Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome (NCT05541003) | Clinical Trial Compass
CompletedPhase 2
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
United States12 participantsStarted 2023-01-06
Plain-language summary
This study aims to use a high-fiber supplementation, an intervention known to create shifts in the gut microbiota towards a healthier structure, to explore the relationship between gut microbiota, appetite control and feeding behavior in PWS patients.
Who can participate
Age range18 Years – 35 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Aged between 18-35 (inclusive)
* Confirmed PWS with genetic testing
* No growth hormone treatment in the previous 6 months
* Body weight \< 300 lbs.
Exclusion Criteria:
* History of other gastrointestinal disorders such as small intestinal bacterial overgrowth, celiac disease, inflammatory bowel disease, or irritable bowel syndrome.
* Pregnancy or breastfeeding
* Prior gastrointestinal or bariatric surgery
* Immunocompromised e.g., cancer treatment, bone marrow/organ transplant, immune deficiency, poorly controlled HIV/AIDS, prolonged use of steroids or other immunosuppressant medications
* Antibiotic administration in the previous 30 days
* Participation in other weight-loss programs in the previous 3 months.
* Administration of pre/probiotic supplements or antibiotics.
* Growth hormone administration in the previous 6 months
* Must have access to a smartphone, tablet, computer, or other qualifying internet-enabled device and be able to follow instructions.
* Individuals who are not proficient in English
* Contraindications for MRI scanning, including Ferrous material implanted in or on the body, including flakes or filings, surgical clips, bullets, or electrical devices such as a pacemaker, or nonremovable ferrous jewelry (fillings in teeth and permanent retainers are permitted). Individuals with surgical pins or plates above the neck are excluded. Surgical pins or plates below the neck are exclusions, except when the material is fixed to bone, and …
What they're measuring
1
Microbiome Analysis: Alpha Diversity
Timeframe: Weeks 0
2
Microbiome Analysis: Alpha Diversity
Timeframe: Week 4
3
Microbiome Analysis: Beta Diversity
Timeframe: Week 0
4
Microbiome Analysis: Beta Diversity
Timeframe: Week 4
Trial details
NCT IDNCT05541003
SponsorRutgers, The State University of New Jersey