Prader-Willi SyndromeNCT05791604
The Intervention of Obesity in Children With Prader-Willi Syndrome Using Prebiotics and Probiotics
A study testing probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG and Prebiotics with galactomannan and oligofructose in people with Prader-Willi Syndrome, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 10 years
- Conditions the study is for
- Prader-Willi Syndrome
- What is being tested?
- probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG and Prebiotics with galactomannan and oligofructose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2023to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Pre-adolescent children with Prader Willi syndrome which were definitely diagnosed by gene testing.
- Consistent with the diagnostic criteria for obesity.
- Not participate in other research projects at present or three months before the research;
- Agree to participate in the test and obtain the consent of their parents; voluntarily be the subjects and sign the informed consent form.
Who cannot join
- Losing weight in ways other than the intervention measures of this project, such as taking weight loss drugs or known drugs that cause weight change;
- Use antibiotics within 1 month before the study and lasted for 3 days or more;
- Use probiotics within 1 month before the study and lasted for 3 days or more;
- Complicated with liver and renal insufficiency (alanine aminotransferase and serum creatinine indexes exceed 2 times the upper limit of the normal value set by the hospital);
- Have gastrointestinal diseases affecting food digestion and absorption (such as severe diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, acute cholecystitis, etc.); severe diarrhea refers to watery stool 3 or more times a day and lasts for 3 or more days. severe constipation refers to defecation 2 or less times a week with difficulty in defecation;
- Surgery was performed within 1 year before the study (except for appendicitis and hernia surgery);
- Have hepatitis B, active tuberculosis, AIDS and other infectious diseases;
- Those who are suffering from mental illness and are taking psychotropic drugs such as antidepressants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
Wei Lui, 86-021-64933281, wei_lu@fudan.edu.cn
About this study
Official title: The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
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.
Read the detailed description
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.
- Conditions
- Prader-Willi Syndrome
- Being tested
- probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG, Prebiotics with galactomannan and oligofructose
- Keywords
- Prader-Willi syndrome, Probiotics, Prebiotics
- Medical subject headings
- Prader-Willi Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GGDietary supplement
Take probiotics, 2g each time, twice a day, for 12 weeks
Prebiotics with galactomannan and oligofructoseDietary supplement
Take probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Probiotics group | Experimental | Take probiotics during the study Receives: Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG |
| Probiotics and prebiotics group | Experimental | Take probiotics and prebiotics during the study Receives: Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG; Dietary Supplement: Prebiotics with galactomannan and oligofructose |
| Control group | No intervention | Take placebo food during the study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (16)
Body composition
Body composition including body fat percentage will be measured through body composition meter.
Measured: 4 weeks and 12 weeks
The structure of gut microbiota
The 16s rRNA genes of fecal samples were analyzed.
Measured: 4 weeks and 12 weeks
Height
The height is accurate to 0.1cm.
Measured: 4 weeks and 12 weeks
Weight
The weight is accurate to 0.1kg.
Measured: 4 weeks and 12 weeks
Waist circumference
The waist circumference is accurate to 0.1cm.
Measured: 4 weeks and 12 weeks
Glycosylated hemoglobin level
The glycosylated hemoglobin is accurate to 0.1%.
Measured: 4 weeks and 12 weeks
Fast triglyceride level
The fast triglyceride level will be measured by IMMULITE 1000 (Siemens,Germany).
Measured: 4 weeks and 12 weeks
Fast total cholesterol level
The fast total cholesterol level will be measured by IMMULITE 1000 (Siemens,Germany).
Measured: 4 weeks and 12 weeks
Fast low density lipoprotein level
The fast low density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Measured: 4 weeks and 12 weeks
Fast high density lipoprotein level
The fast high density lipoprotein level will be measured by IMMULITE 1000 (Siemens,Germany).
Measured: 4 weeks and 12 weeks
Defecation status
Care givers describe the defecation status in the past 1 week, including the frequency, nature, and color.
Measured: 4 weeks and 12 weeks
Abdominal pain
Care givers describe whether abdominal pain occurs, and if so, provide frequency.
Measured: 4 weeks and 12 weeks
Excessive flatulence
Care givers describe whether excessive flatulence occurs, and if so, provide frequency.
Measured: 4 weeks and 12 weeks
Fast insulin level
The fast insulin level will be measured by IMMULITE 1000 (Siemens,Germany).
Measured: 4 weeks and 12 weeks
Fast glucose level
The fast glucose level is detected by fingertip blood with blood glucose meter.
Measured: 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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Apr 2023
- Primary completion31 Mar 2028 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prader-Willi SyndromeStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wei Lu, Dr, Study director, Children's Hospitial of Fudan Univeristy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791604
- Sponsor's protocol ID
- PREPROPWS
- Status last verified
- Jul 2026
- First submitted
- 6 Mar 2023
- Last updated
- 6 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: After applying to the researcher, the researcher will decide whether to share the data
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectiveness Study of Prebiotics and Probiotics in the Intervention of Obesity in Children With Prader-Willi Syndrome
- ClinicalTrials.gov ID
- NCT05791604
- Acronym / sponsor ID
- PREPROPWS
- Conditions
- Prader-Willi Syndrome
- Keywords
- Prader-Willi syndrome, Probiotics, Prebiotics
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Probiotics group | Experimental | Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GGTake probiotics during the study |
| Probiotics and prebiotics group | Experimental | Dietary Supplement: probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG, Dietary Supplement: Prebiotics with galactomannan and oligofructoseTake probiotics and prebiotics during the study |
| Control group | No intervention | –Take placebo food during the study |
Who may qualify
- Ages
- 3 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Pre-adolescent children with Prader Willi syndrome which were definitely diagnosed by gene testing.
- Consistent with the diagnostic criteria for obesity.
- Not participate in other research projects at present or three months before the research;
- Agree to participate in the test and obtain the consent of their parents; voluntarily be the subjects and sign the informed consent form.
Key exclusion criteria (8 listed)
- Losing weight in ways other than the intervention measures of this project, such as taking weight loss drugs or known drugs that cause weight change;
- Use antibiotics within 1 month before the study and lasted for 3 days or more;
- Use probiotics within 1 month before the study and lasted for 3 days or more;
- Complicated with liver and renal insufficiency (alanine aminotransferase and serum creatinine indexes exceed 2 times the upper limit of the normal value set by the hospital);
- Have gastrointestinal diseases affecting food digestion and absorption (such as severe diarrhea, constipation, severe gastrointestinal inflammation, active gastrointestinal ulcer, acute cholecystitis, etc.); severe diarrhea refers to watery stool 3 or more times a day and lasts for 3 or more days. severe constipation refers to defecation 2 or less times a week with difficulty in defecation;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GGTake probiotics, 2g each time, twice a day, for 12 weeks | Dietary supplement | Probiotics and prebiotics group, Probiotics group |
| Prebiotics with galactomannan and oligofructoseTake probiotics, 2g each time, twice a day, for 12 weeks Take prebiotics, 25g each time, twice a day, for 12 weeks | Dietary supplement | Probiotics and prebiotics group |
Primary outcome
Body mass index
Time frame: 12 weeks
Body mass index is calculated as weight (kg)/[Height (m)^2]. Weight and height will be combined to report BMI in kg/m^2.
16 secondary outcomes
Body composition
Time frame: 4 weeks and 12 weeks
The structure of gut microbiota
Time frame: 4 weeks and 12 weeks
Height
Time frame: 4 weeks and 12 weeks
Weight
Time frame: 4 weeks and 12 weeks
Waist circumference
Time frame: 4 weeks and 12 weeks
Glycosylated hemoglobin level
Time frame: 4 weeks and 12 weeks
Fast triglyceride level
Time frame: 4 weeks and 12 weeks
Fast total cholesterol level
Time frame: 4 weeks and 12 weeks
Fast low density lipoprotein level
Time frame: 4 weeks and 12 weeks
Fast high density lipoprotein level
Time frame: 4 weeks and 12 weeks
Defecation status
Time frame: 4 weeks and 12 weeks
Abdominal pain
Time frame: 4 weeks and 12 weeks
Excessive flatulence
Time frame: 4 weeks and 12 weeks
Fast insulin level
Time frame: 4 weeks and 12 weeks
Fast glucose level
Time frame: 4 weeks and 12 weeks
Body mass index
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2026.
- Individual participant dataSharing planned: No. After applying to the researcher, the researcher will decide whether to share the data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wei Lu, Dr study director
Children's Hospitial of Fudan Univeristy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing probiotics including B. lactis B420, B. lactis HN019, B. animalis Bb-12, L. rhamnosus GG and Prebiotics with galactomannan and oligofructose in people with Prader-Willi Syndrome, run by Children's Hospital of Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei Lu, Dr (86-021-64933281, wei_lu@fudan.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body mass index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2026.