Inflammation Clinical Trial
Official title:
The Effects of Naltrexone in Active Crohn's Disease
It is hypothesized that the opioid antagonist naltrexone will improve inflammation of the
bowel and quality of life in subjects with active Crohn's disease compared to placebo. In
order to test this hypothesis the following specific aims are proposed:
1. Evaluate the effects of low dose naltrexone compared to placebo on the activity of
Crohn's disease by the following end points: Crohn's Disease Activity Index (CDAI), pain
assessment, laboratory values (CRP and ESR), endoscopic appearance, histology, and
quality of life surveys;
2. Examine the effects of naltrexone given over 3 months compared to 6 months for
durability of response;
3. Determine the safety and toxicity of low dose naltrexone in subjects with active Crohn's
disease, and
4. Study the mechanism by which naltrexone exerts its effect by measuring plasma enkephalin
levels of subjects on therapy.
Purpose statement: The purpose of this study is to evaluate the effects of low dose
naltrexone in a blinded placebo controlled study to determine the safety and efficacy of this
compound in those with active Crohn's disease.
Study design : The study is designed as a double-blind placebo controlled study for 3 months followed by a pseudo cross-over such that all subjects receiving placebo the first 3 months will receive active drug the second 3 months and all receiving naltrexone the first 3 months remain on the drug the last 3 months of this 6 month study. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03995979 -
Inflammation and Protein Restriction
|
N/A | |
| Completed |
NCT03255187 -
Effect of Dietary Supplemental Fish Oil in Alleviating Health Hazards Associated With Air Pollution
|
N/A | |
| Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
| Completed |
NCT03577223 -
Egg Effects on the Immunomodulatory Properties of HDL
|
N/A | |
| Completed |
NCT04383561 -
Relationship Between LRG and Periodontal Disease
|
N/A | |
| Active, not recruiting |
NCT03622632 -
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association
|
||
| Completed |
NCT06216015 -
Exercise Training and Kidney Transplantation
|
N/A | |
| Completed |
NCT04856748 -
Nomogram to Diagnose Prostatic Inflammation (PIN) in Men With Lower Urinary Tract Symptoms
|
||
| Completed |
NCT05529693 -
Efficacy of a Probiotic Strain on Level of Markers of Inflammation in an Elderly Population
|
N/A | |
| Recruiting |
NCT05415397 -
Treating Immuno-metabolic Depression With Anti-inflammatory Drugs
|
Phase 3 | |
| Recruiting |
NCT05670301 -
Flemish Joint Effort for Biomarker pRofiling in Inflammatory Systemic Diseases
|
N/A | |
| Recruiting |
NCT05775731 -
Markers of Inflammation and of the Pro-thrombotic State in Hospital Shift and Day Workers
|
||
| Recruiting |
NCT04543877 -
WHNRC (Western Human Nutrition Research Center) Fiber Intervention Study
|
Early Phase 1 | |
| Completed |
NCT03859934 -
Metabolic Effects of Melatonin Treatment
|
Phase 1 | |
| Completed |
NCT03429920 -
Effect of Fermented Soy Based Product on Cardiometabolic Risk Factors
|
N/A | |
| Completed |
NCT06065241 -
Quantifiably Determine if the Botanical Formulation, LLP-01, Has a Significant Clinical Effect on Proteomic Inflammatory Biomarkers and Epigenetic Changes in Healthy, Older Individuals.
|
N/A | |
| Completed |
NCT05864352 -
The Role of Dietary Titanium Dioxide on the Human Gut Microbiome and Health
|
||
| Completed |
NCT03318731 -
Efficacy and Safety of Fenugreek Extract on Markers of Muscle Damage and Inflammation in Untrained Males
|
N/A | |
| Not yet recruiting |
NCT06134076 -
Comparing Effects of Fermented and Unfermented Pulses and Gut Microbiota
|
N/A | |
| Not yet recruiting |
NCT05910489 -
Micro and Nanoplastics in Greenhouse Workers: Biomarkers of Exposure and Effect
|