← Back to Search

Other

NBT-NM108 for Prader-Willi Syndrome (PWSGUT Trial)

Phase 2

Waitlist Available

Research Sponsored by Rutgers, The State University of New Jersey

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 4

Awards & highlights

PWSGUT Trial Summary

This trial will use a high-fiber supplement to see if it affects appetite control and feeding behavior in people with Prader-Willi Syndrome.

Eligible Conditions

Prader-Willi Syndrome
Obesity

PWSGUT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 4

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 4

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 4 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Gut microbiota composition

Secondary outcome measures

24 hour dietary recall

Magnetic Resonance Imaging

Ghrelin level

+4 more

PWSGUT Trial Design

1Treatment groups

Experimental Treatment

Group I: Experimental ArmExperimental Treatment1 Intervention

All participants will receive NBT-NM108 prepared as muffin (each contains 30 g of the product) for 4 weeks. The dosage will be 2 muffins a day. This dosage of NBT-NM108 will provide 24 g/day of dietary fibers.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

NBT-NM108

2023

Completed Phase 2

~60

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor

429 Previous Clinical Trials

64,220 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any openings for participants in this research endeavor?

"According to clinicaltrials.gov, the trial is currently recruiting patients and was first posted on November 1st 2022 with its most recent update occurring on November 11th of that same year."

Answered by AI

Am I a suitable candidate for this investigation?

"This experiment is seeking 10 participants between 18 and 35 years old with a diagnosis of obesity. Additional requirements for enrollment include confirmation of Prader-Willi Syndrome via genetic testing, no growth hormone treatment in the last half year, and body weight under 300 pounds."

Answered by AI

Could you describe the safety profile of NBT-NM108?

"Our internal assessment of NBT-NM108 assigns it a safety rating of 2, as this is still in the Phase 2 trials and there isn't yet any data to support efficacy."

Answered by AI

Is the eligibility for this clinical test limited to those under 25, or can adults participate as well?

"According to the trial's eligibility requirements, only patients between 18 and 35 years old can be enrolled."

Answered by AI

How many participants are enrolled in the study at its current capacity?

"Affirmative. According to information found on clinicaltrials.gov, this research is actively trying to enroll participants. The experiment was initially posted on the 1st of November 2022 and has been revised as recently as 11th November 2022. A total of 10 patients are sought from one single site for participation in the trial."

Answered by AI

Recent research and studies

American Journal of Medical Genetics Part AJournal

Contributing Factors of Mortality in Prader–willi Syndrome

Proffitt, Jennifer, Kathryn Osann, Barbara McManus, Virginia E. Kimonis, Janalee Heinemann, Merlin G. Butler, David A. Stevenson, and June‐Anne Gold. 2018. “Contributing Factors of Mortality in Prader–willi Syndrome”. American Journal of Medical Genetics Part A. Wiley. doi:10.1002/ajmg.a.60688.

EBioMedicineJournal

Dietary Modulation of Gut Microbiota Contributes to Alleviation of Both Genetic and Simple Obesity in Children

Zhang, Chenhong, Aihua Yin, Hongde Li, Ruirui Wang, Guojun Wu, Jian Shen, Menghui Zhang, et al.. 2015. “Dietary Modulation of Gut Microbiota Contributes to Alleviation of Both Genetic and Simple Obesity in Children”. Ebiomedicine. Elsevier BV. doi:10.1016/j.ebiom.2015.07.007.

ObesityJournal

Assessment of Hyperphagia in Prader-willi Syndrome*

Dykens, Elisabeth M., Melissa A. Maxwell, Elizabeth Pantino, Rebecca Kossler, and Elizabeth Roof. 2007. “Assessment of Hyperphagia in Prader-willi Syndrome*”. Obesity. Wiley. doi:10.1038/oby.2007.216.

AppetiteJournal