Clinical trial NCT04118010: Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Official title: Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cystic Fibrosis
Dysbiosis
Keywords: Cystic Fibrosis
Gastrointestinal Dysbiosis
Vitamin D
Prebiotic
Inulin
Gut microbiome
Intestinal inflammation
Intestinal absorption
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2019-10-07
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Shannon Index
timeFrame: Baseline, 12 weeks post-intervention
measure: Change in Species Richness Index From Baseline
timeFrame: Baseline, 12 weeks post-intervention
Secondary outcomes:
measure: Change in GI Microbiota Diversity
timeFrame: Baseline, 12 weeks post-intervention
measure: Change in GI Microbiota Richness
timeFrame: Baseline, 12 weeks post-intervention
measure: Change in GI Microbiota Composition
timeFrame: Baseline, 12 weeks post-intervention
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Vin Tangpricha, MD
role: PRINCIPAL_INVESTIGATOR
References: