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Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation (clinicaltrials.gov) - Jun 22, 2023
P2, N=18, Recruiting,
N=18 --> 7 | Recruiting --> Terminated; Slow patient recruitment Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Mar 2024
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Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation (clinicaltrials.gov) - Apr 21, 2023
P2, N=18, Recruiting,
Trial completion date: Feb 2024 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Mar 2024 Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Dec 2023
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Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation (clinicaltrials.gov) - Oct 20, 2022
P2, N=18, Recruiting,
Trial completion date: Jun 2023 --> Feb 2024 | Trial primary completion date: Mar 2023 --> Dec 2023 Trial completion date: Feb 2022 --> Jun 2023 | Trial primary completion date: Feb 2022 --> Mar 2023
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Biomarker, Clinical, Journal: ILB Attenuates Clinical Symptoms and Serum Biomarkers of Oxidative/Nitrosative Stress and Mitochondrial Dysfunction in Patients with Amyotrophic Lateral Sclerosis. (Pubmed Central) - Aug 28, 2021
P=N/A
A significant normalization of the serum levels of several key metabolites was observed over the treatment period, including N-acetylaspartate (NAA), oxypurines, biomarkers of oxidative/nitrosative stress and antioxidants. An improved serum metabolic profile was accompanied by significant amelioration of the patients' clinical conditions, indicating a response to ILB treatment that appears to be mediated by improvement of tissue bioenergetics, decrease of oxidative/nitrosative stress and attenuation of (neuro)inflammatory processes.
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Trial completion date, Trial primary completion date: A Safety and Tolerability Study of ILB in Patients With Amyothrophic Lateral Sclerosis (ALS) (clinicaltrials.gov) - May 5, 2021
P2, N=11, Active, not recruiting,
The results of this study reveal the anti-inflammatory effect and mechanism of AG and provide an important reference for studying the mechanisms of natural flavonoids involved in preventing inflammation-driven diseases. Trial completion date: May 2021 --> Aug 2021 | Trial primary completion date: Apr 2021 --> Aug 2021
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Enrollment open, Trial completion date, Trial primary completion date: Study to Evaluate Safety and Efficacy of IBsolvMIR in Islet Transplantation (clinicaltrials.gov) - Feb 16, 2021
P2, N=18, Recruiting,
Therefore, GM is a promising candidate for development into a novel therapeutic agent for UC. Trial completion date: Oct 2021 --> Feb 2022 | Trial primary completion date: Oct 2021 --> Feb 2022 | Not yet recruiting --> Recruiting
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Journal: Desmocollin-2 promotes intestinal mucosal repair by controlling integrin-dependent cell adhesion and migration. (Pubmed Central) - Jan 23, 2021
In-vitro analyses using human intestinal cell lines after knockdown of Dsc2 revealed delayed epithelial cell migration and repair after scratch wound healing assay that was associated with reduced cell-matrix traction forces, decreased levels of integrin β1 and β4, and altered activity of the small GTPase Rap1. Taken together these results demonstrate that epithelial Dsc2 is a key contributor to intestinal mucosal wound healing in-vivo.
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Journal: Effect of N-palmitoylethanolamine-oxazoline on comorbid neuropsychiatric disturbance associated with inflammatory bowel disease. (Pubmed Central) - Jan 23, 2021
The aim of this study is to explore the mechanism and the effect of PEA-OXA on the gut-brain axis in rats subjected to experimental colitis induced by oral administration of dextran sulfate sodium (DSS)...Moreover, PEA-OXA restored intestinal permeability and tight junctions (TJs) as well as reduced apoptosis in the colon and brain. In our work, we demonstrated, for the first time, the action of PEA-OXA on the gut-brain axis in a model of DSS-induced colitis and its implication on the "secondary" effects associated with colonic disturbance.
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Journal: Panax notoginseng saponins prevent colitis-associated colorectal cancer development: the role of gut microbiota. (Pubmed Central) - Jan 23, 2021
In this study, the effects of Panax notoginseng saponins (PNS) on colitis-associated CRC progression were evaluated on an azoxymethane (AOM)/dextran sulfate sodium (DSS) mouse model...Moreover, ginsenoside compound K (GC-K) was evaluated on the effects of human CRC cells, which was the main bio-transformed metabolite of PNS by gut microbiota. Our data showed that PNS played important role in the prevention of the progression of CRC, due to their regulation on the microbiome balance and microbial bio-converted product with anti-CRC activity.
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Journal: CREPT is required for murine stem cell maintenance during intestinal regeneration. (Pubmed Central) - Jan 23, 2021
Vil-CREPT intestine fails to regenerate after X-ray irradiation and dextran sulfate sodium (DSS) treatment...We identify that CREPT deficiency downregulates Wnt signaling by impairing β-catenin accumulation in the nucleus of the crypt cells during regeneration. Our study provides a previously undefined regulator of ISCs.
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Journal: Aberrant SLC6A14 Expression Promotes Proliferation and Metastasis of Colorectal Cancer via Enhancing the JAK2/STAT3 Pathway. (Pubmed Central) - Jan 22, 2021
Besides, azoxymethane/dextran sulfate sodium salt (AOM/DSS)-induced CRC and tumor xenograft models were constructed to explore the effects of SLC6A14 blockade or overexpression during tumor progression in vivo...Besides, two different animal studies verified the tumor-promoting effect of SLC6A14 in CRC. Our data illustrated the crucial function of SLC6A14 during CRC progression, suggesting SLC6A14/JAK2/STAT3 axis may serve as novel therapeutic targets for patients with CRC.
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Journal, IO biomarker: Platelet activating factor receptor acts to limit colitis-induced liver inflammation. (Pubmed Central) - Jan 21, 2021
Here, we examined the role of platelet activating factor receptor (PAFR) in colitis-associated liver damage using dextran sulfate sodium (DSS) and anti-CD40-induced colitis models...Interestingly, KCs depletion also increased IL-1β protein in mouse liver after DSS challenge. These data suggest a protective role for PAFR-expressing KCs during colitis and that regulation of PAFR is important for gut-liver axis homeostasis.
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Preclinical, Journal: Ping weisan alleviates chronic colitis in mice by regulating intestinal microbiota composition. (Pubmed Central) - Jan 14, 2021
The above results demonstrate that IG exerts its inhibitory effect on cell apoptosis, oxidative stress, and proinflammatory cytokines in DSS-induced colitis through modulation of the TLR2/4/MyD88/NF-κB signaling pathway. Combining with our previous results, we found that PWS could exert anti-UC role by rebalancing intestinal bacteria.
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Preclinical, Journal: Cholesterol 25-hydroxylase protects against experimental colitis in mice by modulating epithelial gut barrier function. (Pubmed Central) - Jan 13, 2021
Dextran sulfate sodium (DSS)-induced colitis was monitored in wild type and Ch25h mice in 8-week-old male for 7 days by assessment of body weight, histology, inflammatory cellular infiltration, and colon length...Taken together, our findings reveal a protective role for 25-HC in DSS-induced colitis and the ability of CH25H to maintain epithelial gut barrier function through ATF3 expression. Supplementation with exogenous 25-HC ameliorates disease symptoms, which provides a new therapeutic strategy for ulcerative colitis.
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Preclinical, Journal: Efficient treatment of a preclinical inflammatory bowel disease model with engineered bacteria. (Pubmed Central) - Jan 12, 2021
The expression levels of TNF and other cytokines significantly decreased upon this treatment in dextran sulfate sodium (DSS)-induced colitis, and the degree of inflammation was significantly reduced. With further safety modifications this method could serve as a safe and side effect-free alternative to biologicals targeting TNF or other inflammatory mediators.
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Journal: ILB resolves inflammatory scarring and promotes functional tissue repair. (Pubmed Central) - Jan 9, 2021
We investigated the effects of a newly formulated low molecular weight dextran sulfate (LMW-DS), termed ILB, to resolve inflammation and activate matrix remodelling in rodent and human disease models...Of particular relevance, we demonstrated that ILB acts, in part, by downregulating transforming growth factor (TGF)β signalling genes and by altering gene expression relating to extracellular matrix dynamics, leading to tissue remodelling, reduced fibrosis and functional tissue regeneration. These observations indicate the potential of ILB to alleviate fibrotic diseases.
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Journal: Enhanced Transport of Shape and Rigidity-tuned α-lactalbumin Nanotubes across Intestinal Mucus and Cellular Barriers. (Pubmed Central) - Jan 6, 2021
In the end, the mechanism of the high permeability of SNT through mucus was explained by coarse-grained molecular dynamics simulations, which indicated that short timescale jiggling and flying across pores of mucus network played key roles. These findings revealed the tubular α-lac PSs could be a promising oral drug delivery system targeted to mucosal for improving absorption and bioavailability of hydrophobic bioactive ingredients.
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Journal: Human umbilical cord mesenchymal stem cells alleviate inflammatory bowel disease by inhibiting ERK phosphorylation in neutrophils. (Pubmed Central) - Jan 6, 2021
Here, we constructed a dextran sulfate sodium (DSS)-induced mouse IBD model and evaluated the effects of treatment with human umbilical cord MSCs...In vitro experiments showed that addition of the ERK phosphorylation inhibitor, PD98059, down-regulated the expression of N1 neutrophils, while up-regulating that of N2 neutrophils...Further, relative to healthy controls, the markers of N1 neutrophils (ICAM-1, FAS, and CCL3) were highly expressed in colon tissues from patients with IBD, whereas the markers of N2 neutrophils (VEGF, CCL2, and CXCR4) were almost undetectable. In conclusion, during alleviation of IBD, human umbilical cord MSCs polarise neutrophils toward the "N2" phenotype by inhibiting activation of ERK signalling.
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Journal: Lycopene alleviates DSS-induced colitis and behavioral disorders via mediating microbes-gut-brain axis balance. (Pubmed Central) - Jan 6, 2021
The current study demonstrated that LYC treatment (50 mg/kg body weight/day) for 40 days prevented the dextran sulfate sodium (DSS)-induced gut barrier damages and inflammatory responses in male mice...LYC also elevated the generation of short-chain fatty acids and inhibited the permeability of lipopolysaccharide in colitis mice. In conclusion, LYC ameliorate DSS-induced colitis and behavioral disorders via mediating microbes-gut-brain axis balance.
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Preclinical, Journal: Dietary Mixed Cereal Grains Ameliorate the Azoxymethane and Dextran Sodium Sulfate-Induced Colonic Carcinogenesis in C57BL/6J Mice. (Pubmed Central) - Jan 6, 2021
The chemopreventive effects of various mixed cereal grain (MCG) samples on azoxymethane (AOM, 10 mg/kg) and dextran sulfate sodium (DSS, 0.02 g/mL)-induced colorectal cancer (CRC) in C57BL/6J mice were studied...In addition, MCG-PC increased the mRNA expressions of tumor suppressor protein p53 (Tp53) and cyclin-dependent kinase inhibitor 1A (Cdkn1a), activated pro-apoptotic caspase 3 (Casp3), and reduced expressions of both mRNA and protein of inducible nitric oxide synthase 2 (Nos2), prostaglandin-endoperoxide synthase 2 (Ptgs2), and cyclin D1 (Ccnd1) in colon tissue. These findings suggest that compared with other cereal grain preparations, MCG-PC had a greater activity against AOM/DSS-induced CRC by reducing intestinal inflammation and modulating the expression of certain carcinogenesis related factors (Nos2, Ptgs2, Tp53, Cdkn1a, Ccnd1, and Casp3) in colon tissue of CRC mice.
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Journal: Algal Oil Rich in n-3 PUFA Alleviates DSS-Induced Colitis via Regulation of Gut Microbiota and Restoration of Intestinal Barrier. (Pubmed Central) - Jan 5, 2021
This study aimed to investigate the effects of DHA algal oil on colonic inflammation and intestinal microbiota in dextran sulfate sodium (DSS)-induced colitis mice model...On the analysis of SCFAs, the caecal content of acetic acid, propionic acid, isobutyric acid, buturic, and the total SCFAs showed a significant increase in algal oil-administered mice. Together, these results suggested that algal oil rich in DHA inhibited the progress of DSS-induced colitis in mice by modulating the intestinal microbiota and metabolites and repairing the intestinal barrier, which may be applied in the development of therapeutics for intestinal inflammation.
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Journal: Gut epithelial TSC1/mTOR controls RIPK3-dependent necroptosis in intestinal inflammation and cancer. (Pubmed Central) - Jan 1, 2021
mTOR hyperactivation triggered by Western diet or Tsc1 ablation led to epithelium necroptosis, barrier disruption, and predisposition to dextran sulfate sodium-induced colitis and inflammation-associated colon cancer...mTOR primarily impinged on RIPK3 to potentiate TNF- and microbial PAMP-induced necroptosis, and hyperactive mTOR and aberrant necroptosis were intertwined in human IBDs. Together, our data reveal a previously unsuspected link between the Western-diet, microbiota and necroptosis, and identify the mTOR-RIPK3-necroptosis axis as a driving force for intestinal inflammation and cancer.
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Journal: Nobiletin Attenuates DSS-Induced Intestinal Barrier Damage through HNF4α-claudin-7 Signaling Pathway. (Pubmed Central) - Dec 31, 2020
Clinical and pathological test results suggested that administration of NOB effectively alleviates intestinal barrier injury induced by dextran sulfate sodium (DSS) as evidenced by the length of colon villi on day 7 (control, 253.7 ± 4.8 μm, DSS 131.6 ± 4.6 μm, NOB + DSS, 234.5 ± 5.1 μm...Furthermore, hepatocyte nuclear factor 4α (HNF-4α) transcriptional regulation of claudin-7 contributed to intestinal barrier homeostasis. Therefore, our study suggests potential intestinal protective strategies based on polymethoxyflavones of aged tangerine peels.
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Preclinical, Journal: Hypoxia Augments Cerebral Inflammation in a Dextran Sulfate Sodium-Induced Colitis Mouse Model. (Pubmed Central) - Dec 29, 2020
Moreover, the expression of tight junction proteins, such as zonula occludens-1 (ZO-1), occludin, and claudin-5, was markedly downregulated. The current study provides new insight into how hypoxia exposure induces excessive inflammatory responses andpathophysiological consequences in the brain in a DSS-induced colitis model.
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PK/PD data, Preclinical, Journal: Pharmacokinetics of omeprazole in rats with dextran sulfate sodium-induced ulcerative colitis. (Pubmed Central) - Dec 23, 2020
The hepatic CYP1A2 and CYP3A1 protein levels in UC rats were 42.6 and 45.2% lower than those in normal rats, respectively; however, the protein levels of CYP2D1 in the two groups were similar. The activity and expression of some hepatic CYP450 isoforms were decreased by UC, leading to changes in the pharmacokinetics of omeprazole.
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