Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

Official title:

Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04118010
• Other study ID #: IRB00114230
• Status: Completed
• Phase: Phase 4
• Start date: March 13, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2024
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis with the additive or synergistic effects of the combination of vitamin D + inulin.

Description:

Cystic fibrosis (CF) is the most common life-shortening genetic condition among Caucasians in the United States. Individuals with CF have an altered gastrointestinal (GI) microbiota, which may be a result of chronic systemic inflammation and infection, frequent use of antibiotics, and/or medically prescribed and habitual high-fat/high-calorie diets. The study will assess if administration of high-dose vitamin D and a commonly used prebiotic (inulin) is effective to reduce gastrointestinal dysbiosis and to improve critical intestinal functions in Cystic Fibrosis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. male and female patients (age > 18 years) with confirmed CF by genetic mutation and/or sweat chloride testing,

2. not currently on oral or systemic antibiotics for pulmonary exacerbation,

3. vitamin D deficient/insufficient (25(OH)D, 6 - 30 ng/mL) with most recent 25(OH)D in the past 12 months,

4. use of CFTR modulator therapy is allowed

Exclusion Criteria:

1. severe vitamin D deficiency 25(OH)D = 5 ng/mL or hypocalcemia or hypercalcemia,

2. active GI disease, abdominal pain and/or diarrhea,

3. chronic kidney disease worse than stage 3 (eGFR < ml/min per 1.73 m2),

4. any vitamin D supplement use >2,000 IU or vitamin D analogue (patients who are taking more than 2,000 IU of vitamin D must agree to stop the vitamin D for 6 weeks and take less than 2,000 IU of vitamin D during the study),

5. use of immunosuppressants or history of organ transplantation,

6. current use of probiotics or prebiotics

Related Conditions & MeSH terms

• Cystic Fibrosis
• Dysbiosis
• Fibrosis

Intervention

Drug:
• Vitamin D3
High-dose vitamin D3 50,000 IU /week for 12 weeks
• Placebo vitamin D3
Matching to Vitamin D3 placebo capsules for 12 weeks
• Inulin
Chicory-derived prebiotic inulin 12 g/day for 12 weeks
• Placebo Inulin
Corn-derived maltodextrin 12g/day as the prebiotic placebo for 12 weeks

Locations

Country	Name	City	State
United States	Emory Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shannon Index	The Shannon Index is a measure of diversity of microbial species that takes into account both abundance (the number of species present) and evenness (how close the numbers for each species are). The Shannon index can be calculated using the following equation: H= -?(i=1)^s pi ln(pi). A value of zero for H indicates that a community has only one species. The higher the value of H, the higher the diversity of species in a particular community.; Sputum microbiota analysis was measured using this ecological diversity measure. Sputum samples were collected via a sputum kit.	Baseline, 12 weeks post-intervention
Primary	Change in Species Richness Index From Baseline	Stool microbiota analysis will be measured using this ecological diversity measure. Stool samples will be collected using a stool kit provided to the participant.	Baseline, 12 weeks post-intervention
Secondary	Change in GI Microbiota Diversity	Changes in GI microbiota diversity will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota diversity will be reported as the Shannon Index.	Baseline, 12 weeks post-intervention
Secondary	Change in GI Microbiota Richness	Changes in GI microbiota richness will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota richness will be reported as a number of populations of microorganisms.	Baseline, 12 weeks post-intervention
Secondary	Change in GI Microbiota Composition	Changes in GI microbiota composition will be determined using 16S rRNA gene sequencing and microbiome-dependent metabolites pathways in stool and plasma using high-resolution metabolomics analysis.Changes in GI microbiota composition will be reported as a percentage of bacteria.	Baseline, 12 weeks post-intervention