1. A Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability of (Thetanix) Bacteroides thetaiotaomicron in Adolescent Crohn's Disease
- Author
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Richard K Russell, E. O'Herlihy, David C. Wilson, Paul Henderson, Rafeeq Muhammed, Lisa Gervais, Richard Hansen, Stephen Allen, Christos Tzivinikos, David Mullins, Geoff Kitson, Ian B. Jeffery, Ian R. Sanderson, and John D. Weinberg
- Subjects
DNA, Bacterial ,Male ,medicine.medical_specialty ,Abdominal pain ,Adolescent ,Placebo-controlled study ,Gastroenterology ,Article ,Placebos ,03 medical and health sciences ,symbols.namesake ,wi_140 ,0302 clinical medicine ,Crohn Disease ,Double-Blind Method ,RNA, Ribosomal, 16S ,Internal medicine ,wi_100 ,medicine ,Humans ,Adverse effect ,Fisher's exact test ,Crohn's disease ,business.industry ,Remission Induction ,Inflammatory Bowel Disease ,medicine.disease ,Gastrointestinal Microbiome ,Biological Therapy ,Bacteroides thetaiotaomicron ,Freeze Drying ,Treatment Outcome ,Tolerability ,qw_50 ,030220 oncology & carcinogenesis ,symbols ,Female ,030211 gastroenterology & hepatology ,Calprotectin ,medicine.symptom ,business ,Follow-Up Studies - Abstract
INTRODUCTION: \ud Thetanix (gastroresistant capsules containing lyophilized Bacteroides thetaiotaomicron) is a live biotherapeutic, under development for Crohn's disease, that antagonizes transcription factor nuclear factor kappa B, reducing proinflammatory cytokines, particularly tumor necrosis factor alpha. We aimed to assess safety and tolerability in adolescents with Crohn's disease in remission.\ud \ud METHODS: \ud Subjects who were 16–18 years with Crohn's in remission (weighted pediatric Crohn's disease activity index 99% in part B. Two subjects reported adverse events deemed related—one in part A with eructation, flatulence, and reflux; one in part B with dizziness, abdominal pain, and headache. No serious adverse events were reported. There was no significant change in median calprotectin across part B (87.8 [4.4–447] to 50.5 [5.3–572], P = 0.44 by the Fisher exact test in the active group). No significant differences were found in microbiota profiles, but diversity seemed to increase in treated subjects.\ud \ud DISCUSSION: \ud Thetanix, after single and multiple doses, was well tolerated. Although the numbers in this study were small, the safety profile seems good. Future studies should explore efficacy.
- Published
- 2020