Crohn Disease Clinical Trial
Official title:
Crossover Study on Human Exposure to Phthalates and Male Fertility
The purpose of this study is to investigate the relationship of high exposure to dibutyl
phthalate (DBP) from the use of Asacol with clinical and intermediate markers of male
fertility, including semen quality, sperm DNA damage, transcript profiles of sperm mRNA and
sncRNAs, and reproductive hormones.
Hypothesis 1: High exposure to DBP from the use of Asacol is associated with decreased sperm
concentration and motility, and increased sperm DNA damage.
Hypothesis 2: High exposure to DBP from the use of Asacol is associated with decreased serum
testosterone, altered LH:testosterone ratio, and decreased inhibin-B.
Hypothesis 3: High exposure to DBP from the use of Asacol is associated with altered
transcript profiles of sperm mRNAs and sncRNAs.
There are 2 ways you can participate in the study.
OPTION 1 involves 6 one-hour visits to the Massachusetts General Hospital (MGH) Andrology
Clinic over a 9 month period. At each visit you would be asked to fill out questionnaires and
to provide a urine, semen, and blood sample. Following Visit 2, you are asked to switch your
brand of mesalamine medication. After 4 months, you change back to your original brand of
medication. The change in medication will be done in consultation with your primary GI
doctor. If the cost of co-payment is greater for the new brand of medication, we will provide
compensation to cover the difference. In the case you do not have prescription drug health
insurance coverage, the study will reimburse up to $4000 to cover the cost for Asacol,
Pentasa or Lialda medication taken during your study participation.
OPTION 2 involves 4 one-hour visits to MGH Andrology clinic. At each visit you complete
questionnaires and provide a blood, urine and semen sample. You are eligible for Option 2 if
you are currently taking Asacol or Asacol HD and do not want to change your medication.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04046913 -
The ADDapt Diet in Reducing Crohn's Disease Inflammation
|
N/A | |
| Recruiting |
NCT05169593 -
Prevention of Postoperative Endoscopic Recurrence With Endoscopy-driven Versus Systematic Biological Therapy
|
Phase 4 | |
| Recruiting |
NCT06116604 -
Early Bowel Resection for Terminal Ileal Crohn's Disease
|
||
| Recruiting |
NCT05294107 -
Intestinal Organoids
|
N/A | |
| Recruiting |
NCT05316584 -
A Novel Remote Patient and Medication Monitoring Solution to Improve Adherence and PerSiStence With IBD Therapy
|
N/A | |
| Recruiting |
NCT05627128 -
A Culturally Tailored Dietary Intervention to Treat Crohn's Disease
|
N/A | |
| Withdrawn |
NCT04349449 -
ENTYVIO in Bio-naive Patients With Moderate/Severe Crohn's Disease (CD) in Daily Practice
|
||
| Completed |
NCT05051943 -
A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
|
||
| Completed |
NCT03058679 -
Trial of Specific Carbohydrate and Mediterranean Diets to Induce Remission of Crohn's Disease
|
N/A | |
| Completed |
NCT02871635 -
BI 695501 Versus Humira in Patients With Active Crohn's Disease: a Trial Comparing Efficacy, Endoscopic Improvement, Safety, and Immunogenicity
|
Phase 3 | |
| Recruiting |
NCT04539665 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease.
|
N/A | |
| Recruiting |
NCT04266600 -
Extended Mesenteric Excision in Ileocolic Resections for Crohn's Disease
|
N/A | |
| Recruiting |
NCT03913572 -
Treatment of Perianal Disease Using Adipose-derived Stem Cells
|
||
| Completed |
NCT03606499 -
Real-world Effectiveness of Ustekinumab in Participants Suffering From Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitis) With Extra-intestinal Manifestations or Immune-mediated Inflammatory Diseases
|
||
| Completed |
NCT03668249 -
A Study to Characterize Multidimensional Model to Predict the Course of Crohn's Disease (CD)
|
||
| Terminated |
NCT04102111 -
A Study Evaluating Participants With Moderately to Severely Active Crohn's Disease
|
Phase 2 | |
| Recruiting |
NCT04997733 -
Fecal Microbiota Transplantation in Crohn's Disease as Relay After Anti-TNF Withdrawal
|
Phase 3 | |
| Recruiting |
NCT05906576 -
Post-marketing Registry Study of Infliximab for Injection in Chinese Pediatric Crohn's Disease Patients
|
Phase 4 | |
| Not yet recruiting |
NCT04398836 -
Preoperative Nutrition for Crohn's Disease Patients
|
Phase 3 | |
| Not yet recruiting |
NCT04502303 -
18F-FDG and 68Ga-FAPI PET/CT in Crohn's Disease
|
Phase 2 |