Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03548480
Other study ID # FSJD-BALPWS-2018
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2018
Est. completion date January 31, 2019

Study information

Verified date March 2020
Source Fundació Sant Joan de Déu
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The gut microbiome has recently emerged as a major contributor to obesity, systemic inflammation, and metabolic disease. Furthermore, intestinal bacteria are crucial players in the gut-brain axis, regulating a broad range of central nervous system processes, from satiety mechanisms to anxiety and social behavior. Thus, targeting the microbiome is being actively investigated as a therapeutic strategy for a wide array of diseases, including obesity, anxiety, depression, and autism. Among all intestinal bacteria, Bifidobacterium animalis spp. lactis (BAL) has shown promise for obesity treatment in experimental animal models and human subjects, improving body composition and metabolic health, and reducing energy intake. Moreover, tryptophan metabolism, a crucial regulator of satiety mechanisms and anxiety, is a main target of BAL. Given that clinical manifestations of Prader-Willi syndrome (PWS) include hyperphagia, anxiety, altered body composition, and metabolic dysregulation, the aforementioned effects of BAL might prove highly beneficial for children with PWS. Here, the investigators will test this hypothesis by performing a randomized double-blinded placebo-controlled crossover clinical study to assess the effects of BAL supplementation on an array of clinical manifestations of PWS. Children with PWS will undergo a 3-month placebo/probiotic treatment period, a 3-month washout period, followed by a 3-month probiotic/placebo supplementation. Anthropometric, biochemical, and psychological data as well as biological samples will be obtained at the beginning of the study, and after each of the study periods, with a total of four time-points. Specifically, the investigators will determine body composition by DXA analysis; metabolic health by assessing glucose and lipid metabolic parameters as well as circulating hormonal and cytokine levels; thermoregulation by non-invasive thermal imaging; and hyperphagia and emotional and behavioral problems by applying parental-rated validated questionnaires.


Recruitment information / eligibility

Status Completed
Enrollment 39
Est. completion date January 31, 2019
Est. primary completion date January 31, 2019
Accepts healthy volunteers No
Gender All
Age group 2 Years to 19 Years
Eligibility Inclusion Criteria:

- Diagnosed with Prader-Willi Syndrome with genetic confirmation

- On a stable diet and medication regimen for at least the last two months before enrollment

Exclusion Criteria:

- Current enrollment in or discontinuation within the last 30 days from a clinical trial

- Presence of other medical problems that would preclude study participation

- Patients with a history of bariatric surgery

- Unsuitable for inclusion in the study in the opinion of the investigator

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Placebo
Intervention with a daily dose of placebo
Probiotic
Intervention with a daily dose of probiotic

Locations

Country Name City State
Spain Hospital Sant Joan de Deu Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundació Sant Joan de Déu

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in plasma metabolome Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of plasma samples 3 months
Other Change in urine metabolome Liquid chromatography coupled to mass spectrometry will be used to obtain a comprehensive metabolic profile of urine samples 3 months
Other Change in intestinal microbiome DNA isolated from fecal samples will be analyzed by sequencing. 3 months
Primary Change in percent body fat Measured by DXA scan 3 months
Secondary Change in lipid profile (triglyceride, cholesterol) Blood test after overnight fasting 3 months
Secondary Change in glucose metabolic parameters (glucose, insulin, HbA1c) Blood test after overnight fasting 3 months
Secondary Change in circulating cytokine levels Quantified in plasma samples 3 months
Secondary Change in hyperphagia Measured by validated questionnaire (HQ-CT) 3 months
Secondary Change in thermoregulation Measured by thermal imaging 3 months
See also
  Status Clinical Trial Phase
Recruiting NCT05032326 - Long-term Interventional Follow-up Study of Children With Prader-Willi Syndrome Included in the OTBB3 Clinical Trial Phase 3
Completed NCT04526379 - Study of Emotion and Cognition Abilities of Children With PWS and Proposition of an Innovative Remediation N/A
Terminated NCT03458416 - A Study to Assess the Long-Term Safety of Pharmaceutical Grade Synthetic Cannabidiol Oral Solution in Participants With Prader-Willi Syndrome Phase 2
Completed NCT03718416 - Natural History Study of Serious Medical Events in PWS
Completed NCT05322096 - Study to Evaluate Efficacy, Safety, and Tolerability of RGH-706 in Prader-Willi Syndrome Phase 2
Completed NCT02205450 - Growth Hormone in Children Under 2 Years With Prader-Willi in Hospital of Sabadell
Terminated NCT02179151 - Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi Syndrome Phase 3
Completed NCT00375089 - Characteristics of Prader-Willi Syndrome and Early-onset Morbid Obesity N/A
Completed NCT00004351 - Study of Phenotype and Genotype Correlations in Patients With Contiguous Gene Deletion Syndromes N/A
Recruiting NCT05938543 - Cerebellar TMS and Satiety in Prader-Willi Syndrome N/A
Suspended NCT05879614 - An Open-Label Study of Oral NNZ-2591 in Prader-Willi Syndrome (PWS-001) Phase 2
Recruiting NCT03031626 - Oxygen Versus Medical Air for Treatment of CSA in Prader Will Syndrome Phase 4
Withdrawn NCT04086810 - An Open-Label Study of DCCR Tablet in Patients With PWS Phase 3
Completed NCT02629991 - Oxytocin vs. Placebo for the Treatment Hyperphagia in Children and Adolescents With Prader-Willi Syndrome Phase 2
Recruiting NCT02297022 - Deep Brain Stimulation for the Treatment of Obesity in Patients With Prader-Willi Syndrome Phase 1
Not yet recruiting NCT02263781 - PREPL in Health and Disease N/A
Completed NCT00551343 - Gut Derived Hormones, Body Composition and Metabolism in Prader-Willi Syndrome N/A
Recruiting NCT06448871 - Ultrasound to Assess Sarcopenia in Prader Willi Syndrome
Enrolling by invitation NCT03655223 - Early Check: Expanded Screening in Newborns
Recruiting NCT05939453 - Impact of Bright Light Therapy on Prader-Willi Syndrome N/A