Early Assessment With Gastrointestinal Ultrasound in Patients Hospitalised for a Flare of Ulcerative Colitis and Predicting the Need for Salvage Therapy: A Pilot Study

2021 ◽  
Author(s):  
Rebecca L. Smith ◽  
Kirstin M. Taylor ◽  
Antony B. Friedman ◽  
Adrian P. Swaine ◽  
David J. Gibson ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Salvage Therapy ◽  
Early Assessment ◽  
Gastrointestinal Ultrasound

EVALUATION OF A DIET AND ANTIBIOTICS TARGETING THE MICROBIOTA FOR TREATMENT OF MILD TO MODETARE ACTIVE PEDIARTIC ULCERATIVE COLITIS: AN OPEN LABEL PILOT STUDY

2021 ◽  
Vol 27 (Supplement_1) ◽  
pp. S38-S38
Author(s):  
Chen Sarbagili-Shabat ◽  
Lindsey Albenberg ◽  
Johan Van Limbergen ◽  
Dror Weiner ◽  
Michal Yaakov ◽  
...  
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Dietary Intervention ◽  
Activity Index ◽  
Fecal Calprotectin ◽  
Dietary Therapy ◽  
The Novel ◽  
Open Label ◽  
Intention To Treat ◽  
Stable Maintenance

Abstract Background Newer strategies that target the microbiome may offer an alternative therapeutic approach for Ulcerative Colitis (UC). We developed a novel diet that targets changes in the microbiome and barrier function that have been reported in UC. The goal of the current study was to evaluate the efficacy of two sequential induction of remission strategies that target the microbiota: the novel diet termed the ulcerative colitis diet (UCD) and an antibiotics cocktail combination in dietary non responders. Methods This was a prospective, single arm, open label, pilot study in patients aged 8–19, with a pediatric UC activity index (PUCAI) scores >10 and ≤45 on stable maintenance therapy (5ASA or thiopurines). PUCAI score was assessed at week 3 and 6. Patients failing to enter remission or intolerant to dietary therapy could receive an open label 14-day course of Amoxycillin, Metronidazole and Doxycycline (AMD), and had PUCAI scored at day 21. Response was defined a decline in PUCAI ≥ 10 points, remission as PUCAI< 10. The primary endpoint was intention to treat (ITT) remission at week 6 with diet as the sole intervention. Results Twenty-three children mean age of 15.1±2.9 years were enrolled. Two patients (1 responder, 1 remission) withdrew by 3 weeks, four required additional therapy by week 3, all were considered failures by ITT. Mean PUCAI decreased at week 3 and 6 from 34.5±9.8 to 21.7±14.9 and 17.6±17.2 respectively (P=0.005, P=0.001) at ITT analysis including all patients. Sixteen out of twenty-three patients (69.6%) responded by week 6. Ten of twenty-three (43.5%) achieved remission by week 6, and nine (39.1%) had clinical remission at week 6. The median fecal calprotectin (FC) level decreased in patients (n=5) who achieved remission from 630 (IQR, 332–1586) μg/g at week 0 to 230 (75–1298) μg/g at week 6. Eight patients received treatment with antibiotics after failing diet, 4/8 (50.0%) subsequently entered remission. Conclusion A dietary intervention called the UC Diet appears to be effective for induction of remission in children with mild to moderate UC. Sequential use of diet, followed by antibiotic therapy in dietary non responders, needs further evaluation as a microbiome directed steroid sparing therapy in patient’s refractory to 5ASA and thiopurines.

scholarly journals Creatine Supplementation for Patients with Inflammatory Bowl Diseases: A Scientific Rationale for a Clinical Trial

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1429
Author(s):  
Theo Wallimann ◽  
Caroline H. T. Hall ◽  
Sean P. Colgan ◽  
Louise E. Glover
Keyword(s):  
Ulcerative Colitis ◽  
Clinical Trial ◽  
Crohn’S Disease ◽  
Pilot Study ◽  
Crohn's Disease ◽  
Single Case ◽  
Initial Period ◽  
Creatine Supplementation

Based on theoretical considerations, experimental data with cells in vitro, animal studies in vivo, as well as a single case pilot study with one colitis patient, a consolidated hypothesis can be put forward, stating that “oral supplementation with creatine monohydrate (Cr), a pleiotropic cellular energy precursor, is likely to be effective in inducing a favorable response and/or remission in patients with inflammatory bowel diseases (IBD), like ulcerative colitis and/or Crohn’s disease”. A current pilot clinical trial that incorporates the use of oral Cr at a dose of 2 × 7 g per day, over an initial period of 2 months in conjunction with ongoing therapies (NCT02463305) will be informative for the proposed larger, more long-term Cr supplementation study of 2 × 3–5 g of Cr per day for a time of 3–6 months. This strategy should be insightful to the potential for Cr in reducing or alleviating the symptoms of IBD. Supplementation with chemically pure Cr, a natural nutritional supplement, is well tolerated not only by healthy subjects, but also by patients with diverse neuromuscular diseases. If the outcome of such a clinical pilot study with Cr as monotherapy or in conjunction with metformin were positive, oral Cr supplementation could then be used in the future as potentially useful adjuvant therapeutic intervention for patients with IBD, preferably together with standard medication used for treating patients with chronic ulcerative colitis and/or Crohn’s disease.

Mo1889 CORRELATION OF EARLY INFLIXIMAB LEVELS WITH SHORT TERM OUTCOMES IN STEROID REFRACTORY ULCERATIVE COLITIS: A PILOT STUDY

2020 ◽  
Vol 158 (6) ◽  
pp. S-964-S-965
Author(s):  
Srishti Saha ◽  
Prabhjot Grace Dosanjh ◽  
Edward V. Loftus ◽  
Sahil Khanna ◽  
Darrell S. Pardi
Keyword(s):  
Ulcerative Colitis ◽  
Pilot Study ◽  
Short Term ◽  
Steroid Refractory

scholarly journals A Web-Based Communication Platform to Improve Home Care Services in Norway (DigiHelse): Pilot Study (Preprint)

2019 ◽  
Author(s):  
Linn Nathalie Støme ◽  
Tron Moger ◽  
Kristian Kidholm ◽  
Kari J Kværner
Keyword(s):  
Pilot Study ◽  
Home Care ◽  
Rate Ratio ◽  
Care Service ◽  
Behavioral Data ◽  
Home Care Service ◽  
Early Assessment ◽  
Web Based ◽  
Digital Platform ◽  
One Year

BACKGROUND Home care service in Norway is struggling to meet the increasing demand for health care under restricted budget constraints, although one-fourth of municipal budgets are dedicated to health services. The integration of Web-based technology in at-home care is expected to enhance communication and patient involvement, increase efficiency and reduce cost. DigiHelse is a Web-based platform designed to reinforce home care service in Norway and is currently undergoing a development process to meet the predefined needs of the country’s municipalities. Some of the main features of the platform are digital messages between residents and the home care service, highlighting information on planned and completed visits, the opportunity to cancel visits, and notifications for completed visits. OBJECTIVE This study aimed to test the usability and economic feasibility of adopting DigiHelse in four districts in Oslo by applying registry and behavioral data collected throughout a one-year pilot study. Early health technology assessment was used to estimate the potential future value of DigiHelse, including the predictive value of behavior data. METHODS Outcome measures identified by stakeholder insights and scenario drafting in the project’s concept phase were used to assess potential socioeconomic benefits. Aggregated data were collected to assess changes in health consumption at baseline, and then 15 and 52 weeks after DigiHelse was implemented. The present value calculation was updated with data from four intervention groups and one control group. A quasi-experimental difference-in-difference design was applied to estimate the causal effect. Descriptive behavioral data from the digital platform was applied to assess the usability of the platform. RESULTS Over the total study period (52 weeks), rates increased for all outcome estimates: the number of visits (rate ratio=1.04; <italic>P</italic>=.10), unnecessary trips (rate ratio=1.37; <italic>P</italic>=.26), and phone calls (rate ratio=1.24; <italic>P</italic>=.08). A significant gap was found between the estimated value of DigiHelse in the concept phase and after the one-year pilot. In the present pilot assessment, costs are expected to exceed potential savings by €67 million (US $75 million) over ten years, as compared to the corresponding concept estimates of a potential gain of €172.6 million (US $193.6 million). Interestingly, behavioral data from the digital platform revealed that only 3.55% (121/3405) of recipients actively used the platform after one year. CONCLUSIONS Behavioral data provides a valuable source for assessing usability. In this pilot study, the low adoption rate may, at least in part, explain the inability of DigiHelse to perform as expected. This study points to an early assessment of behavioral data as an opportunity to identify inefficiencies and direct digital development. For DigiHelse, insight into why the recipients in Oslo have not made greater use of the Web-based platform seems to be the next step in ensuring the right improvement measures for the home care service.

scholarly journals A Web-Based Communication Platform to Improve Home Care Services in Norway (DigiHelse): Pilot Study

10.2196/14780 ◽  
2020 ◽  
Vol 4 (1) ◽  
pp. e14780
Author(s):  
Linn Nathalie Støme ◽  
Tron Moger ◽  
Kristian Kidholm ◽  
Kari J Kværner
Keyword(s):  
Pilot Study ◽  
Home Care ◽  
Rate Ratio ◽  
Care Service ◽  
Behavioral Data ◽  
Home Care Service ◽  
Early Assessment ◽  
Web Based ◽  
Digital Platform ◽  
One Year

Background Home care service in Norway is struggling to meet the increasing demand for health care under restricted budget constraints, although one-fourth of municipal budgets are dedicated to health services. The integration of Web-based technology in at-home care is expected to enhance communication and patient involvement, increase efficiency and reduce cost. DigiHelse is a Web-based platform designed to reinforce home care service in Norway and is currently undergoing a development process to meet the predefined needs of the country’s municipalities. Some of the main features of the platform are digital messages between residents and the home care service, highlighting information on planned and completed visits, the opportunity to cancel visits, and notifications for completed visits. Objective This study aimed to test the usability and economic feasibility of adopting DigiHelse in four districts in Oslo by applying registry and behavioral data collected throughout a one-year pilot study. Early health technology assessment was used to estimate the potential future value of DigiHelse, including the predictive value of behavior data. Methods Outcome measures identified by stakeholder insights and scenario drafting in the project’s concept phase were used to assess potential socioeconomic benefits. Aggregated data were collected to assess changes in health consumption at baseline, and then 15 and 52 weeks after DigiHelse was implemented. The present value calculation was updated with data from four intervention groups and one control group. A quasi-experimental difference-in-difference design was applied to estimate the causal effect. Descriptive behavioral data from the digital platform was applied to assess the usability of the platform. Results Over the total study period (52 weeks), rates increased for all outcome estimates: the number of visits (rate ratio=1.04; P=.10), unnecessary trips (rate ratio=1.37; P=.26), and phone calls (rate ratio=1.24; P=.08). A significant gap was found between the estimated value of DigiHelse in the concept phase and after the one-year pilot. In the present pilot assessment, costs are expected to exceed potential savings by €67 million (US $75 million) over ten years, as compared to the corresponding concept estimates of a potential gain of €172.6 million (US $193.6 million). Interestingly, behavioral data from the digital platform revealed that only 3.55% (121/3405) of recipients actively used the platform after one year. Conclusions Behavioral data provides a valuable source for assessing usability. In this pilot study, the low adoption rate may, at least in part, explain the inability of DigiHelse to perform as expected. This study points to an early assessment of behavioral data as an opportunity to identify inefficiencies and direct digital development. For DigiHelse, insight into why the recipients in Oslo have not made greater use of the Web-based platform seems to be the next step in ensuring the right improvement measures for the home care service.

scholarly journals Use of Serum Infliximab Level Prior to Cyclosporine Salvage Therapy in Severe Ulcerative Colitis

2014 ◽  
Vol 1 (3) ◽  
pp. 148-150 ◽  
Author(s):  
Christopher G. Chapman ◽  
Ashley Bochenek ◽  
Adam C. Stein ◽  
David T. Rubin
Keyword(s):  
Ulcerative Colitis ◽  
Salvage Therapy ◽  
Severe Ulcerative Colitis
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