Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis

Emory University40 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Cystic Fibrosis Dysbiosis

Interventions

Vitamin D3DRUG

High-dose vitamin D3 50,000 IU /week for 12 weeks

Placebo vitamin D3DRUG

Matching to Vitamin D3 placebo capsules for 12 weeks

InulinDRUG

Chicory-derived prebiotic inulin 12 g/day for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Emory Clinic

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: Baseline, 12 weeks post-intervention

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.

Time frame: Baseline, 12 weeks post-intervention

Secondary Outcomes

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.

Time frame: Baseline, 12 weeks post-intervention

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.

Time frame: Baseline, 12 weeks post-intervention

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.

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.