An interventional study of probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG and Prebiotics with galactomannan and oligofructose in Prader-Willi Syndrome, sponsored by Children's Hospital of Fudan University. Recruiting at 1 site in China. Open to participants aged 3 Years to 10 Years. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Children's Hospital of Fudan University · Not applicable, Interventional, and Treatment
Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. More and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children.
Prader-Willi syndrome (PWS) is a rare genetic disease, with hyperappetite and severe obesity. Morbid obesity and related complications caused by hyperappetite are the most common causes of poor prognosis and death in PWS. At present, there is no effective drugs and interventions to help control the appetite of PWS patients. At present, more and more evidence has shown that gut microbiota is closely related to obesity. Probiotics and prebiotics can improve the structure of gut microbiota, thus improve blood lipid levels and other biochemical indicators of obese people. Therefore, this study intends to explore the effectiveness and safety of probiotics and prebiotics in controlling appetite and weight gain of PWS children. Participants will be divided into three groups, receiving probiotics, probiotics+probiotics or placebo treatment, and observe the changes in body weight, the structure of gut microbiota and metabolic level.
144 studies on the registry are indexed under Prader-Willi Syndrome; 23 are open to participants now.
This study's planned enrollment of 60 is above the median of 30 across 100 interventional studies indexed under Prader-Willi Syndrome.
Browse Prader-Willi Syndrome studies →Children's Hospital of Fudan University is the lead sponsor of 268 studies on the registry; 95 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Take probiotics during the study
Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG
Take probiotics and prebiotics during the study
Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG · Dietary Supplement: Prebiotics with galactomannan and oligofructose
Take placebo food during the study
Take probiotics, 2g each time, twice a day, for 12 weeks
Drug pages: Prebiotics · Galactomannan · Oligofructose
Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks
Body mass index
Body mass index is calculated as weight (kg)/\[Height (m)\^2\]. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 12 weeks
Body composition
Body composition including body fat percentage will be measured through body composition meter.
Time frame: 4 weeks and 12 weeks
The structure of gut microbiota
The 16s rRNA genes of fecal samples were analyzed.
Time frame: 4 weeks and 12 weeks
Height
The height is accurate to 0.1cm.
Time frame: 4 weeks and 12 weeks
Weight
The weight is accurate to 0.1kg.
Time frame: 4 weeks and 12 weeks
Waist circumference
The waist circumference is accurate to 0.1cm.
Time frame: 4 weeks and 12 weeks
Glycosylated hemoglobin level
The glycosylated hemoglobin is accurate to 0.1%.
Time frame: 4 weeks and 12 weeks
Fast triglyceride level
The fast triglyceride level will be measured by IMMULITE 1000 (Siemens,Germany).
Time frame: 4 weeks and 12 weeks
Fast total cholesterol level
The fast total cholesterol level will be measured by IMMULITE 1000 (Siemens,Germany).
Time frame: 4 weeks and 12 weeks
Fast low density lipoprotein level
The fast low density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Time frame: 4 weeks and 12 weeks
Fast high density lipoprotein level
The fast high density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Time frame: 4 weeks and 12 weeks
Defecation status
Care givers describe the defecation status in the past 1 week, including the frequency, nature, and color.
Time frame: 4 weeks and 12 weeks
Abdominal pain
Care givers describe whether abdominal pain occurs, and if so, provide frequency.
Time frame: 4 weeks and 12 weeks
Excessive flatulence
Care givers describe whether excessive flatulence occurs, and if so, provide frequency.
Time frame: 4 weeks and 12 weeks
Fast insulin level
The fast insulin level will be measured by IMMULITE 1000 (Siemens,Germany).
Time frame: 4 weeks and 12 weeks
Fast glucose level
The fast glucose level is detected by fingertip blood with blood glucose meter.
Time frame: 4 weeks and 12 weeks
Body mass index
Body mass index is calculated as weight (kg)/\[Height (m)\^2\]. Weight and height will be combined to report BMI in kg/m\^2.
Time frame: 4 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — After applying to the researcher, the researcher will decide whether to share the data
Started Apr 2023 (actual). Primary completion is estimated for Mar 2028, 59 months after the start.
Of 19 interventional studies with no phase under Prader-Willi Syndrome, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 43. This study's planned 59 months is above that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drugs tested here: Prebiotics · Galactomannan · Oligofructose
Children's Hospital of Fudan University →