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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 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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
430 Previous Clinical Trials
64,646 Total Patients Enrolled
~5 spots leftby May 2025
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