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The ameliorating effect of intestinal microbiota-targeted nutritional intervention on metabolic dysfunction of Prader–Willi syndrome patients

The ameliorating effect of intestinal microbiota-targeted nutritional intervention on metabolic dysfunction of Prader–Willi syndrome patients

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-ONC-12002646
Enrollment
Unknown
Registered
2012-10-25
Start date
2012-10-11
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prader–Willi syndrome

Interventions

intervention Group:high-polysacchrides and low fat dietary intervention

Sponsors

Shanghai Jiao Tong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 30 Years

Inclusion criteria

Inclusion criteria: 1. PWS patients; 2. For adults BMI>=30 kg/m2; for kids, BMI>=the values corresponding to the BMI 30 kg/m2 of adults (reference: Cole, T. J. [2000]. "Establishing a standard definition for child; over weight and obesity worldwideinternational survey." BMJ 320: 1240-1245); 3. 5-30 years old; 4. Participate no other research project.

Exclusion criteria

Exclusion criteria: 1. People who used any drug or surgery for the purpose of weight control; 2. Alcoholic; 3. People that received medical treatments in the last 3 months for following diseases: cholecystitis, gallstones, gastro-intestinal ulcer, urinary infection, acute pyelonephritis, cystitis; 4. People received surgery on GI tract except for appendicectomy or that for hernia; 5. People with severe hepatic diseases, such as chronic or persisting hepatitis and sclerosis, and people with hepatic dysfunction (ALT or AST >= 2.5 times of upper normal limit); 6. People with acute or chronic renal dysfunction, and uremia; 7. People with gallstones; 8. People with organic diseases, such as tumor/cancer, coronary heart disease, miocardial infarction, stroke; 9. People with infectious disease such as pulmonary tuberculosis or AIDS; 10. People with epilepsy; 11. People with congenital heart disease; 12. People with systemic lupus erythematosus; 13. People with aplastic anemia, or Idiopathic thrombocytopenic purpura, or anemia (Hb<10g/dl); 14. Pregnant women; 15. People with severe psychological disease during last 6 months.

Design outcomes

Primary

MeasureTime frame
Height, weight, waist circumference, hip circumfer;blood Ketone Bodies;Inflammatory cytokines;CRP;Gut permeability;The compositioin of gut microbiota;The metabolism of gut microbiota;The metabolome of urine;Appetite-regulating hormones;Oral glucose tolerance test;Insulin release test;C peptide test;HBA1c;blood lipids;liver function;Abdominal ultrasound;genetic analysis for q13-15 region of chromosome 15;

Secondary

MeasureTime frame
Blood chemistry for kidney function;Blood electrolyte;Routine urianlysis;blood routine;blood gas and electrolyte analysis;

Contacts

Public ContactZHAO LI PING
lpzhao@sjtu.edu.cn+86 21 34204877

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026