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A Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability of (Thetanix) Bacteroides thetaiotaomicron in Adolescent Crohn's Disease
- Source :
- Clinical and Translational Gastroenterology, Hansen, R, Sanderson, I R, Muhammed, R, Allen, S J, Tzivinikos, C, Henderson, P, Gervais, L, Jeffery, I B, Mullins, D, O'Herlihy, E A, Weinberg, J D, Kitson, G, Russell, R & Wilson, D C 2020, ' A double-blind, placebo-controlled trial to assess safety and tolerability of (Thetanix®) Bacteroides thetaiotaomicron in adolescent Crohn’s disease ', Clinical and translational gastroenterology, vol. 12, no. 1, e00287 . https://doi.org/10.14309/ctg.0000000000000287
- Publication Year :
- 2020
- Publisher :
- Ovid Technologies (Wolters Kluwer Health), 2020.
-
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.
- 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
Subjects
Details
- ISSN :
- 2155384X
- Volume :
- 12
- Database :
- OpenAIRE
- Journal :
- Clinical and Translational Gastroenterology
- Accession number :
- edsair.doi.dedup.....be0b66c149273247dbbbae9c878959b6