Ensayos clínicos

Inclusion Criteria

Healthy volunteers - All participants will complete a validated bowel disease questionnaire

• HAD: No restrictions on Hospital Anxiety/Depression score.
• Age: 18-75 years
• Gender: Men or women. Ratio of 5 female to 1 male expected. Lactating and women are eligible. Women of childbearing potential will have a negative pregnancy test before initiation of the study. 
• Previous 48 hour fecal bile acid test measurement in either the clinical or research setting or previous fasting serum C4 measurement >52ng/mL. If no previous 48 hour total fecal bile acids were collected in the past, the participant will be asked to complete one during the study

IBS-D or chronic diarrhea- All participants will complete a validated bowel disease questionnaire

• BDQ- IBS symptoms: Positive by Rome IV criteria
• HAD: No restrictions on Hospital Anxiety/Depression score.
• Age: 18-75 years
• Gender: Men or women. Ratio of 5 female to 1 male expected. Lactating and women are eligible. Women of childbearing potential will have a negative pregnancy test before initiation of the study.  
• Previous 48 hour fecal bile acid test measurement in either the clinical or research setting or previous fasting serum C4 measurement >52ng/mL. If no previous 48 hour total fecal bile acids were collected in the past, the participant will be asked to complete one during the study

Ileal resection >10 cm - All participants will complete a validated bowel disease questionnaire

• HAD: No restrictions on Hospital Anxiety/Depression score.  
• Age: 18-75 years
• Gender: Men or women. Lactating and women are eligible. Women of childbearing potential will have a negative pregnancy test before initiation of the study. 

Exclusion criteria for IBS-D, chronic diarrhea and healthy volunteers

• Use of drugs or agents within the past 1 week or during the study period (birth control pill, estrogen replacement therapy, metformin and thyroxine replacement are permissible exceptions, hypertension agents, SSRI, SNRI):
  • Agents that alter GI transit including opioids, narcotics, anticholinergics, tricyclic antidepressants, SNRI antidepressants.
  • Analgesic drugs including opiates, NSAID, COX 2 inhibitors
  • Intake of medication that could interfere with the interpretation of the study. 
• Abdominal surgery (except appendectomy, hernia repairs and cholecystectomy); specifically, prior gastric surgery, vagotomy, cholecystectomy and any small bowel resection will be excluded.
• Female patients who are pregnant (in view of the changes in hepatic metabolism or cholestasis that may occur during pregnancy)
• Patients with known chronic liver disease or history of elevated AST/ALT 2.0 X ULN
• BA synthesis and possible false positive or negative fecal bile acid or serum 7alphaC4 result.no AST or ALT values in the medical record, the study physicians will determine if the tests need to be run.

Exclusion criteria for patients with ileal resection

The same as above except:   

• Abdominal surgery (except ileal resection, appendectomy, hernia repairs and cholecystectomy); specifically, prior gastric surgery, vagotomy, cholecystectomy and any colon resection will be excluded.