The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Oral Glutathione; Placebo
Intervention description: Oral Glutathione oral powder; Placebo oral powder
Phase: Phase 2
Study type: Interventional
Primary purpose: Supportive Care
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 60.0
Sex: All
Minimum age: 2 Years
Maximum age: 11 Years
Healthy volunteers: No
Keywords: Growth Parameters; Cystic Fibrosis

Summary:

      The purpose of this randomized, placebo-controlled (Phase II) study will be to further
      evaluate the effects of oral glutathione on growth in children with CF.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Male or female ≥ 2 and < 11 years of age at Visit 1

          2. Documentation of a CF diagnosis as evidenced by the following criteria: Sweat chloride
             ≥ 60 mEq/L by quantitative pilocarpine iontophoresis test (QPIT) AND Two
             well-characterized mutations in the cystic fibrosis transmembrane conductive regulator
             (CFTR) gene

          3. Weight-for-age between the 10th and 50th percentiles at Screening (Visit 1) (using the
             Center for Disease Control (CDC) reference equations)

          4. Current chronic use, greater than 8 weeks before Day 0, of pancreatic enzyme
             replacement therapy (PERT) for management of pancreatic insufficiency

          5. Written informed consent (and assent when applicable) obtained from subject or
             subject's legal representative and ability to comply with the requirements of the
             study

          6. Clinically stable with no significant changes in health status within 2 weeks prior to
             Day 0

        Exclusion Criteria:

          -  1. Intestinal obstruction or gastrointestinal surgery within the 6 months prior to Day
             0 2. History of diabetes, Crohn's disease, celiac disease, or bowel resection 3. Use
             of either oral or inhaled GSH or N-acetyl cysteine within the 4 months prior to
             Screening (Visit 1) 4. Known hypersensitivity to oral glutathione or lactose 5.
             Initiation of any new chronic therapy (e.g., ibuprofen, hypertonic saline,
             azithromycin, Pulmozyme, Cayston TOBI Kalydeco,Orkambi, Proton Pump Inhibitor,
             Histamine H-2 Blocker [PPI/H2-blocker], Miralax® , PERT, dietary supplementation,
             probiotics) within the 4 weeks prior to Day 0 6. Changes in the amount of proprietary
             dietary supplement formulas (e.g., Scandishakes, Boost, Pediasure, or homemade
             formula) given (oral or gastrostomy tube) within the 4 weeks prior to Day 0 7. Use of
             antibiotics (oral, IV, or inhaled) for acute symptoms within the 2 weeks prior to Day
             0 8. Use of oral steroids within the 4 weeks prior to Day 0 9. Active treatment for
             nontuberculous mycobacteria (NTM) at Day 0 10. Active treatment for allergic
             bronchopulmonary aspergillosis (ABPA) at Day 0 11. Administration of any
             investigational drug within the 30 days prior to Day 0 12. Sibling who received study
             drug as part of this study 13. Presence of a condition or abnormality that in the
             opinion of the investigator would compromise the safety of the patient or the quality
             of the data