Page Title
Clinical Trial Finder
Nutritional-GI Completed with Results
Phase 2 study of oral glutathione in children with cystic fibrosis (GROW-IP-16)
This study evaluated the safety and effectiveness of the oral glutathione in children with CF who use pancreatic enzyme replacement therapy (PERT).
Participants were randomly assigned to receive oral glutathione (3 doses per day for a total dose of 65 mg/kg) or to receive placebo (3 doses per day for a total of 65mg/kg) for 24 weeks.
Eligibility
See other primary eligibility criteria for more information.
-
Age:
24 Months to 10 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have a weight-for-age between the 10th and 50th percentiles at screening.
Study Results
-
What We Learned:
This study found that oral glutathione does not have an impact on improving weight or body mass index (BMI) in children with CF who use pancreatic enzyme replacement therapy (PERT). Oral glutathione was well-tolerated.
-
Primary Findings:
Effectiveness:
This study was conducted between July 2017 and December 2018. The study enrolled 60 participants and 58 participants completed the study (glutathione N=30; placebo N=28).
The primary objective of the study was to evaluate change in weight from the start of the study through the end of the study. This study did not meet its primary endpoint.
Over the 24-week study, both groups had minimal change in their average weight compared to other children with CF of the same age and sex. The change in weight (Z-score) in the group taking glutathione was -0.02 and the change in the group taking placebo was 0.04. Comparing the two groups, no significant difference in the change in weight over the study (p=0.25) was noticed.
Changes in body mass index (BMI) throughout the study were similar for the two groups. Participants taking glutathione had their BMI increase by an average of 0.04 kg/m2 at the end of 24 weeks and participants taking placebo had their BMI increase by an average of 0.10 kg/m2. Comparing the two groups, there was no significant difference in the change in BMI over the study (p=0.69).
Additionally, no differences were noticed between the groups with respect to changes in biomarkers that evaluate inflammation, including high sensitivity-C-reactive protein (p=0.47) and fecal calprotectin (p=0.43).
Safety:
Overall, glutathione was well-tolerated.
These data were provided from an NACFC abstract and have not been peer-reviewed.
-
Citation:
J Pediatr Gastroenterol Nutr 2020;DOI 10.1097/MPG.0000000000002948;71(6):771-777
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
-
Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
6 months -
Number of Study Visits:
4
Additional Information
-
Phase: ?more info
Phase Two -
Study Sponsor: ?more info
Schwarzenberg, Sarah -
Study Drugs:
Eligibility
See other primary eligibility criteria for more information.
-
Age:
24 Months to 10 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Other Primary Eligibility Criteria
Participants must have a weight-for-age between the 10th and 50th percentiles at screening.

CONTACT THE CLINICAL TRIAL NAVIGATOR
Get personalized assistance and answers to your clinical trial questions.
Learn MoreSign up for clinical trial alerts
Get email updates about clinical trials that matter to you.
Check the Drug Development Pipeline
We’re attacking CF from every angle. Learn about the status of CF drugs in development.
Learn More