Treatment of Functional Bowel Disorders

Launched by NATIONAL INSTITUTE OF DIABETES AND DIGESTIVE AND KIDNEY DISEASES (NIDDK) · Aug 8, 2000

Keywords

ClinConnect Summary

Female patients (aged 18-65) with FBD (irritable bowel syndrome, painful constipation and/or functional abdominal pain) will be enrolled at UNC-Chapel Hill and Toronto, Canada. A severity index will determine recruitment into the group of moderate FBD (200 patients) and severe FBD (100 patients). Each group will be randomized into the three treatment arms (cognitive-behavioral treatment, desipramine, and education/attention placebo), treated over a 12-week period, and followed for one year. Outcome measures will include symptoms (standardized abdominal pain, stool form and frequency) using ...

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Literate, female patients aged 18-65.
• • Symptoms present at least 2 days/week for greater than 6 months.
• • Diagnosis of functional bowel disorder (to be subcategorized using ''Rome'' Criteria.
• • Moderate (MFBD) or severe (SFBD) functional bowel disorder (FBD) based on the Functional Bowel Disorder Severity Index (FBDSI) developed in our pilot study. SFBD will be defined as a score of 110 and MFBD will be defined as a score between 36 and 110.
• • Discontinuation of all antidepressant medications for at least 3 months.
• • Use of acceptable method of birth control.
• Exclusion Criteria:
• • Evidence of lactose intolerance to explain bowel symptoms.
• • Heart disease.
• • Cardiac arrhythmias.
• • Severe psychiatric disorder (e.g., bipolar, suicide attempts).
• • Previous use of desipramine.
• • Glaucoma.
• • Urinary retention.
• • Pregnancy.
• • Alcohol consumption 3oz/day that would preclude participation or prevent data assessment.
• • Systemic gastrointestinal diseases or previous surgery that would interfere with the interpretation of symptoms or physiology.
• • Bipolar disorder.
• • Schizophrenia.
• • Substance abuse/dependency.
• • Previous use of desipramine.