Trial reportClinical and translational gastroenterology2020
A Double-Blind, Placebo-Controlled Trial to Assess Safety and Tolerability of (Thetanix) Bacteroides thetaiotaomicron in Adolescent Crohn's Disease.
Trial report in Clinical and translational gastroenterology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 23 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
23 citing papers in PubMed, 33 citations in OpenAlex.
- Effects of Prebiotic Yeast Mannan on Gut Health and Sleep Quality in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled Study.Nutrients · 2023Trial
- High-throughput analyses ofGut microbes · 2026Article
- Preventive and therapeutic effects of co-administration of Bacteroides thetaiotaomicron and infliximab on dextran sodium sulfate-induced colitis in mice.Intestinal research · 2026Article
- Correspondence to editorial on "Bacteroides eggerthii ameliorates metabolic dysfunction-associated steatotic liver disease through host-microbe signaling and highlights 2-hydroxyisocaproate as a potential effector".Clinical and molecular hepatology · 2026Article
- Membrane vesicles produced by next-generation probiotics from the gut as innovative tools for human health.Gut microbes · 2025Review
- Human colitis-associated colorectal carcinoma progression is accompanied by dysbiosis with enriched pathobionts.Gut microbes · 2025Article
- Bacteroides uniformis ameliorates pro-inflammatory diet-exacerbated colitis by targeting endoplasmic reticulum stress-mediated ferroptosis.Journal of advanced research · 2025Article
- StrainFacts accurately quantifies both endogenous and live biotherapeutic product strain abundances in simulated and clinical vaginal microbiota samples.bioRxiv : the preprint server for biology · 2025Article
- An engineered gut bacterium protects against dietary methylmercury exposure in pregnant mice.Cell host & microbe · 2025Article
- The Role of Beneficial Microbiota in COVID-19: Insights from Key Bacterial Genera.Microorganisms · 2025Review
- Effect ofFrontiers in nutrition · 2025Article
- Advancing the fitness of gut commensal bacteria.Science (New York, N.Y.) · 2023Article
- Bacteria require phase separation for fitness in the mammalian gut.Science (New York, N.Y.) · 2023Article
- Systems and synthetic biology-driven engineering of live bacterial therapeutics.Frontiers in bioengineering and biotechnology · 2023Review
- Review
- E. coli Nissle 1917 modulates host glucose metabolism without directly acting on glucose.Scientific reports · 2021Article
- Designing bugs as drugs: exploiting the gut microbiome.American journal of physiology. Gastrointestinal and liver physiology · 2021Review
- Identification of Novel Modalities Through Bibliometric Analysis for Timely Development of Regulatory Guidance: A Case Study of T Cell Immunity.Frontiers in medicine · 2021Article
- Prebiotic effects of yeast mannan, which selectively promotes Bacteroides thetaiotaomicron and Bacteroides ovatus in a human colonic microbiota model.Scientific reports · 2020Article
- Inflammatory Bowel Diseases: Host-Microbial-Environmental Interactions in Dysbiosis.Diseases (Basel, Switzerland) · 2020Review
Corrections and comments
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Authors and funding
14 authors at 9 institutions in 2 countries.
Funding
Abstract
introductionThetanix (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.
methodsSubjects who were 16-18 years with Crohn's in remission (weighted pediatric Crohn's disease activity index <12.5) were recruited. Each active dose comprised ∼108.2±1.4 colony forming units of B. thetaiotaomicron (randomized 4:1 active:placebo). Part A was single dose. Part B involved 7.5 days twice daily dosing. Serial stools were analyzed for calprotectin, 16S rRNA sequencing, and B. thetaiotaomicron real-time polymerase chain reaction. Bloods were taken serially. Subjects reported adverse events and recorded temperature twice daily.
resultsFifteen subjects were treated-8 in part A (75% men, median 17.1 years) and 10 in part B, including 3 from part A (80% men, median 17.1 years); all 18 completed. Seventy percent took concurrent immunosuppression. Reported compliance was >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. DISCUSSION: 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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.