Phase 2
Completed N=12
Understanding the Role of Gut Microbiota in Hyperphagia in Prader-Willi Syndrome
Source: ClinicalTrials.gov NCT05541003 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcomePrimary: Microbiome Analysis: Alpha Diversity — 4.89 Shannon index
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Microbiome Analysis: Alpha Diversity |
4.73 | — |
| PRIMARY Microbiome Analysis: Beta Diversity |
0.73 | — |
| SECONDARY Weight |
107 | — |
| SECONDARY Acyl-Ghrelin Level |
12.5; 278 | — |
| SECONDARY Peptide YY (PYY) |
0.614; 11.1 | — |
| SECONDARY Glucagon Like Peptide 1 (GLP1) |
4.44; 79.6 | — |
| SECONDARY Insulin Level |
1607; 7427 | — |
| SECONDARY Glucose Level |
182; 375 | — |
| SECONDARY Calorie Count |
1840 | — |
| SECONDARY Hyperphagia Questionnaire |
5.3; 5.7; 3.1 | — |
Eligibility Criteria
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 considered acceptable by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, 2020 Edition. Almost all recent orthopedic implants are made of materials that are not ferromagnetic and therefore are safe for scanning, and even though some screws are still made of ferromagnetic materials these are firmly screwed into bone. In cases where the material is unknown or deemed unsafe for scanning by the Reference Manual for Magnetic Resonance Safety. Implants and Devices, the participant will be excluded. History of eye injury involving metallic materials, shavings in eyes, or welding without a face mask. Lead/iron tattoos and tattoos performed by a nonprofessional artist if the pigment material is unknown. Claustrophobia (history of significant anxiety in closed places).
- Back problem that would prevent the subject from laying still comfortably for up to 60 minutes.
Data sourced from ClinicalTrials.gov (NCT05541003). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.