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Prebiotic

Vitamin D3 and Inulin for Imbalance of Microbes

Phase 4
Waitlist Available
Led By Vin Tangpricha, MD
Research Sponsored by Emory University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 12 weeks post-intervention
Awards & highlights

Study Summary

This trial will study if giving high doses of vitamin D and a prebiotic called inulin to people with Cystic Fibrosis can help reduce gut dysbiosis and improve intestinal function.

Eligible Conditions
  • Imbalance of Microbes
  • Cystic Fibrosis

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 12 weeks post-intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 12 weeks post-intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Species Richness Index From Baseline
Shannon Index
Secondary outcome measures
Change in GI Microbiota Composition
Change in GI Microbiota Diversity
Change in GI Microbiota Richness

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Placebo vitamin D3 and InulinActive Control2 Interventions
Matching to Vitamin D3 placebo capsules, and 12 g/day chicory-derived prebiotic inulin for 12 weeks
Group II: Vitamin D3 and InulinActive Control2 Interventions
Vitamin D3 50,000 IU/week and 12 g/day chicory-derived prebiotic inulin for 12 weeks
Group III: Vitamin D3 and placebo InulinActive Control2 Interventions
Vitamin D3 50,000 IU/week and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks
Group IV: Placebo vitamin D3 and placebo InulinPlacebo Group2 Interventions
Matching to Vitamin D3 placebo capsules, and 12 g/day corn-derived maltodextrin/day as the prebiotic placebo for 12 weeks

Find a Location

Who is running the clinical trial?

Emory UniversityLead Sponsor
1,640 Previous Clinical Trials
2,560,656 Total Patients Enrolled
Vin Tangpricha, MD4.47 ReviewsPrincipal Investigator - Emory University
Emory University
1 Previous Clinical Trials
1Patient Review
I would recommend that you obtain your entire medical file from this doctor, especially the doctor's notes. Make sure to cross-reference what he says with what is actually documented.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis
Vin Tangpricha 2020. "Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04118010.
~8 spots leftby Apr 2025
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