Clinical Trials Office Newsletter

April 2026 Edition

Study Spotlight

This month, we are highlighting “Autologous Fecal Microbiota Transplantation (aFMT) to Restore the Infant Gut Microbiome After Antibiotics (FMT-REPAIR)” NCT06609980, led by Dr. Maria Gloria Dominguez-Bello, Distinguished Professor in the Department of Biochemistry and Microbiology at Rutgers-SEBS.

It is known that early-life antibiotic exposure disrupts microbiome development and is associated with increased risks of asthma, allergies and metabolic disorders as well as antibiotic resistance. This study evaluates a novel strategy to restore an infant’s gut microbiome following antibiotic exposure by treating the child with their own pre-antibiotic stool. The hope is that accelerating microbiome recovery during this critical developmental window may reduce the risks of antibiotic exposure.

Consenting parents of infants and children aged 1 month to 4 years are provided with stool collection kits and are asked to collect and freeze monthly samples while their child is healthy. If the child is prescribed antibiotics, the last sample collected will be screened for intestinal pathogens, and, if negative, aFMT (whereby a small amount of the stool sample will be suspended in milk for the child to take orally) will be offered. Following aFMT, the parent is then asked to collect stool samples weekly for one month, and then monthly for 6 months, in order to determine the success of aFMT.

The study is actively recruiting participants.

Congratulations, Dr. Dominguez-Bello on this innovative study!

Investigators

Maria Gloria Dominguez-Bello, PhD, Daniel Horton, MD, MSCE, Martin J. Blaser, MD, Emily Barrett, PhD

Study Coordinators

Ekta Patel

Joseph Manzano

Please shoot us an e-mail to clinicaltrials@rbhs.rutgers.edu if you have a new study, grant award or publication from your area that you’d like to share with your fellow Rutgers Health study teams!

TOMORROW

Friday 4/17

Click to Add to Calendar

2026 CTSC Skills Acquisition Workshop Series:

Professional Development for Clinical Research Managers and Coordinators

https://www.eventbrite.com/cc/2026-ctsc-skills-acquisition-workshop-series-4821837

Introducing REDCap+: Transformative Technical Innovations Available Through Subscription

Monday, May 4th, 2026

1:00 pm

Paul Harris, PhD, Professor,

Director Biomedical Informatics

REDCap+ is an ever-growing suite of powerful features extending the capabilities of the trusted REDCap platform. Our new REDCap+ will include major technical innovations and cutting-edge features driven by Consortium needs. Advanced features will be offered to subscribers for an annual fee based on needs, at a price tailored to size. Vanderbilt will continue to support cost-free access to REDCap Core for institutions worldwide as we have done for over 20 years.

Background materials for this presentation can be found here: https://redcap.vumc.org/plus/redcap_plus_info.pdf

CDAs and NDAs submitted to RAPSS

The CTO is responsible for reviewing Confidential Disclosure Agreements (CDAs) and Non-Disclosure Agreements (NDAs) that could lead to a clinical trial. It may not always be clear to the team at Rutgers Research Contracting Services (RCS) when this is the case. To help assure that the RAPSS Document Review form is routed appropriately, you can add “Please Assign to CTO/Matt Wexler” in the comment section right before the form is submitted for review.

Regulatory Tip of the Month:

Rutgers HRPP Guidance on AI in Human Subjects Research

The Rutgers HRPP Office recently released new content on their website on Artificial Intelligence in clinical research. This comprehensive guidance provides best practices, suggested consent form language and links to additional resources.

NEW! Clinical Research Resource Guide

https://njacts.rbhs.rutgers.edu/clinical-research-resource-guide/

In an effort to provide a “one-stop shop” to view available resources for clinical researchers at Rutgers, the NJ ACTS Regulatory Core recently created a webpage to provide the necessary links at a glance. The goal is to bring awareness of the valuable services and resources available to Rutgers researchers, and to make it easier to access them. Please send any suggestions on how to improve this site and make it as useful as possible to us at clinicaltrials@rbhs.rutgers.edu.

NJMS Corner

A message from the UH-Newark Clinical Research Services team:

The UH-Newark Clinical Research Services team would like to remind study teams to please review research charges in Epic minimally within one week after a study visit, but, preferable sooner, and to prioritize any outstanding research billing review tasks by 4/30. Note that insurance companies have filing deadlines; if the research billing review isn’t completed in a timely manner, the hospital may not be able to bill for the outstanding charges.

To view incomplete Research Billing Review tasks across studies, please access the Research Coordinator – My Studies dashboard and run the Study Team Review report. If you have questions about this process or need assistance navigating the workflow, please don't hesitate to reach out to Tarek Sobhy directly (sobhyta@uhnj.org) to schedule a meeting to review. UH-CRS thanks you for your attention to this matter!

RWJMS Corner

Best Practices for the NEW RWJBH 2-Tier Charge Review

As previously announced, the RWJBH Research Billing Review team has initiated a second review of Epic charges to verify billing designations and apply the applicable codes and modifiers required by Medicare. To facilitate this process and prevent needless double work and extra emails, we recommend documenting as much billing-related information about how the study visit and procedures occurred and, if applicable, why something did not occur as expected. Here are a few examples of the kind of documentation the RBR team will look in both Epic and OnCore. Please note the screenshots were taken in the demo environment with dummy data.

For questions regarding this process change, please contact:

OnCore Support: clinicaltrials@rbhs.rutgers.edu

Research Billing Support: Epic Help Desk

Clinical Research Pets of the Month

April's clinical research pets of the month are Miss Marple and Nimbus. Their mom is Elizabeth George, Clinical Research Pharmacist at the Clinical Research Center in New Brunswick.

Both are rescues and both are around 8 years old. Nimbus is a male and was rescued from a home in Philadelphia that had 20 cats. Miss Marple is a female and was rescued from Vineland, NJ after having a litter of 6 kittens. Both had to make adjustments living with humans but have learned to trust and love each other and their owners.

Congratulations to Miss Marple, Nimbus, and Liz!

If you want your favorite pet featured in the next newsletter, reach out to us via clinicaltrials@rbhs.rutgers.edu

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We very much welcome your comments and suggestions – please drop us a line with your thoughts at clinicaltrials@rbhs.rutgers.edu.