10. Mahak Verma1,
  11. Aditya Bajaj1,
  12. Manasvini Markandey1,
  13. Karan Sachdeva1,
  14. Prasenjit Das2,
  15. Govind K Makharia1,
  16. Vineet Ahuja1
  1. 1Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences, New Delhi, Delhi, India
  2. 2Department of Pathology, All India Institute of Medical Sciences, New Delhi, Delhi, India
  1. Correspondence to Dr Vineet Ahuja, Department of Gastroenterology, All India Institute of Medical Sciences, New Delhi, India; vineet.aiims{at}gmail.com

Abstract

Objective Microbiome and dietary manipulation therapies are being explored for treating ulcerative colitis (UC). We aimed to examine the efficacy of multidonor faecal microbiota transplantation (FMT) and anti-inflammatory diet in inducing remission followed by long-term maintenance with anti-inflammatory diet in patients with mild-moderate UC.

Design This open-labelled randomised controlled trial (RCT) randomised patients with mild-moderate (Simple Clinical Colitis Activity Index (SCCAI) 3–9) endoscopically active UC (Ulcerative Colitis Endoscopic Index of Severity (UCEIS)>1) on stable baseline medications in 1:1 ratio to FMT and anti-inflammatory diet (FMT-AID) versus optimised standard medical therapy (SMT). The FMT-AID arm received seven weekly colonoscopic infusions of freshly prepared FMT from multiple rural donors(weeks 0–6) with anti-inflammatory diet. Baseline medications were optimised in the SMT arm. Clinical responders (decline in SCCAI>3) at 8 weeks in both arms were followed until 48 weeks on baseline medications (with anti-inflammatory diet in the FMT-AID arm). Primary outcome measures were clinical response and deep remission (clinical—SCCAI <2; and endoscopic—UCEIS <1) at 8 weeks, and deep remission and steroid-free clinical remission at 48 weeks.

Results Of the 113 patients screened, 73 were randomised, and 66 were included in (35—FMT-AID; 31—SMT) modified intention-to-treat analysis (age—35.7±11.1 years; male—60.1%; disease duration—48 (IQR 24–84) months; pancolitis—34.8%; SCCAI—6 (IQR 5–7); UCEIS—4 (IQR 3–5)). Baseline characteristics were comparable. FMT-AID was superior to SMT in inducing clinical response (23/35 (65.7%) vs 11/31 (35.5%), p=0.01, OR 3.5 (95% CI 1.3 to 9.6)), remission (21/35 (60%) vs 10/31 (32.3%), p=0.02, OR 3.2 (95% CI 1.1 to 8.7)) and deep remission (12/33 (36.4%) vs 2/23 (8.7%), p=0.03, OR 6.0 (95% CI 1.2 to 30.2)) at 8 weeks. Anti-inflammatory diet was superior to SMT in maintaining deep remission until 48 weeks (6/24 (25%) vs 0/27, p=0.007).

Conclusion Multidonor FMT with anti-inflammatory diet effectively induced deep remission in mild-moderate UC which was sustained with anti-inflammatory diet over 1 year.

Trial registration number ISRCTN15475780.

  • ulcerative colitis
  • diet

Data availability statement

Data are available upon reasonable request.

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Data availability statement

Data are available upon reasonable request.

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Footnotes

  • Contributors SK: Data curation, data analysis and manuscript writing and editing. SV: Data collection, data analysis and manuscript editing. SK, PK, BK, PS, KK, KS, PD, GKM: Manuscript review and editing. MF: Diet data collection, curation and analysis. MKS, MV: Sample collection, storage, and manuscript review and editing. AB, MM: Microbiome analysis. VA: Study concept and design, funding acquisition, study supervision, data analysis,manuscript writing, editing and guarantor of the article.

  • Funding Indian Council of Medical Research: Center for Advanced Research and Excellence in Intestinal Diseases awarded to Professor Vineet Ahuja (grant number: 55/4/11/CARE-ID/2018-NCD-II).

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.